The problem of non-compliance with treatment and its repercussions on the clinical evolution of different conditions has been widely investigated.1–4 Non-compliance has also been shown to have significant economic implications, not only as a result of product loss but also indirectly through the complication of disease management and its subsequent healthcare and social costs.5–7Non-compliance as a health problemThe term “non-compliance” might be taken to refer both to the failure to follow a drug regimen and to the failure to adopt other (...) measures that contribute to improvement in health—for example, changes in lifestyle or diet. This letter focuses on the former.Non-compliance with a drug regimen can be the result of a number of different factors9–11 and a variety of techniques have been developed in an attempt to control it.12,13 Of these, the few techniques that have been shown to be effective have only managed to solve the problem in specific situations over short periods of time. The use of such techniques to control non-compliance, particularly where these are effective, raises interesting ethical questions about the extent to which their application constitutes an infringement of the patient’s right to decide on how to manage their own health.8 Here we suggest that in some cases one factor that leads to non-compliance is the tendency to provide extensive and exhaustive information on side effects in …. (shrink)

Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising. However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very (...) similar ethical concerns as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA. (shrink)

The Food and Drug Administration, as a matter of long-standing policy, does not inform the public of instances whereby applications for new drugs or new indications for existing drugs have been rejected by the agency or withdrawn from consideration, nor does it disclose the agency’s analyses of the data submitted with such applications. This lack of transparency is unjustified and prevents patients, researchers, and healthcare providers from gaining insight into why a drug’s application was not approved. The FDA’s (...) policy is particularly troubling in cases where the agency has found a currently marketed drug to be ineffective or unsafe for a newly proposed indication. Disclosure of the FDA’s findings in such cases would promote public health by encouraging healthcare providers to avoid prescribing drugs for unapproved uses that the agency has deemed to be potentially dangerous or ineffective. The FDA’s counterpart agencies in Europe and Canada have demonstrated the feasibility of disclosing information on rejected and withdrawn drug marketing applications. The FDA should follow suit and allow the American public to know when a drug is deemed unsafe or ineffective for a certain use. (shrink)

BackgroundThis study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form /informed consent form of a pediatric drug trial.MethodsA descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each item (...) in a questionnaire, by giving a rating scale from 1 to 5.ResultsA total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk–benefit aspects were perceived to be of most concerning items from both child participants’ and parents’ viewpoint. None of the items were considered ‘slightly important’ or lower by more than 20% of the respondents.ConclusionsFor pediatric drug trials, risk–benefit information should be made a salient feature of an IAF/icf. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/icf to better suit child participants’ and parents’ needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases. (shrink)

The article is focused on social stigma in informal social control of drug abuse. Social stigma is considered as the three related components: negative stereotypes, prejudices, and discrimination. The discrimination as a behavioral result of stigma manifests itself in capability deprivation, compulsion and segregation. According to this scheme, informal social control is shown on the example of the four Russian grassroots initiatives, which can be observed at the present time. They are implementing various approaches. As empirical data we used self-posted (...) materials of these initiatives on the Internet. The textual data was analyzed by combination of content analysis and critical discourse analysis. We conclude that the spectrum of social stigma in sphere of informal control is quite wide: from its correction to its significant gain. And the gain of social stigma could not be marked as negative unambiguously. In case of some grassroots initiatives the effectiveness and potency of social control may be also based on strengthening the social stigma of people who use alcohol and drugs. The last conclusion is connected with some data from other countries. (shrink)

This paper builds on previous work that investigated anticancer drugs as ‘informed materials’, i.e., substances that undergo an informational enrichment that situates them in a dense relational web of qualifications and measurements generated by clinical experiments and clinical trials. The paper analyzes the recent transformation of anticancer drugs from ‘informed’ to ‘informing material’. Briefly put: in the post-genomic era, anti-cancer drugs have become instruments for the production of new biological, pathological, and therapeutic insights into the underlying etiology (...) and evolution of cancer. Genomic platforms characterize individual patients’ tumors based on their mutational landscapes. As part of this new approach, drugs targeting specific mutations transcend informational enrichment to become tools for informing their targets, while also problematizing the very notion of a ‘target’. In other words, they have become tools for the exploration of cancer pathways and mechanisms. While several studies in the philosophy and history of biomedicine have called attention to the heuristic relevance and experimental use of drugs, few have investigated concrete instances of this role of drugs in clinical research. (shrink)

Assume this hypothetical situation: an American pharmaceutical company, Maxwell Fisch Pharmaceuticals, Inc., wishes to perform clinical trials involving a new antipsychotic medication, Klezac. Klezac is in its third phase of the clinical stage of the drug research process. Once the testing is complete, Maxwell plans to submit a New Drug Application, the official request to begin marketing Klezac, to the Food and Drug Administration. The new drug is expected to receive FDA approval in 2 or more years. The company decides (...) to shift its research and development activities to Z, a small, developing country. In doing so, Maxwell is following the course taken by numerous other drug companies who wish to take advantage of faster governmental approval in foreign sites and ensuing cheaper research costs. (shrink)

Bioethics has received important criticisms for its perceived privileging of biomedical authority with longstanding calls for greater recognition of the social, political, economic, historical, and...

In this study of advertisements appearing in medical periodicals and by direct mail advertising to general practitioners, Dr. Stimson, a sociologist, concludes that from what is intended to provide therapeutic information hardly any therapeutic information is provided. He reminds the reader of the safeguards which surround all drug advertising by law and by the code of practice of the Association of the British Pharmaceutical Industry but these safeguards do not appear to control real or potential sins of omission. (...) Frequently in these advertisements the literature relating to the drug is quoted but Dr. Stimson found that it was difficult to trace all the papers quoted in different types of medical library. (Some references quoted were to unpublished papers but surely the blame should be shared in this situation?) Dr. Stimson also gives a vivid and fascinating glimpse of what he calls the 'images and stereotypes' of the patients who, it is claimed, would benefit from the drug being advertised. Certainly most general practitioners must be aware that when they prescribe that image is displaced by an individual but the portrait gallery is indeed depressing. However, to balance these advertisements drug companies issue data sheets which must be more informative than advertisements and conform to regulations in their format. Unfortunately data sheets are only issued every 15 months whereas the 'average general practitioner is potentially exposed to 1,300 advertisements every month'. In other words, the data sheet and not the advertisement should be the guideline but it arrives too infrequently to offset the lack of therapeutic information contained in advertisements. (shrink)

In conclusion, then, we have tried to show that Drug actions can be predicted and described best on a probabilistic basis and information theory offers a suitable framework for such predictions. Drug actions are fundamentally of the all-or-none type involving the choice between two alternatives and these choises are therefore measurable by binary digits. Drug actions are not absolutely but only relatively specific and such specificity can be measured on the basis of information theory by an array of (...) suitable correlation data. Synergisms and antagonisms can best be explained and measured by considering them as intersymbol influences in communications. A theory of drug action based on information theory is more comprehensive and simpler than any theory based on the principles of classical physics and chemistry.However, these conclusions provide only the general basis for future detailed studies of various drug groups which will probably require the collaboration of chemists and pharmacologists as well as biological mathematicians to produce practical results.Der Verfasser bespricht die verschiedenen Probleme der Drogenwirkung und der Reizwirkung im allgemeinen und kommt zu den folgenden Schlussfolgerungen: Die Wirkung der Drogen kann am besten auf Grundlage der Wahrscheinlichkeitstheorie vorhergesagt und beschrieben werden und die mathematische Informationstheorie bietet einen befriedigenden Rahmen für solche Voraussagungen. Drogenwirkungen beruhen im Grunde genommen auf dem „Alles oder Nichts Prinzip”, d.h. sie beruhen auf einer Wahl zwischen zwei Alternativen und diese Wahlen sind als Logarithmen mit der Basis 2 messbar. Drogenwirkungen sind nicht absolut sondern nur relativ spezifisch und diese SpezifizitÄt kann auf Grundlage der Informationstheorie durch eine Matrize gernessen werden die eine Anordnung passender Korrelationsdaten enthÄlt. Synergismen und Antagonismen zwischen verschiedenen Substanzen können am besten dadurch erklÄrt und gemessen werden, dass man sie als gegenseitige Beeinflussung zwischen den eine Mitteilung bildenden Symbolen auffasst. Eine Theorie der Drogenwirkung auf der Informationstheorie basiert, ist umfassender und einfacher als irgend eine andere der die Prinzipien der klassischen Physik und Chemie zugrunde liegen.Jedoch bieten diese Schlussfolgerungen nur die allgemeine Grundlage für zukünftige detaillierte Studien der verschiedenen Drogenklassen und diese Studien werden die Mitarbeit der Chemiker, der Pharmakologen und der mathematisch eingestellten Biologen erfordern.L'auteur discute les divers aspects de l'action des drogues et des stimulus en général et arrive aux conclusions suivantes: La meilleure manière de prédire et de décrire l'action des drogues est celle qui se base sur la théorie des probabilités, et la théorie mathématique des informations et communications offre un cadre satisfaisant pour de telles prédictions. L'action des drogues est essentiellement du type „tout ou rien”, c'es-à-dire qu'un choix entre deux alternatives prend place et ces choix peuvent Être mesurés par des digits binaires. L'action des drogues est charactérisée non pas par une specificité absolue mais seulement relative et cette specificité peut Être mesurée sur base de la théorie des informations par une matrice contenant des données corrélatives convenables. Les synergismes et les antagonismes des substances agissant simultanément peuvent Être expliqués et mesurés en les considérant comme des influences, existantes entre les symboles constituant une communication. Une théorie pharmacodynamique basée sur la théorie des informations est plus compréhensive et plus simple qu'une théorie basée sur les principes de la physique et de la chimie classiques.Toutefois, ces conclusions ne fournissent que la base générale pour des études futures détaillées des diverses classes de substances pharmacologiques, et ces études demanderont la collaboration des chimistes, des pharmacologistes ainsi que des biologistes mathématiciens. (shrink)

Direct to consumer (DTC) advertising has attracted significant research attention, yet none has focused on empirical assessments of its overall impact on U.S. consumers nationally, and tying assessment to relevant behavioral outcomes. This paper addresses the ethical issue of DTC advertising providing a balance of product and risk information that is both understandable and believable, and contributes direction to those exploring this phenomenon.

I first became aware of bioethics in the spring of 1980. I had spent a thirty‐six‐hour shift shadowing a medical resident, and I was struck that many of the resident's decisions had ethical dimensions. The next day, I came across the Hastings Center Report, and I realized I wanted to explore ethical issues I found implicit in clinical care, even though I still wanted to become a pediatrician. In September 2019, when I attended my first meeting of the U.S. Food (...) and Drug Administration's Pediatric Advisory Committee, as a pediatric pulmonologist, I had the same sense of awe and curiosity that I had forty years ago. What had appeared initially as somewhat technical decisions about the regulation of drug labeling was suffused with ethical questions. The committee was asked to discuss possible changes to the labeling of two previously approved drugs. (shrink)

Recent research conducted in Australia shows that many oncologists withhold information about expensive unfunded drugs in what the authors of the study suggest is unacceptable medical paternalism. Surprised by the Australian results, we ran a version of the study in New Zealand and received very different results. While the percentages of clinicians who would prescribe the drugs described in the scenarios were very similar (73–99% in New Zealand and 72–94% in Australia depending on the scenario) the percentage (...) who would not discuss expensive unfunded drugs was substantially lower in New Zealand (6.4–11.1%) than it was in Australia (28–41%). This seems surprising given the substantial similarities between the two countries, and the extensive interaction between their medical professions. We use the contrast between the two studies to examine the generalisability of the Australian results, to identify influences on clinicians' decisions about what treatment information to give patients, and so the tendency towards medical paternalism and, more pragmatically, about how such decisions might be influenced. (shrink)

Direct to consumer advertising has attracted significant research attention, yet none has focused on empirical assessments of its overall impact on U.S. consumers nationally, and tying assessment to relevant behavioral outcomes. This paper addresses the ethical issue of DTC advertising providing a balance of product and risk information that is both understandable and believable, and contributes direction to those exploring this phenomenon.

Direct to consumer (DTC) advertising has attracted significant research attention, yet none has focused on empirical assessments of its overall impact on U.S. consumers nationally, and tying assessment to relevant behavioral outcomes. This paper addresses the ethical issue of DTC advertising providing a balance of product and risk information that is both understandable and believable, and contributes direction to those exploring this phenomenon.

Dr Peter Sjöstedt-H reviews Dr Andrew R. Gallimore's book, Alien Information Theory. -/- This was published on PsyPressUK on 13 June 2019.

The original version of this article unfortunately contained a mistake. Three entries are incorrect in the reference list. The corrected references are given below.

Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial (...) drug, if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists. Conclusion: Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a “fair” price; these views were less demanding than those of non-US subjects in other studies. However, our participants’ views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results. (shrink)

After witnessing extraordinary scientific and regulatory efforts to speed development of and access to new COVID-19 interventions, patients facing other serious diseases have begun to ask “where’s...

Aim Genetic research representative of the population is crucial to understanding the underlying causes of many diseases. In a prospective evaluation of informed consent we assessed the willingness of individuals of different ethnicities, gender and drug dependence history to participate in genetic studies in which their genetic sample could be shared with a repository at the National Institutes of Health. Methods Potential subjects were recruited from the general population through the use of flyers and referrals from previous participants and clinicians (...) with knowledge of our study. They could consent to 11 separate choices so that they could specify how and with whom their genetic sample could be shared. Rates of affirmative consent were then analysed by gender, ethnicity and drug dependence history. Results Of 1416 volunteers enrolled, 99.7% gave affirmative informed consent for studies of addiction conducted in our laboratory. No significant difference was found for participation in genetic studies conducted in our laboratory by gender, ethnicity or drug dependence history. Over all 11 questions, individuals with a history of drug use were more likely to agree to consent to participate in our study than were healthy volunteers. Conclusion A high percentage of each category of gender, ethnicity and drug history, gave affirmative consent at all levels. The level of detail in and the amount of time spent reviewing the informed consent, and a relationship of trust with the clinical investigator may contribute to this outcome. (shrink)

The US Food and Drug Administration (FDA) is fraught with controversies over the role of values and politics in regulatory science, especially with drugs in the realm of reproductive health. Philosophers and science studies scholars have investigated the ways in which social context shapes medical knowledge through value judgments, and feminist scholars and activists have criticized sexism and injustice in reproductive medicine. Nonetheless, there has been no systematic study of values and gender norms in FDA drug regulation. I focus (...) on three questions about values in regulatory science. First, how have societal values and gender norms shaped the way that the FDA regulates drugs in the realm of reproductive health, specifically with drug labels? Second, what are the ethical, epistemic, and social consequences of these influences on regulation for women and other marginalized groups? Third, which societal values and gender norms ought to influence drug regulation about reproductive health, and how ought this happen? Integrating philosophical analysis with historical archival research and in-depth interviews, I conduct three case studies of drug labeling about reproductive health: (1) the “drug fact” about the mechanism of the morning-after pill; (2) the package inserts for patients about the health risks of oral contraceptives; and (3) the special physician labels made for prescribing drugs to pregnant women. I identify three challenges for the FDA and suggest ways to reduce the influence of sexist values and facilitate feminist alternatives. First, across these cases, I have found that there are many ways in which other concerns in reproductive medicine (such as zygotic life, fetal health, and population control) have devalued women’s health. Second, both knowledge and ignorance xvi about their reproductive health have contributed to women’s oppression, especially poor women and women of color. Finally, by avoiding the epistemic dimensions of ethics, powerful, mostly male parties in medicine (such as doctors, pharmaceutical companies, and religious institutions) have misused “informed consent,” “religious freedom,” and “paternalism” for unethical purposes. For improvement, I suggest extracting sexist values and gender norms from regulatory science that cause epistemic injustices, and I point to success stories for reforming sexism with feminism at the FDA. (shrink)

Evidence suggests that research participants often fail to recall much of the information provided during the informed consent process. This study was conducted to determine the proportion of consent information recalled by drug court participants following a structured informed consent procedure and the neuropsychological factors that were related to recall. Eighty-five participants completed a standard informed consent procedure to participate in an ongoing research study, followed by a 17-item consent quiz and a brief neuropsychological battery 2 weeks later. (...) Participants performed within the normal range on most of the neuropsychological measures, although roughly one third showed deficits on measures of executive functioning. Participants failed to recall over 65% of the consent information within 2 weeks of entering the study, and their recall was significantly correlated with verbal IQ, drug problem severity, reading ability, memory, and attention. These factors may be useful in determining whether research participants require enhanced consent procedures. (shrink)

We often get evidence concerning the reliability of our own thinking about some particular matter. This “higher-order evidence” can come from the disagreement of others, or from information about our being subject to the effects of drugs, fatigue, emotional ties, implicit biases, etc. This paper examines some pros and cons of two fairly general models for accommodating higher-order evidence. The one that currently seems most promising also turns out to have the consequence that epistemic akrasia should occur more (...) frequently than is sometimes supposed. But it also helps us see why this might not be a bad thing. (shrink)

In our current era, a new rapidly spreading pandemic disease called coronavirus disease, caused by a virus identified as a novel coronavirus, is becoming a crucial threat for the whole world. Currently, the number of patients infected by the virus is expanding exponentially, but there is no commercially available COVID-19 medication for this pandemic. However, numerous antiviral drugs are utilized for the treatment of the COVID-19 disease. Identification of the appropriate antivirus medicine to treat the infection of COVID-19 is (...) still a complicated and uncertain decision. This study’s key objective is to develop a novel approach called _q_-rung orthopair probabilistic hesitant fuzzy rough set, which incorporates the _q_-rung orthopair fuzzy set, probabilistic hesitant fuzzy set, and rough set structures. New _q_-ROPHFR aggregation operators have been established: the _q_-ROPHFR Einstein weighted averaging operator and the _q_-ROPHFR Einstein weighted geometric operator. In this study, we explored some basic features of the developed operators. Afterward, to demonstrate the viability and feasibility of the established decision-making approach in real-world applications, a case study related to selecting drugs for COVID-19 pandemic is addressed. Furthermore, a comprehensive comparison with the _q_-rung orthopair probabilistic hesitant fuzzy rough TOPSIS technique is also presented to illustrate the benefits of the new framework. The obtained results confirm the reliability and effectiveness of the proposed approach for finding uncertainty in real-world decision-making. (shrink)

The profession of medicine is predicated upon an ethical mandate: first do no harm. However, critics charge that the medical profession’s culture and its public health mission are being undermined by the pharmaceutical industry’s wide-ranging influence. In this article, we analyze how drug firms influence psychiatric taxonomy and treatment guidelines such that these resources may serve commercial rather than public health interests. Moving beyond a conflict-ofinterest model, we use the conceptual and normative framework of institutional corruption to examine how organized (...) psychiatry’s dependence on drug firms has distorted science. We suggest that academic-industry relationships have led to the corruption of the evidence base upon which accurate diagnosis and sound treatment depend. We describe the current dependency corruption and argue that transparency alone is not a solution — and sometimes even produces iatrogenic effects. Furthermore, we argue that the corruption of the evidence base for diagnostic and practice guidelines renders obsolete the traditional informed consent process, and we offer suggestions for reforming this process. (shrink)

The possibility that industry is exerting an undue influence on the culture of medicine has profound implications for the profession's public health mission. Policy analysts, investigative journalists, researchers, and clinicians have questioned whether academic-industry relationships have had a corrupting effect on evidence-based medicine. Psychiatry has been at the heart of this epistemic and ethical crisis in medicine. This article examines how commercial entities, such as pharmaceutical companies, influence psychiatric taxonomy and treatment guidelines. Using the conceptual framework of institutional corruption, we (...) show that organized psychiatry's dependence on drug firms has led to a distortion of science. We describe the current dependency corruption and argue that transparency alone is not a solution. We conclude by taking the position that the corruption of the evidence base in diagnostic and practice guidelines has compromised the informed consent process, and we suggest strategies to address this problem. (shrink)

The legalization of cannabis in Canada instantiates principles of harm-reduction and safe supply. However, in-depth understanding of values at stake and attitudes toward legalization were not part of extensive democratic deliberation. Through a qualitative exploratory study, we undertook 48 semi-structured interviews with three Canadian stakeholder groups to explore opinions and values with respect to the legalization of cannabis: (1) members of the general public, (2) people with lived experience of addiction and (3) clinicians with experience treating patients with addiction. Across (...) all groups, participants tended to be in favor of legalization, but particular opinions rested on their viewpoint as stakeholders. Clinicians considered the way legalization would affect an individual’s health and its potential for increasing rates of addiction on a larger scale. People with lived experience of addiction cited personal autonomy more than other groups and stressed the need to have access to quality information to make truly informed decisions. Alternatively, members of the public considered legalization positive or negative in light of whether one’s addiction affected others. We elaborate on and discuss how scientific evidence about drug use impact values relates and how can different arguments play in democratic debates about legalization. (shrink)

Public policy tries to promote appropriate drug use by allowing firms to market drugs in interstate commerce only for uses that the Food and Drug Administration has found to be safe and effective. Because of their medical knowledge, physicians are authorized to prescribe drugs even for uses unapproved by the FDA. Nevertheless, physicians have relied on drug firms for information on appropriate prescribing despite the inherent tension between drug firm dissemination of information to promote sales and (...) rational prescribing. In the past, physicians often relied particularly on drug firm advertising for information on drug use. Today, physicians rely on drug firms to finance continuing medical education. A historical review reveals connections between these two different ways commercial interests have influenced the information that physicians receive and points the way to needed reforms. (shrink)

"Cluster randomized trials," in which groups of patients are randomly assigned to different therapeutic interventions, provide a powerful way of evaluating drugs. CRTs have not been widely used, in good part because of concerns about whether patients must give informed consent to participate in them. A better understanding of how CRTs fit into clinical practice resolves the concerns.

Computational drug repositioning has been proven as a promising and efficient strategy for discovering new uses from existing drugs. To achieve this goal, a number of computational methods have been proposed, which are based on different data sources of drugs and diseases. These methods approach the problem using either machine learning- or network-based models with an assumption that similar drugs can be used for similar diseases to identify new indications of drugs. Therefore, similarities between drugs (...) and between diseases are usually used as inputs. In addition, known drug-disease associations are also needed for the methods as prior information. It should be noted that those associations are still not well established due to the fact that many of marketed drugs have been withdrawn and this could affect the outcome of the methods. In this study, we propose a novel method named RLSDR to find new uses of drugs. More specifically, it relies on a semi-supervised learning model, Regularized Least Square, thus it does not require definition of non-drug-disease associations as previously proposed machine learning-based methods. In addition, the similarity between drugs measured by chemical structures of drug compounds and the similarity between diseases which share phenotypes can be represented in a form of either similarity network or similarity matrix as inputs of the method. Moreover, instead of using a gold-standard set of known drug-disease associations, we construct an artificial set of the associations based on known disease-gene and drug-target associations. Experiment results demonstrate that RLSDR achieves better prediction performance on the artificial set of drug-disease associations than that on the gold-standard ones in terms of area under the Receiver Operating Characteristic curve. In addition, it outperforms two representative network-based methods irrespective of the prior information of drug-disease associations. Novel indications for a number of drugs are also identified and validated by evidences from a different data resource. (shrink)

The aim of our paper is to analyze the position the psychedelic trance subculture takes on drug use and whether it applies to prescriptive regulatory systems on drug-taking. A qualitative field research strategy was adopted with the use of semi-structured interviews and participant observations. Actors at three levels of participation in the subculture (experts, long-term participants and newcomers to psychedelic trance parties) were interviewed. The results showed that the subculture distinguishes between tolerated and non-tolerated drugs. This distinction is different (...) from the mainstream paradigm. The subculture also has unwritten rules relating to the behavior expected of an intoxicatedperson. However, there is only limited potential for the subculture to enforce these standards and recognition that this represents a threat. Psychedelic trance stands out from other dance scenes in the use of specific drugs—hallucinogens—that dominate and inform its culture. (shrink)

Advocates of moral enhancement through pharmacological, genetic, or other direct interventions sometimes explicitly argue, or assume without argument, that traditional moral education and development is insufficient to bring about moral enhancement. Traditional moral education grounded in a Kohlbergian theory of moral development is indeed unsuitable for that task; however, the psychology of moral development and education has come a long way since then. Recent studies support the view that moral cognition is a higher-order process, unified at a functional level, and (...) that a specific moral faculty does not exist. It is more likely that moral cognition involves a number of different mechanisms, each connected to other cognitive and affective processes. Taking this evidence into account, we propose a novel, empirically informed approach to moral development and education, in children and adults, which is based on a cognitive-affective approach to moral dispositions. This is an interpretative approach that derives from the cognitive-affective personality system (Mischel and Shoda, 1995). This conception individuates moral dispositions by reference to the cognitive and affective processes that realise them. Conceived of in this way, moral dispositions influence an agent's behaviour when they interact with situational factors, such as mood or social context. Understanding moral dispositions in this way lays the groundwork for proposing a range of indirect methods of moral enhancement, techniques that promise similar results as direct interventions whilst posing fewer risks. (shrink)

As drug testing has become increasingly used to maximize corporate profits by minimizing the economic impact of employee substance abuse, numerous arguments have been advanced which draw the ethical justification for such testing into question, including the position that testing amounts to a violation of employee privacy by attempting to regulate an employee's behavior in her own home, outside the employer's legitimate sphere of control. This article first proposes that an employee's right to privacy is violated when personal information (...) is collected or used by the employer in a way which is irrelevant to the terms of employment. This article then argues that drug testing is relevant and therefore ethically justified within the terms of the employment agreement, and therefore does not amount to a violation of an employee's right to privacy. Arguments to the contrary, including the aforementioned appeal to the employer's limited sphere of control, do not account for reasonable constraints on employee privacy which are intrinsic to the demands of the workplace and implicit in the terms of the employment contract. (shrink)

Drug promotion should be evaluated according to its impact on health, access to information, informed consent, and wealth. Drug promotion currently does more harm than good to each of these objectives because it is usually misleading. This is a systemic problem. Whilst improved regulation and education will address it to some degree, major reforms to payment systems for drug companies and doctors are also required. Until all these systemic reforms can be put in place, the best policy option is (...) to ban the promotion of drugs to doctors and the public. Consequently, pending major reforms, it is appropriate for governments to restrict drug promotion as much as is politically achievable. (shrink)

We commend Redish et al. for the progress they have made in bringing a measure of theoretical order to the processes that underlie drug addiction. However, incorporating information about situations in which drug users do not exhibit faulty decision-making into the theory would greatly enhance its generality and practical value. This commentary draws attention to the relevant human substance abuse literature.

This article investigates the distribution of power in Poland’s drug reimbursement policy in the early 2000s. We examine competing theoretical expectations suggested by neopluralism, historical institutionalism, corporate domination, and clique theory of the post-communist state, using data from a purposive sample of 109 semi-structured interviews and documentary sources. We have four concrete findings. First, we uncovered rapid growth in budgetary spending on expensive drugs for narrow groups of patients. Second, to achieve these favorable policy outcomes drug companies employed two (...) prevalent methods of lobbying: informal persuasion of key members of local cliques and endorsements expressed by patient organizations acting as seemingly independent “third parties.” Third, medical experts were co-opted by multinational drug companies because they relied on these firms for scientific and financial resources that were crucial for their professional success. Finally, there was one-way social mobility from the state to the pharmaceutical sector, not the “revolving door” pattern familiar from advanced capitalist countries, with deleterious consequences for state capacity. Overall, the data best supported a combination of corporate domination and clique theory: drug reimbursement in Poland was dominated by Western multinationals in collaboration with domestically based cliques. (shrink)

Biology incorporated into other disciplines is often distorted, alarmingly so in some areas of medicine. Together with other forms of bias, this may have detrimental effects for patients depending on medical research for their health. A case study concerning omeprazole (Losec), one of the acid-suppressive drugs against gastric ulcers, and NSAIDs, non-steroid anti-inflammatory drugs, confirms that distorted biology together with biased health care policies foster disasters in current biomedicine and medical practice. In our country, The Netherlands, omeprazole is (...) presumably the most commonly used medication. NSAIDs are also used in large quantities, increasingly since they have become available as analgesic over-the-counter drugs. Unofficial and official sources tend to inform the general public that the drugs promote human health. We argue that their being used on a massive scale is actually a medical disaster. The health of many patients would be served better if the drugs they take were replaced by proper forms of diet, but the pharmaceutical industry, the most potent force affecting medication policies, appears to prevent a shift in the balance from over-medicalization towards healthy life styles. The shift should come from government agencies responsible for regulation in the medication market. Policies of these agencies are now a dismal failure. (shrink)

While the world rushed to develop treatments for COVID-19, some turned hopefully to drug repurposing. However, little study has addressed issues of drug repurposing in emergency situations from a broader perspective, taking into account the social and ethical ramifications. When drug repurposing is employed in emergency situations, the fairness of resource distribution becomes an issue that requires careful ethical consideration.This paper examines the drug repurposing in emergency situations focusing on the fairness using Japanese cases. Ethical issues under these circumstances addressed (...) by the authors include: maintaining the evidence level, integrity of clinical research ethics, and voluntary consent by original indication patients. In order to address these issues, they argue that rapid accumulation of ethically and scientifically valid evidence is required, as is obtaining information on resource quantity. (shrink)

The term “off-label drug use” refers to drugs that have not yet acquired “approved” status or drugs that have acquired “approved” status but are used with a different dosage, route, or administration method other than that for which the drug has been approved. In New Zealand, the Medicines Act 1981 specifically allows for off-label drug use. However, this authority is limited by the Health and Disability Commissioner Regulations 1996 and the common law, which require that off-label drug use (...) is of an acceptable standard, that the patient should be fully informed, and that the patient should give informed consent. Off-label drug use is an important issue because the current law provides medical practitioners very wide discretionary power, without providing clarification for what is required of the practitioner in exercising his or her discretion in prescribing off-label. This paper discusses possible solutions to this issue, for example, establishing protocol for off-label use, an electronic database of off-label use, and the amendment of legal provisions. (shrink)

Malaria is a disease of developing countries whose local health services do not have the time, resources or personnel to mount studies of drugs or vaccines without the collaboration and technology of western investigators. This investigative collaboration requires a unique bridging of cultural differences with respect to human investigation. The following debate, sponsored by The Institute of Medicine and The American Society of Tropical Medicine and Hygiene, raises questions concerning the conduct of trans-cultural clinical malaria research. Specific questions are (...) raised about the difficulties of informed consent in different cultural settings and whether there is any role for community involvement. Discussants debate whether drug and vaccine trials not approved in an industrialised country are ever defensible if performed in a third-world setting. Potential conflicting priorities between investigators are discussed and ideas regarding conflict resolution are offered. (shrink)

Abstract:Although the idea of intellectual property (IP) rights—proprietary rights to what one invents, writes, paints, composes or creates—is firmly embedded in Western thinking, these rights are now being challenged across the globe in a number of areas. This paper will focus on one of these challenges: government-sanctioned copying of patented drugs without permission or license of the patent owner in the name of national security, in health emergencies, or life-threatening epidemics. After discussing standard rights-based and utilitarian arguments defending intellectual (...) property we will present another model. IP is almost always a result of a long history of scientific or technological development and numbers of networks of creativity, not the act of a single person or a group of people at one moment in time. Thus thinking about and evaluating IP requires thinking about IP as shared rights. A network approach to IP challenges a traditional model of IP. It follows that the owner of those rights has some obligations to share that information or its outcomes. If that conclusion is applied to the distribution of antiretroviral drugs, what pharmaceutical companies are ethically required to do to increase access to these medicines in the developing world will have to be reanalyzed from a more systemic perspective. (shrink)