Drugs

How do our brains make choices? How do factors such as Alzheimer's or depression impair decision-making? Presenting the latest research on 'hot' and 'cold' decision-making, Barbara Sahakian and Jamie Nicole LaBuzetta look at the therapeutic smart drugs now available, and raise concerns about their unregulated use to enhance mental performance.

The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article investigates the regulation (...) of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in-depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis-à-vis their stated goals and objectives. (shrink)

The increasing use of opioid treatment agreements has prompted debate within the medical community about ethical challenges with respect to their implementation. The focus of debate is usually on the efficacy of OTAs at reducing opioid misuse, how OTAs may undermine trust between physicians and patients and the potential coercive nature of requiring patients to sign such agreements as a condition for receiving pain care. An important consideration missing from these conversations is the potential for racial bias in the current (...) way that OTAs are incorporated into clinical practice and in the amount of physician discretion that current opioid guidelines support. While the use of OTAs has become mandatory in some states for certain classes of patients, physicians are still afforded great leeway in how these OTAs are implemented in clinical practice and how their terms should be enforced. This paper uses the guidelines provided for OTA implementation by the states of Indiana and Pennsylvania as case studies in order to argue that giving physicians certain kinds of discretion may exacerbate racial health disparities. This problem cannot simply be addressed by minimising physician discretion in general, but rather by providing mechanisms to hold physicians accountable for how they treat patients on long-term opioid therapy to ensure that such treatment is equitable. There are no data in this work. (shrink)

Medicines and medical devices containing animal-derived ingredients are frequently used on patients without their informed consent, despite a significant proportion of patients wanting to know if an animal-derived product is going to be used in their care. Here, I outline three arguments for why this practice is wrong. First, I argue that using animal-derived medical products on patients without their informed consent undermines respect for their autonomy. Second, it risks causing nontrivial psychological harm. Third, it is morally inconsistent to respect (...) patients’ dietary preferences and then use animal-derived medicines or medical devices on them without their informed consent. I then address several anticipated objections and conclude that the continued failure to address this issue is an ethical blind spot that warrants applying the principles of respect for autonomy and informed consent consistently. There are no data in this work. (shrink)

Tamamlayıcı ve alternatif tıp (TAT) uygulamaları temel tıbbi tedaviye ek ya da temel tıbbi tedavinin yerine kullanılan, uygulamaları genelde konvansiyonel tıp tarafından tedavi olarak kabul edilmeyen çeşitli tıbbi ve sağlık bakım sistemi, pratikleri ve ürünleri olarak tanımlanmaktadır (Hossein et al., 2014, Amira ve Okubadejo, 2007; National Institutes of Health [NIH], 2018). TAT konusunda yapılan araştırmalar Afrika, Asya ve Latin Amerika gibi gelişmemiş ya da gelişmekte olan ülkelerde hastaların bazı tedavi ihtiyaçlarını karşılamak amacıyla geleneksel uygulamalara başvurmaları doğrultusunda geleneksel tıp teriminin tamamlayıcı (...) ve alternatif tıpa karşılık gelecek şekilde kullanıldığını da göstermektedir. (shrink)

Despite their centrality to medicine, drugs are not easily defined. We introduce two desiderata for a basic definition of medical drugs. It should: (i) capture everything considered to be a drug in medical contexts and (ii) rule out anything that is not considered to be a drug. After canvassing a range of options, we find that no single definition of drugs can satisfy both desiderata. We conclude with three responses to our exploration of the drug concept: maintain a monistic concept, (...) or choose one of two pluralistic outcomes. Notably, the distinction between drugs and other substances is placed under pressure by the most plausible of the options available. (shrink)

This article argues that performance enhancing drugs ought to be allowed across all elite sporting competitions for athletes over the age of 16 so long as consuming them does not pose a significant risk to their health. I begin with a brief explanation of the current state of PED use in professional sports before assessing the prospect of allowing PEDs by three widely accepted measures of ethical merit: well-being, autonomy, and justice. I end with a critique of the World Anti-Doping (...) Agency's criteria for banning PEDs, concluding that allowing athletes to use PEDs is a superior alternative to the current prohibitive approach. (shrink)

Intellectuals such as William James and Aldous Huxley have thought it possible to develop a technique to apply to this world the mystical-type insights gained during drug-enabled experiences. Particularly, Huxley claimed that the visionary experience triggered by psychedelics could help us rethink our relationship with technology and promote a much-needed cultural change. In this article, we explore this hypothesis. To do so, we build a philosophical framework based on Günther Anders's philosophy of technique, presenting human beings as morally blind when (...) facing technological development. Mystical experiences are then proposed as a means to improve our moral faculties—and psychedelic drugs as tools to enable them. We finally explore the empirical feasibility of such a hypothesis by thoroughly reviewing the recent scientific literature on the nature of the psychedelic experience, concluding that the long-term effects in the personality domain openness and in nature relatedness point to the emergence of a morally improved agent, thus providing substance to an application of mysticism. (shrink)

In late May 1984, Irish citizens were perturbed to hear that a thirty-one year old man died while participating, as a paid volunteer, in a clinical drug trial at the Institute of Clinical Pharmacology in Dublin. At the inquest, held in September 1984, the State Pathologist, Dr John Harbison, affirmed that the cause of death was the reaction of the trial drug Eproxindine 4/0091 with a major tranquillizer which had been given less than fifteen hours earlier as part of regular (...) treatment for a psychiatric disorder. The mixture of the two drugs, he went on to say, increased their effect by between twenty and thirty times their normal strength, and the volunteer had died of cardiac depression. (shrink)

The contributions of adolescent and parent perspectives to ethical planning of survey research on youth drug use and suicide behaviors are highlighted through an empirical examination of 322 7th-12th graders' and 160 parents' opinions on questions related to 4 ethical dimensions of survey research practice: evaluating research risks and benefits, establishing guardian permission requirements, developing confidentiality and disclosure policies, and using cash incentives for recruitment. Generational and ethnic variation in response to questionnaire items developed from discussions within adolescent and parent (...) focus groups are described. The article concludes with a discussion of the potential contributions and challenges of adolescent and parent perspectives for planning scientifically valid and ethically responsible youth risk survey research. (shrink)

The lingering controversy concerning the usefulness and safety of antidepressants for children and adolescents is likely to confuse clinicians. Recent papers perpetuate the claim that antidepressants are shown to be safe and effective in randomised controlled trials. Others claim that antidepressants have been shown to prevent suicides. In this editorial we address the manipulation of outcomes that result from academics’ alliance with industry. We explain how industry and key opinion leaders have distorted the clinician’s perception of the safety and usefulness (...) of antidepressants for the treatment of depression in children and adolescents through publication bias, poor methodology, and selective reporting. (shrink)

This case study reports an instance of SmithKline Beecham's behind-the-scenes ghostwriting a letter to the editor in a medical journal article in the name of an academic physician. In order to respond to criticism that paroxetine caused severe withdrawal effects, SmithKline Beecham's marketing department hired a PR firm to ghostwrite three separate letters to spin a favorable impression of paroxetine vs fluoxetine and published one in the Journal of Clinical Psychiatry.

The goal of this paper is to expose the research misconduct of pharmaceutical industry-sponsored clinical trials via three short case studies of corrupted psychiatric trials that were conducted in the United States. We discuss the common elements that enable the misrepresentation of clinical trial results including ghostwriting for medical journals, the role of key opinion leaders as co-conspirators with the pharmaceutical industry and the complicity of top medical journals in failing to uphold standards of science and peer review. We conclude (...) that the corruption of industry-sponsored clinical trials is one of the major obstacles facing evidence-based medicine. (shrink)

This paper is a deconstruction of a ghostwritten report of a randomized, double-blind, placebo-controlled efficacy and safety trial of citalopram in depressed children and adolescents conducted in the United States. Court documents revealed that protocol-specified outcome measures showed no statistically significant difference between citalopram and placebo. However, the published article concluded that citalopram was safe and significantly more efficacious than placebo for children and adolescents, with possible adverse effects on patient safety.

In the wake of several highly publicized lawsuits over drugs recalled for safety – most notably, Vioxx and Paxil – the Food and Drug Administration and the pharmaceutical industry have faced increasingly intense public scrutiny over the drug testing and approval process. Critics blame the FDA's shorter pre-market approval process that has resulted from the enactment of the Prescription Drug User Fee Act, which effected, among other changes, an increased number of reviewers, a higher review load for each reviewer, and (...) the implementation of “user fees” from companies submitting drugs for review. While many have posited that the lack of safety in some FDA-approved drugs was caused by the enactment of PDUFA, the results of a recent study from the Tufts Center for the Study of Drug Development have indicated that there is no statistically significant correlation between the number of drugs recalled for safety and the enactment of PDUFA. (shrink)

Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying (...) skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. (shrink)

In many jurisdictions, an offender’s remorse is considered to be a relevant factor to take into account in mitigation at sentencing. The growing philosophical interest in the use of neurointerventions in criminal justice raises an important question about such remorse-based mitigation: to what extent should technologically facilitated remorse be honoured such that it is permitted the same penal significance as standard instances of remorse? To motivate this question, we begin by sketching a tripartite account of remorse that distinguishes cognitive, affective (...) and motivational elements of remorse. We then describe a number of neurointerventions that might plausibly be used to enhance abilities that are relevant to these different elements of remorse. Having described what we term the ‘moral value’ view of the justification of remorse-based mitigation, we then consider whether using neurointerventions to facilitate remorse would undermine its moral value, and thus make it inappropriate to honour such remorse in the criminal justice system. We respond to this question by claiming that the form of moral understanding that is incorporated into a genuinely remorseful response grounds remorse’s moral value. In view of this claim, we conclude by arguing that neurointerventions need not undermine remorse’s moral value on this approach, and that the remorse that such interventions might facilitate could also be authentic to the recipient of the neurointerventions that we discuss. (shrink)

This article examines the case of Insite, North America’s only supervised injection facility, to consider the relationship between dependence, relational autonomy, and vulnerability. At state-funded Insite, users inject illicit drugs under medical supervision. By conceiving of Insite as a health-care facility and addiction as disease, advocates evoke a shared sense of vulnerability among the nonusing public and users, garnering considerable support for the site. Through Insite, the state responds to vulnerability by reshaping the meaning of dependence and conferring recognition upon (...) users, in turn fostering users’ autonomy. However, the medicalized discourse surrounding Insite may obscure drug users’ vulnerabilities emerging not from “disease,” but from stigma and criminalization. Vulnerability analysis must emphasize not merely a naturalized conception of vulnerability, but the socially constructed nature of human beings’ experiences of vulnerability. (shrink)

Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the (...) regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free-riding’ encounters some important problems: Neither legitimize excluding all others. (shrink)

This book critically explores and analyses the scientific and ethical debates surrounding cognitive enhancers. Including contributions from neuroscientists, neuropsychopharmacologists, ethicists, philosophers, public health professionals, and policy researchers, the book offers a multidisciplinary, critical consideration of this topic.

The relationship between the physician and the pharmaceutical detail man is discussed. Specific emphasis is given to an analysis of the ethical implications that this relationship has for patient care.

The (B) case summarizes GSK’s response to pressures to increase access to essential medicines in developing countries and subsequent developments.

In perpetuating and exacerbating restricted access to essential medicines, current trade-related intellectual property rules on medicines may violate core human rights to health and medicines. In this light, there should be serious questions about their necessity, and their justification should be critically assessed from the perspective of human rights standards.

In Africa fewer than 50,000 people—less than 2 percent of the people in need—currently receive ARV therapy. These facts have elicited strongly divergent reactions, and views about the appropriate response to this crisis have varied widely.

The purpose of the study is to identify perception of doctors and pharmacists on drug promotion practices adopted by pharmaceutical representatives. Material and Methods: A total of 72 pharmacists and 65 doctors responded to a questionnaire about their perceptions on drug promotion practices by pharmaceutical representatives, both in relation to pharmacists and doctors in the relationship. Variables such as age, work environment, seniority, were considered. Of all pharmacists who responded to the questionnaire, a percentage of 47.8% say they have no (...) information about the existence of an ethical code of the pharmaceutical company, and 52.1% believe that there is such a code. Pharmacists estimated that over 75% of pharmaceutical representatives promote clearly the products; the information provided is accurate, complete and balanced enough to compete. Meanwhile, the percent estimated by doctors is 73%. Informal gifts are more often offered to doctors, in both category’s opinion. Conclusion: medical doctors have a more positive evaluation about pharmaceutical representative’s attitude than pharmacists. (shrink)

From the title, Deadly Medicines and Organised Crime: How Big Pharma has Corrupted Healthcare, Peter Gøtzsche makes the thesis of his book very clear. Not only does the pharmaceutical industry contribute to detrimental health outcomes through biased research, deceptive marketing, and disease mongering, but the industry’s business model meets the criteria of an organized criminal operation. Gøtzsche argues for this in two parts. First, he defines organized crime by drawing upon the United States Organized Crime Control Act of 1970, the (...) centerpiece of which is the Racketeer Influenced and Corrupt Organizations Act. RICO prohibits deriving income from a pattern of racketeering... (shrink)

Profoundly important ethical and political controversies turn on the question of whether biological life is an essential aspect of a human person, or only an extrinsic instrument. Lee and George argue that human beings are physical, animal organisms - albeit essentially rational and free - and examine the implications of this understanding of human beings for some of the most controversial issues in contemporary ethics and politics. The authors argue that human beings are animal organisms and that their personal identity (...) across time consists in the persistence of the animal organisms they are; they also argue that human beings are essentially rational and free and that there is a radical difference between human beings and other animals; criticize hedonism and hedonistic drug-taking; present detailed defenses of the prolife positions on abortion and euthanasia; and defend the traditional moral position on marriage and sexual acts. (shrink)

A much-debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics “pharmascolds.” Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these questions in (...) mind. Deadly Medicine and Organized Crime, by Peter Gøtzsche, Bad Pharma, by Ben Goldacre, and Good Pharma, by Donald Light and Antonio Maturo, all situate their critical assessments in high-income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative. (shrink)

The best studies on the relationship between pharmaceutical corporations and medicine have recognized that it is an ambiguous one. Yet most scholarship has pursued a simpler, more saleable narrative in which pharma is a scheming villain and medicine its maidenly victim. In this article, I argue that such crude moral framing blunts understanding of the murky realities of medicine's relationship with pharma and, in consequence, holds back reform. My goal is to put matters right in respect to one critical area (...) of scholarly interest, the medical journal publication. Pharma relies on peer advocacy to sell its wares to prescribing doctors. This is an arrangement in which clinicians’ qualified colleagues, including “key opinion leaders,” are recruited by pharmaceutical corporations and marketing agencies to deliver commercially expedient content to their professional fellows. Precisely how this practice works in the setting of publications is not well understood because ethicists studying the problem have made too much of the narrative of corporate villainy and medical victimhood. Accordingly, criticism of industry publications has been preoccupied with the crudely dishonest practices of ghostwriting, ghost authorship, and “ghost management,” vices condemned as “dirty little secrets” perpetrated from “behind the scenes” with the connivance of academic “shills” or “guest authors,” in contempt of standards set by the International Committee of Medical Journal Editors. This account is appealing, and yet it is wrong or, at the very least, seriously incomplete, with only limited relevance to the actualities of contemporary industry practices. In truth, many commercial publications are not developed in secret but fashioned within a culture of open collaboration, where academic authors make substantial, independent contributions; pharmaceutical companies are showcased rather than hidden; and medicine's editorial standards assist rather than impede the workings of commerce. (shrink)

A central goal in regulating direct-to-consumer advertising of prescription pharmaceuticals is to ensure that explicit drug claims are truthful. Yet imagery can also alter viewer attitudes, and the degree to which this occurs in DTCA is uncertain. Addressing this data gap, we provide evidence that positive feelings produced by images can promote favourable beliefs about pharmaceuticals. We had participants view a fictitious anti-influenza drug paired with unrelated images that elicited either positive, neutral or negative feelings. Participants who viewed positive images (...) rated the influenza drug as significantly more effective, safe, and beneficial than did participants who viewed negative images. This effect, known as evaluative conditioning, is well described in experimental social psychology but has not previously been shown with pharmaceuticals. We discuss how evaluative conditioning in DTCA may compromise viewer autonomy, and canvass possible regulatory responses. (shrink)

The Constitution of the World Health Organization affirms that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being.” The Universal Declaration of Human Rights lays the foundations for the international framework for the right to health. This human right is now codified in numerous national constitutions, as well as legally binding international human rights treaties, such as the International Covenant on Economic, Social and Cultural Rights.Although medical care and access to (...) medicines are vital features of the right to health, almost two billion people lack access to essential medicines, leading to immense avoidable suffering. Improving access to essential medicines could save 10 million lives each year, four million of them in Africa and South-East Asia alone. Gross inequity is a shocking feature of the world pharmaceutical situation. (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)

Approximately two billion people lack access to medicines globally. People living with HIV, cancer patients, those suffering from tuberculosis or malaria, and other populations in desperate need of life-saving medicines are increasingly unable to access existing preventative, curative, and life-prolonging treatments. In many cases, treatment may be unavailable or inaccessible for even some of the most common and readily treatable health concerns, such as hypertension. In the developing world, many of the factors that contribute to making the world’s most vulnerable (...) and marginalized populations particularly susceptible to illness also operate to restrict their access to medicines. As a result of dramatic economic inequities and widespread poverty, it is not profitable for most originator pharmaceutical companies to develop new medicines for sale in developing markets or to lower the cost of existing drugs so that they are affordable for the majority of these populations. (shrink)