Drugs

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)

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.

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)

"Before they were 'junkies,' they were kids." The words appear on a poster, beneath a montage of photographs of children and the text: "Save Insite." Insite, located in Vancouver, Canada, is North America's first and only supervised injection facility (SIF). At Insite, people who use injection drugs can inject previously obtained drugs, such as heroin and cocaine, under medical supervision, using sterile equipment provided by this government-run facility. Opened under the auspices of a three-year exemption from federal drug laws in (...) 2003, the site was initially the focus of a research study aiming to determine whether such a service would be effective in reducing the harms associated with injection drug use. After .. (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 article offers a critical contribution to the debate on a problematic ‘type’ of injecting drug use referred to as needle fixation. At the heart of this debate, is a questioning of the existence, prevalence and usefulness of the needle fixation concept for academics and drug treatment practitioners working with injecting drug users. The aim of this article is to extend and develop this discussion by examining the historical conditions of the needle fixation discourse. Drawing upon Michel Foucault’s concept of (...) governmentality, it uses primary and secondary sources from the 19th century to the present to trace the historical trajectory of the problematic relationship between the injecting drug user, the syringe and truth. By reconceptualizing needle fixation as a technology of government, this article will argue that needle fixation can be seen to be incompatible with contemporary rationalities found in treatment policy and practice, suggesting that we have moved beyond needle fixation as a way of governing injecting drug use and into the domain of risk management. Beyond revealing this tension, the article highlights new lines that are currently being drawn between the injecting drug user, the syringe and truth from the field of neuroscience and the risk-management potential of psychopharmacology. (shrink)

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 merger of GlaxoWellcome and SmithKlineBeecham in 2000 created the world’s second largest pharmaceutical company, GlaxoSmithKline. GSK also became the world’s leader in the provision of drugs to treat the three most critical diseases in the developing world: HIV/AIDS, malaria and tuberculosis. In addition to merger related strategy and restructuring activities, the company finds itself having to respond to pressures to increase access to these essential medicines in developing countries, including the possibility of major reductions in price. How should GSK (...) respond to these pressures? (shrink)

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)