Drugs

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 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)

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)

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)

Rational drug design is a method for developing new pharmaceuticals that typically involves the elucidation of fundamental physiological mechanisms. It thus combines the quest for a scientific understanding of natural phenomena with the design of useful technology and hence integrates epistemic and practical aims of research and development. Case studies of the rational design of the cardiovascular drugs propranolol, captopril and losartan provide insights into characteristics and conditions of this integration. Rational drug design became possible in the 1950s when theoretical (...) knowledge of drug-target interaction and experimental drug testing could interlock in cycles of mutual advancement. The integration does not, however, diminish the importance of basic research for pharmaceutical development. Rather, it can be shown that still in the 1990s, linear processes of innovation and the close combination of practical and epistemic work were interdependent. (shrink)

In the United States today, the use or possession of many drugs is a criminal offense. Can these criminal laws be justified? What are the best reasons to punish or not to punish drug users? These are the fundamental issues debated in this book by two prominent philosophers of law. Douglas Husak argues in favor of drug decriminalization, by clarifying the meaning of crucial terms, such as legalize, decriminalize, and drugs; and by identifying the standards by which alternative drug policies (...) should be assessed. He critically examines the reasons typically offered in favor of our current approach and explains why decriminalization is preferable. Peter de Marneffe argues against drug legalization, demonstrating why drug prohibition, especially the prohibition of heroin, is necessary to protect young people from self-destructive drug use. If the empirical assumptions of this argument are sound, he reasons, drug prohibition is perfectly compatible with our rights to liberty. (shrink)

Wealthy countries are increasingly experiencing shortages of a wide range of generic drugs. These shortages are creating substantial harms for patients and problems for health systems. Despite recurring shortages and industry investigations, the nature and character of the drug shortage crisis remain the same: shortage drugs provide slim or negative profit margins, generic drug companies are reluctant to invest in quality improvements, and manufacturers are finding more reason to exit shortage drug markets. This thesis catalogues and explores these and other (...) causes of the problem. The proposals that have been made to address the problem at best merely mitigate it, and only target the systemic manufacturing and regulatory issues that immediately precede a shortage. The targeted issues are only symptoms, and not the root causes of drug shortages. In order to properly address the drug shortage crisis and minimize these symptoms, solutions must acknowledge the underlying economic mechanisms that make the crisis a reality. This thesis argues that, specifically, tackling drug shortages requires that one examine the economic pressures exerted on drug manufacturers by the Medicare Modernization Act’s Average-­Sales-­Price reimbursement system, and the practices and behaviours of group purchasing organizations. To understand these pressures and effects on manufacturers is to uncover some of the root economic causes of the drug shortage crisis that give rise to the manufacturing issues immediately preceding drug shortages. (shrink)

Would a “medicalization” of love be a “good” or “bad” form of medicalization? In discussing this question, Earp, Sandberg, and Savulescu primarily focus on the potential positive and negative consequences of turning love into a medical issue. But it can also be asked whether there is something intrinsically regrettable about medicalizing love. It is argued here that the medicalization of love can be seen as an “evaluative category mistake”: it treats a core human value as if it were mainly a (...) means to other ends . It is also argued that Earp et al’s closing argument can be seen as involving another evaluative category mistake: it treats an object of desire and practical interest as if it mainly were an object of scientific contemplation and theoretical interest. It is concluded that, to relate love to health and well-being in a more satisfying way, we should construe the latter two in broader ways, whereby love is itself a component or element of human flourishing. (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)

Pharmaceutical companies have long focused their marketing strategies on getting doctors to write more prescriptions. But they lose billions in potential sales when patients do not take their prescribed drugs. Getting patients to “adhere” to drug therapies that have unpleasant side effects and questionable efficacy requires more than mere ad campaigns urging patients to talk to their doctors. It requires changing patients' beliefs and attitudes about their medications through repeated contact from people patients trust. Since patients do not trust drug (...) companies, these companies are delivering their marketing messages through nurses, pharmacists, and even other patients — leveraging patients' trust in these intermediaries to persuade them to consume more brand name drugs. Armed with the premise that better adherence improves patients' health, drug companies justify manipulating patients by reframing reasonable decisions to decline therapy as pathological, and promote brand loyalty in the guise of offering medical care. (shrink)