Following a Canadian Supreme Court ruling invalidating an absolute prohibition on physician assisted dying, two reports and several commentators have recommended that the Canadian criminal law allow medical assistance in dying (MAID) for persons with a diagnosis of mental disorder. A key element in this process is that the person requesting MAID be deemed to have the ‘mental capacity’ or ‘mental competence’ to consent to that option. In this context, mental capacity and mental competence refer to ‘decision-making capacity’, which is (...) a distinct area of clinical study and research in the theory of informed consent. The purpose of this discussion is to bring several controversial but insufficiently acknowledged problems associated with decision-making capacity to the forefront of the proposed extension of MAID to persons diagnosed with mental disorders. Open-ended access to MAID by persons who suffer from mental health conditions already exists in Belgium and the Netherlands, where the issues raised here are equally relevant. In this paper, we highlight the serious limitations of relying on capacity assessments to allow access to MAID/Euthanasia. (shrink)
(2002). Avoiding a Jekyll-And-Hyde Approach to the Ethics of Clinical Research and Practice. The American Journal of Bioethics: Vol. 2, No. 2, pp. 14-17.
Industry control over the production and distribution of pharmaceutical safety and efficacy data has become a serious public health and health care funding concern. Various recent scandals, several involving the use of flawed representations of scientific data in the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes why this is a human rights concern and what difference a human rights analysis can make. The paper first identifies the challenges associated with the current knowledge (...) deficit. It then discusses, based on an analysis of case law, how various human rights associated interests can be invoked to support the claim that states have an obligation to actively contribute to independent knowledge governance, for example through ensuring clinical trials transparency. The paper further discusses a conceptual use of human rights, as a methodology which requires a comprehensive analysis of the different interwoven historical, economic, cultural, and social factors that contribute to the problem. Such an analysis reveals that historically grown drug regulations have, in fact, contributed directly to industry control over pharmaceutical knowledge production. This type of finding should inform needed reforms of drug regulation. The paper ends with a recommendation for a comprehensive global response to the problem of pharmaceutical knowledge governance. (shrink)
In recent years, the development process of pharmaceuticals, medical devices, and related products and the overall market of these products have become increasingly global. This paper discusses the need for better governance of one aspect of this market: the production, distribution, and use of pharmaceutical knowledge. Various controversies, some of which will be described in this paper, highlight how industry control over pharmaceutical data production has resulted in very serious threats to public health. Different practices and regulatory fields that affect (...) what I will refer to in this paper as “pharmaceutical knowledge production” are all too often artificially separated and dealt with in isolation, which seriously affects the quality of the available information on the safety and effectiveness of products. I will examine here how a human rights-based approach should inspire us to look more carefully not only at the significant human rights-related interests that are at stake, but also at the relations between the different interwoven regulatory, cultural, and social factors and how these play out at the various stages of knowledge production. (shrink)
A growing number of clinical trials use invasive research procedures to obtain tissue for disease screening and to monitor the effects of drugs. These procedures can be ethically contentious because they often have neither therapeutic nor diagnostic value, and because research participants may not realize this, which could compromise the validity of their consent to the procedure. In the first section of this paper, we describe the burdens, risks, and benefits associated with certain common invasive, nondiagnostic research procedures. We next (...) offer a series of arguments about the general properties of a valid consent for such procedures, and we close by examining what is currently known about consent quality for invasive research procedures when measured against the standards laid out in the second section. We conclude that there is little evidence to either confirm or dispel concerns about participants’ consent quality for protocols involving invasive, nondiagnostic research procedures. (shrink)
Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this is repeated over and over again; finally it can be calculated in advance, and it becomes part of the ceremony.–Franz KaflaFor more than two decades, significant controversies have been brewing over the efficacy and safety of Selective Serotonin Reuptake Inhibitors and other treatments for depression, and also over the expansion of their use for the treatment of a variety of other conditions. These controversies (...) culminated, in June 2004, with alawsuit intended by Eliot Spitzer, Attorney General of the State of New York. The lawsuit accused pharmaceutical giant GlaxoSmith-Kline of “repeated and persistent fraud by misrepresentation, concealing and otherwise failing to disclose to physicians information in its control concerning the safety and effectiveness of its antidepressant medication paroxetine” in treating children and adolescents suffering from depression. (shrink)
Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this is repeated over and over again; finally it can be calculated in advance, and it becomes part of the ceremony.–Franz KaflaFor more than two decades, significant controversies have been brewing over the efficacy and safety of Selective Serotonin Reuptake Inhibitors and other treatments for depression, and also over the expansion of their use for the treatment of a variety of other conditions. These controversies (...) culminated, in June 2004, with alawsuit intended by Eliot Spitzer, Attorney General of the State of New York. The lawsuit accused pharmaceutical giant GlaxoSmith-Kline of “repeated and persistent fraud by misrepresentation, concealing and otherwise failing to disclose to physicians information in its control concerning the safety and effectiveness of its antidepressant medication paroxetine” in treating children and adolescents suffering from depression. (shrink)
Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the (...) safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade. (shrink)
Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the (...) safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade. (shrink)
An increasing number of community physicians are involved in clinical research.Indeed, 60 of industry-funded research is now spent on community based trials. This surge in community based clinical trials has increased the number of clinical trials applications submitted to the drug regulatory agencies by pharmaceutical sponsors. Many have argued that the commercial interests connected to the conduct and outcome of these trials also increases the potential for conflicts of interest for participating physicians. The context in which these trials take place (...) increases the potential for a host of practices that infringe on ethical, legal and clinical obligations of physicians For example, financial recruitment incentives may lead to violations of the inclusion criteria and the consent process. It may result in inappropriate recruitment of patient participants and a blurring of the ethically significant distinctions between treatment and research. In some cases, it may be hard to distinguish research from the marketing of new products and attempts to influencing prescribing patterns. (shrink)
An increasing number of community physicians are involved in clinical research.Indeed, 60 of industry-funded research is now spent on community based trials. This surge in community based clinical trials has increased the number of clinical trials applications submitted to the drug regulatory agencies by pharmaceutical sponsors. Many have argued that the commercial interests connected to the conduct and outcome of these trials also increases the potential for conflicts of interest for participating physicians. The context in which these trials take place (...) increases the potential for a host of practices that infringe on ethical, legal and clinical obligations of physicians For example, financial recruitment incentives may lead to violations of the inclusion criteria and the consent process. It may result in inappropriate recruitment of patient participants and a blurring of the ethically significant distinctions between treatment and research. In some cases, it may be hard to distinguish research from the marketing of new products and attempts to influencing prescribing patterns. (shrink)
In the last couple of years, serious controversies have raised doubts over the reliability of research supporting the efficacy and safety of Selective Serotonin Reuptake Inhibitors, popular drugs used for the treatment of depression and a variety of related conditions. These controversies have also evoked concerns over the promotional tactics used by industry to promote these drugs. In another article in this volume, David Healy argues that the tactics highlighted by these and some other recent controversies in psychiatry have brought (...) medical research itself to the level of commercial publicity. In the following article, I provide some additional first-hand information about controversies in which David Healy was involved. I then situate these controversies within the context of the increasing commercialization of medical research. I discuss how the controversies highlight the failure of existing regulatory regimes in curbing inappropriate industry influence over research. I critically analyse some of the measures recently promoted by the medical research community, such as the introduction of a clinical trial registry, and I indicate why these measures are insufficient. In conclusion, I highlight how a more radical reform of the clinical trials scene is needed. (shrink)
In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31 207–42 836 young adults aged 18–29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm: per COVID-19 hospitalisation prevented, we anticipate at least (...) 18.5 serious adverse events from mRNA vaccines, including 1.5–4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation). We also anticipate 1430–4626 cases of grade ≥3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation). University booster mandates are unethical because they: (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group; (2) may result in a net harm to healthy young adults; (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission; (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and (5) may result in wider social harms. We consider counterarguments including efforts to increase safety on campus but find these are fraught with limitations and little scientific support. Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates. (shrink)
