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In 2015, the Canadian Supreme Court declared that an absolute Criminal Code prohibition on assisted suicide and euthanasia was unconstitutional. In response, the Canadian parliament enacted Bill C-14 in 2016 permitting assisted suicide and euthanasia for the end-of-life context, which it termed “Medical Assistance in Dying” (MAiD). In 2021, Bill C-7 expanded eligibility for MAiD to those with disabilities not approaching their natural death. By 2021, MAiD accounted for 3.3% of all deaths in Canada with some areas of Canada presently reporting MAiD death rates upward of 7%. In 2021, Canada had 10,064 deaths by MAiD, surpassing all jurisdictions for yearly reported assisted deaths.
To examine the impact of the Canadian MAiD program and analyze its safeguards.
A working group of physicians from diverse practice backgrounds and a legal expert, several with bioethics expertise, reviewed Canadian MAiD data and case reports. Grey literature was also considered, including fact-checked and reliable Canadian mainstream newspapers and parliamentary committee hearings considering the expansion of MAiD.
Several scientific studies and reviews, provincial and correctional system authorities have identified issues with MAiD practice. As well, there is a growing accumulation of narrative accounts detailing people getting MAiD due to suffering associated with a lack of access to medical, disability, and social support.
Significance of results
The Canadian MAiD regime is lacking the safeguards, data collection, and oversight necessary to protect Canadians against premature death. The authors have identified these policy gaps and used MAiD cases to illustrate these findings.
Although few companies are currently applying genetic tests or using genetic data, further developments in genetics will likely increase the role of genetics in the workplace. This article discusses the complex ethical issues raised by the variety of genetic tests that could become available and proposes guidelines for dealing with genetics in the workplace. It discusses how the results of genetic testing could be used for employment purposes, and argues that the existence of unequal bargaining power in the workplace limits the validity of consent as a basis for policymaking. Instead, two specific justifications for genetic testing in the workplace are proposed: the protection of health and the avoidance of harm to others. The author suggests that genetic testing should be permitted only in exceptional circumstances and that every genetic test should be evaluated on its scientific validity and submitted to rigorous review. Existing antidiscrimination law proves to be a useful model for examining the rationality and proportionality of genetic testing in the workplace.
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.
Access to medicine remains a core challenge of global health, despite progress in bringing affordable HIV/AIDS drugs to developing countries. Yet, the debate seems to have shifted. For a long time it focused on two specific issues: (1) whether and to what extent international trade agreements that strengthen patent protection hindered states and NGOs in their efforts to promote access to life-saving medicines at reasonable costs; and (2) whether access to life-saving therapies could be seen as a component of the right to health. The challenge for access to medicines appears at this point, however, to be more political than legal. Indeed, from a legal perspective, it seems fairly settled that international trade agreements permit, under certain conditions, the production and sale or export of generic versions of pharmaceutical products that address an important public health threat in developing countries. The concept of the right to health has often been invoked in this international context. An increasing number of domestic court decisions also explicitly acknowledge that access to life-saving therapies can be seen as a component of the right to health.
Dr. H is an expert on the treatment of depression. A pharmaceutical company, Calaxy Inc. signed a contract with Dr. H and his institution for a multisite three-year study on the efficacy and safety of a new antidepressant, Xanadu, for use in pregnant women. The contract stipulates that Dr. H will have access to all data for final analysis and that all publications based on the study will be submitted for final approval to the sponsor before public disclosure. Dr. H's budget includes money for finder's fees for clinicians who recruit patients into the trial and rewards for clinician–researchers whose patients remain in the trial for the duration of their pregnancy. In the course of the trial, Dr. H becomes worried about potential negative effects of Xanadu on newborns. He reveals his concern to the company, requests immediate access to all the data, and indicates that he will reveal his concerns at an upcoming international meeting. The company refers to a contradictory opinion of an internal data-monitoring committee set up by the sponsor, refuses to provide full access to the data, and points out that researchers have to obtain final approval of the sponsor before any public discussion of the results. Shortly after, Dr. H receives from Calaxy an abstract discussing the interim results of the study, accepted for presentation at an international conference. Dr. H is first author on the abstract, which does not contain any reference to his concerns. Dr. H contacts the chair of his department, Dr. I, who is a remunerated board member of Calaxy.[…]
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.
For more than two decades, significant controversies have been brewing over the efficacy and safety of Selective Serotonin Reuptake Inhibitors (or SSRIs) 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” (better known as “Paxil”) in treating children and adolescents suffering from depression.
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.
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.
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