Published data show that new HIV prevention strategies including treatment‐as‐prevention and pre‐exposure prophylaxis (PrEP) using oral antiretroviral drugs (ARVs) are highly, but not completely, effective if regimens are taken as directed. Consequently, their implementation may challenge norms around HIV prevention. Specific concerns include the potential for ARV‐based prevention to reframe responsibility, erode beneficial sexual norms and waste resources. This paper explores what rights claims uninfected people can make for access to ARVs for prevention, and whether moral claims justify the provision (...) of ARV therapy to those who do not yet clinically require treatment as a way of reducing HIV transmission risk. An ethical analysis was conducted of the two strategies, PrEP and treatment‐as‐prevention, using a public health stewardship model developed by the Nuffield Bioethics Council to consider and compare the application of PrEP and treatment‐as‐prevention strategies. We found that treating the person with HIV rather than the uninfected person offers advantages in settings where there are limited opportunities to access care. A treatment‐as‐prevention strategy that places all the emphasis upon the positive person's adherence however carries a disproportionate burden of responsibility. PrEP remains an important option for receptive partners who face increased biological vulnerability. We conclude that the use of ARV for prevention is ethically justified, despite imperfect global to drugs for those in clinical need. The determination of which ARV‐based HIV prevention strategy is ethically preferable is complex and must take into account both public health and interpersonal considerations. (shrink)

Vaccination is a highly effective public health strategy that provides protection to both individuals and communities from a range of infectious diseases. Governments monitor vaccination rates carefully, as widespread use of a vaccine within a population is required to extend protection to the general population through “herd immunity,” which is important for protecting infants who are not yet fully vaccinated and others who are unable to undergo vaccination for medical or other reasons. Australia is unique in employing financial incentives to (...) increase vaccination uptake, mainly in the form of various childcare payments and tax benefits linked to timely, age-appropriate vaccination. Despite relatively high compliance with the childhood vaccination schedule, however, the Australian government has determined that rates should be higher and has recently introduced policy that includes removing certain tax and childcare benefits for non-vaccinators and formally disallowing conscientious objection to vaccination. In addition, it has raised the possibility of banning unvaccinated children from childcare centres. This article examines the impact of coercive approaches to childhood vaccination and raises the question of the ethical justification of health policy initiatives based on coercion. We consider the current evidence regarding childhood vaccination in Australia, the small but real risks associated with vaccination, the ethical requirement for consent for medical procedures, and the potential social harms of targeting non-vaccinators. We conclude that the evidence does not support a move to an increasingly mandatory approach that could only be delivered through paternalistic, coercive clinical practices. (shrink)

In 2010, randomized controlled trials (RCTs) of two different biomedical strategies to prevent HIV infection had positive findings. However, despite ongoing very high levels of HIV infection in some countries and population groups, it has been made clear by regulatory authorities that the evidence remains insufficient to support either product being made available outside of research contexts in the developing world for at least two years. In addition, prevention trials in endemic areas will continue to test new interventions against placebo. (...) But the judgments of evidentiary standards are never value-neutral. Using the recent trials and their contexts as case studies, we examine the basis for these decisions, which will potentially delay access to scientific innovation to the people who are most urgently in need of it. (shrink)

This study investigated patient preferences for various types of physician persuasion strategies. Four types of persuasion strategies were utilized which involved combination of high and low levels of affectivity and information. In addition, patient variables, receiver apprehension and health beliefs were introduced to predict preference choices by patients. Results indicated that patients are influenced in their decision-making (preferences) by the type of persuasive strategy employed. Further, patients with different characteristics and predispositions prefer different persuasive strategies. The results of this study (...) suggest that the success of physician persuasiveness is dependent upon the type of strategy used and the type of patient being persuaded. (shrink)

The American Journal of Bioethics, Volume 11, Issue 12, Page 48-50, December 2011.

Published data show that new HIV prevention strategies including treatment-as-prevention and pre-exposure prophylaxis (PrEP) using oral antiretroviral drugs (ARVs) are highly, but not completely, effective if regimens are taken as directed. Consequently, their implementation may challenge norms around HIV prevention. Specific concerns include the potential for ARV-based prevention to reframe responsibility, erode beneficial sexual norms and waste resources. This paper explores what rights claims uninfected people can make for access to ARVs for prevention, and whether moral claims justify the provision (...) of ARV therapy to those who do not yet clinically require treatment as a way of reducing HIV transmission risk. An ethical analysis was conducted of the two strategies, PrEP and treatment-as-prevention, using a public health stewardship model developed by the Nuffield Bioethics Council to consider and compare the application of PrEP and treatment-as-prevention strategies. We found that treating the person with HIV rather than the uninfected person offers advantages in settings where there are limited opportunities to access care. A treatment-as-prevention strategy that places all the emphasis upon the positive person's adherence however carries a disproportionate burden of responsibility. PrEP remains an important option for receptive partners who face increased biological vulnerability. We conclude that the use of ARV for prevention is ethically justified, despite imperfect global to drugs for those in clinical need. The determination of which ARV-based HIV prevention strategy is ethically preferable is complex and must take into account both public health and interpersonal considerations. (shrink)

The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and (...) regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account. (shrink)

The successful demonstration that antiretroviral (ARV) drugs can be used in diverse ways to reduce HIV acquisition or transmission risks – either taken as pre-exposure prophylaxis (PrEP) by those who are uninfected or as early treatment for prevention (T4P) by those living with HIV – expands the armamentarium of existing HIV prevention tools. These findings have implications for the design of future HIV prevention research trials. With the advent of multiple effective HIV prevention tools, discussions about the ethics and the (...) feasibility of future HIV prevention trial designs have intensified. This article outlines arguments concerning the inclusion of newly established ARV-based HIV prevention interventions as standard of prevention in HIV prevention trials from multiple perspectives. Ultimately, there is a clear need to incorporate stakeholders in a robust discussion to determine the appropriate trial design for each study population. (shrink)

In many countries around the world, people who inject drugs remain at high risk of HIV acquisition not because effective forms of prevention are unknown, nor because they find effective prevention undesirable, but because those in charge, mainly politicians but also bureaucrats, find evidence-based practice politically unacceptable. The evidence for preventive efficacy of harm reduction strategies, most prominently needle and syringe programmes but also treatment programmes such as opiate substitution, is irrefutable.1 However, political responses to drug use issues are varied (...) and complex, so the will to implement appropriate harm reduction programmes in the interests of public health remains lacking in too many jurisdictions. As a consequence, the discussion of how best, in the context of research, to reduce HIV incidence in populations of people who inject drugs but are not offered comprehensive access to known prevention strategies is—tragically—an important one. Dawson et al 2 focus on access to sterile injecting equipment and recognise that this should remain the ‘default’ standard of prevention for HIV prevention trials involving people for whom injecting drug use is the primary risk factor for HIV acquisition. ‘Standard of prevention’ means the background or minimal HIV risk reduction interventions offered to all participants in a trial, regardless of what other investigational interventions they are assigned to receive. The standard of prevention concept is grounded in the ethical principle of beneficence—that researchers and sponsors are obliged to maximise benefits and minimise risks to participants in research studies.3 …. (shrink)

In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must produce knowledge that may not have any immediate benefits for the research participant. This tension is exacerbated in HIV research in low and middle income countries, which frequently uncovers comorbidities other than the condition under study. Some bioethicists argue that as the goals of medicine and those of research are distinct, (...) it is a mistake for researchers to assume therapeutic responsibilities while engaging in research. Others propose that there is a duty of care, but disagree as to how this is limited and specified. In this qualitative study, principal investigators from HIV prevention trials discuss their experience of providing medical benefits to participants within the context of conducting research into HIV biomedical prevention technologies. They describe the limitations imposed at times by funders and at times by infrastructure constraints, and canvass the importance of ancillary care provision and capacity building in trial communities. The views of the principal investigators are compatible with the perspective that there is a duty of care, limited by the nature of the research, the depth of the relationship between research and participant, and the capacity of the research site. The therapeutic orientation in HIV prevention trial appears to be indivisible from competent research practise by making concrete and appropriate benefits available to trial participants and their communities that support rather than compete with local infrastructure. (shrink)

Volume 20, Issue 10, October 2020, Page 47-49.

This article examines the relationship between bioethics and the therapeutic standards in HIV prevention research in the developing world, focusing on the closure of the pre-exposure prophylaxis (PrEP) trials in the early 2000s. I situate the PrEP trials in the historical context of the vertical transmission debates of the 1990s, where there was protracted debate over the use of placebos despite the existence of a proven intervention. I then discuss the dramatic improvement in the clinical management of HIV and the (...) treatment access movement, and consider how these contexts have influenced research practice. I argue that as HIV prevention trials oblige researchers to observe the rate at which vulnerable people under their care acquire HIV, there is an obligation to provide antiretroviral treatment to seroconverters and other health care benefits that fall within the scope of researchers' entrustment, both to avoid exploitation and to enact reciprocal justice. I argue against propositions that the obligations to provide specific benefits are vague, fall only upon researchers and sponsors, and create injustices by privileging the few over the many. Finally, I contend that the realisation of a broader standard of care in HIV prevention research broadens the role of research from being a simple tool to produce knowledge to a complex intervention that can play a part in the reduction of health disparities. (shrink)

This paper exposes the relation between the different mathematical orientations, on the one hand, and the modes of documentary film on the other. When we take, with Badiou, mathematics as ontology, and mathematical orientations as orientations to Being, we find in the structural similarity of mathematics and documentary an equivalence: between modes of documentaryand mathematical-ontological decisions, regarding the inscription of 'what is'. From here we move to consider Badiou's notion of 'in-appearing' through a reading of Alain Resnais' documentary Night and (...) Fog. (shrink)

Qu'est-ce que la philosophie? Cette question simple ne devrait pas poser de véritables difficultés puisque nous utilisons régulièrement le mot ainsi que ceux de même famille. Mais une fois que l'on a rappelé son origine grecque et son étymologie, beaucoup se trouvent embarrassés. Puisque la philosophie occidentale est née chez les Hellènes avant d'être transmise aux Romains, c'est en s'intéressant à cette longue période qui va de Thalès de Milet à Plotin que l'on pourra trouver une réponse. Au-delà des différences (...) d'écoles, pourquoi tous ces hommes se disent-ils philosophes? Au-delà de leurs querelles, pourquoi sont-ils d'accord pour affirmer qu'ils font de la philosophie? Qu'est-ce que la philosophie chez les pères de la philosophie? (shrink)

In their recent paper‘Undue inducement: a case study in CAPRISA 008’, Mngadi et al conclude that a participant in an HIV prevention study who deliberately concealed her pregnancy was not ‘unduly induced’ to participate by the offer of an experimental product. This paper argues that while the authors’ conclusion is sound, the framing of this case study is consistent with the preoccupation in research ethics with the concept of undue inducement, coupled with a highly risk-averse attitude to pregnancy. We suggest (...) that the critical research ethics question raised by Mngadi et al ’s case study is not ‘undue inducement’, but the exclusion of pregnant women from research studies where the risks are acceptable to the potential participant, and benefits likely. We also suggest that current regulatory paradigms regarding pregnancy are both overly paternalistic and value the fetus over the mother. In order to ensure timely provision of new HIV prevention agents, we argue that there is a need for expeditious testing of proven effective agents in pregnancy, with due consideration given to situations where preliminary efficacy data exist but fall short of licensure standards. This requires a paradigm shift from researchers, funders, regulators and ethical review bodies towards practices that critically examine the legitimacy of the exclusion of pregnant women on a study-by-study basis. (shrink)

In his article ‘The Ebola Clinical Trials: a precedent for research ethics in disasters’, Philippe Calain constructs a compelling case as to why and how experiences from the recent Ebola epidemic should be used to develop a framework for disaster research ethics. In particular, Calain proposes a useful model for assessing whether or not an unproven intervention could be suitable for human use in a disaster context, and makes a powerful argument against the separation of patient care from research goals. (...) In this commentary, I argue that the separation of patient care goals from research goals is also unhelpful in the context of other forms of participant disadvantage even when that disadvantage is less severe than an ongoing public health emergency. I contend that recognising that research in disadvantaged populations is an intervention that could and should aim to produce positive outcomes for participants, just as it should in disaster contexts, therefore seems a well-justified lesson that can be extrapolated from the experience of the Ebola epidemic. (shrink)

In July 2012, based on evidence from two major trials, the United States Food and Drug Administration approved the use of combined oral tenofovir/emtricitabine as pre-exposure prophylaxis for people at high risk of HIV acquisition. PrEP effectiveness is marred by poor adherence, however, even in trial populations, thus it is not a magic bullet for HIV prevention. It is, however, the most effective biomedical HIV prevention intervention available for people at high risk of HIV, particularly those who have receptive sex (...) and lack the power to negotiate condom use. Accordingly, there are compelling reasons to compare future experimental HIV prevention interventions against PrEP. The interests both of trial participants and of science are served by using PrEP as comparator: Not only would HIV incidence be reduced, but also the question of whether new interventions were superior to best proven interventions, in a given setting, would be answered comprehensively. (shrink)

This chapter contains sections titled: “Christmas is here. Lovely, glorious, beautiful Christmas …” “Some men are Baptists, others Catholics; my father was an Oldsmobile man” “There it is, the ‘Holy Grail’ of Christmas presents …” “We plunged into the cornucopia quivering with desire and the ecstasy of unbridled avarice”.

Robert Preece’s The Psychology of Buddhist Tantra and Khenchen Thrangu Rinpoche’s Everyday Consciousness and Primordial Awareness are reviewed. Both books address Tibetan Buddhism, and their common threads underscore this discussion. Even when separated from their original contexts, the Tibetan Buddhist teachings offer understandings about a common human nature and a method of transforming consciousness through awareness.

Voor de taalgebruiker spreekt taal vanzelf, maar de taalonderzoeker staat voor raadsels. Woordvormen lijken in niets op hun betekenis. En taalconstructies lijken onlogisch in elkaar te zitten. Toch kunnen we in een enkele zin onze bedoelingen tot in de subtielste nuances duidelijk maken. We hebben geen toegang tot het bewustzijn van de Ander maar kunnen desondanks gedachten met elkaar uitwisselen. We kunnen de werkelijkheid met elkaar bespreken en fictieve werelden met elkaar delen alsof ze toch ergens buiten onszelf bestaan. De (...) taalgebruiker heeft er allemaal geen moeite mee. In De magie van taal brengt Net Koene stap voor stap in kaart wat zich in ons hoofd afspeelt wanneer we naar de Ander luisteren. Ze isoleert taalvormen, woorden, constructies, toonhoogte- en ritmekenmerken die we als informatief herkennen in wat de Ander zegt. Ze laat zien hoe al die vormen systematisch hun eigen bijdrage leveren aan onze voorstelling van waar de Ander het over heeft. De auteur toont deze processen vanuit een denkbeeldig alwetend perspectief, in dit boek Omega genoemd. Binnen dit theoretische kader legt ze per hypothese verband tussen wat in het bewustzijn opkomt en de machinerie van het brein: hoe vormt de wereld van onze zintuigen zich, hoe komt ons voorstellingsvermogen tot stand, hoe transformeert de zintuiglijke wereld in een bespreekbare wereld? En vooral: hoe werkt het dat we de inhoud van ons bewustzijn op dat van de Ander kunnen afstemmen? (shrink)

Dental caries is the main oral health challenge for children in Nigeria. Concern about its negative impact makes screening for caries in children an attractive public health strategy. The ability to detect the preclinical phase of caries, the availability of screening tools with high accuracy, and the possibility of treatment before onset of clinical symptoms with significant cost and health benefits, makes it appropriate for screening. However in Nigeria, the poor availability of highly specific and sensitive screening tools, poor access (...) to oral health care and concerns with pre-screening consent, raise the question of the appropriateness of conducting screening programmes for children. We argue that a number of structural challenges associated with poor uptake of oral health care services need to be addressed before screening for caries can be considered ethically appropriate. These include facilitating access of children to quality oral health care and a systematic national approach to oral health impl... (shrink)

Jeff Bernard was a distinguished semiotician, always au courant with the main accomplishments in the field. Although Jeff himself had specialized in socio-semiotics, his architectural training and his artistic youth had lent him a really open mind, able to comprehend almost everything.Jeff Bernard was also an excellent administrator. He and Gloria organized countless international conferences, most of them based in Vienna (at the Institute for Socio-Semiotic Studies Jeff was the director of ), but also in other places in Austria, Germany, (...) Italy. All of them were a success. Jeff ran the ISSS almost single-handed. He edited books (he published three of mine, among many, many others), anthologies, semiotic journals. He knew how to raise funding, of which the whole semiotic community benefitted. In 2003, he acted as my “impresario”, as he jokingly said, and organized a lecturing tour through Central Europe for me.Jeff was also a wonderful host; he considered his guests as part of the family and treated them accordingly. Many were the times when he picked me up from one Viennese railway station or the other, or when he drove me there, when I stopped in Vienna, to or from other places. It was owing to Jeff and Gloria that I discovered Grinzig, Baden, and various other cozy places in and around Vienna. Last but not least, it was also due to Jeff and Gloria that I discovered the charm of many Viennese restaurants.Jeff was kind and generous, elegant and discreet. He helped quite a lot of semioticians to forward their careers, and more important still, he did it unobtrusively. Jeff was also a likeable person, with an entertaining conversation and a fine sense of humor.“I am a Feminist”, Jeff once said. (For the sake of historical accuracy, it was in September 1997, round a dinner table at the Early-Fall School of Semiotics, thenheld in Bankya, Bulgaria). And he further expanded: “Otherwise, we couldn’t be living with Gloria. And my life would be pretty difficult, virtually surrounded as I am by so many professional women. But they all think I am a Feminist, and they are happy to work for my benefit. So I sit at my desk in Vienna, and my women colleagues from all over the world send me contributions for this and that, come over to participate in conferences, etc. It pays being a Feminist”.“Ich bin ein Berliner”, said Jeff on another occasion. For historical accuracy, it was in September 2003, during the conference celebrating his 60th birthday, in answer to a remark made by Roland Posner. It seemed a humorous statement, and everybody smiled. But I think this was true in spirit. These few lines, as well as (I suppose) those written by other colleagues who have contributed to the present issue, are meant to illustrate this self-definition. Jeff had always sympathized with the less privileged people everywhere. (shrink)