Mitochondrial replacement techniques: who are the potential users and will they benefit?

The file attached to this record is the author's final peer reviewed version.In February 2015 the UK became the first country to legalise high-profile mitochondrial replacement techniques (MRTs), which involve the creation of offspring using genetic material from three individuals. The aim of these new cell reconstruction techniques is to prevent the transmission of maternally inherited mitochondrial disorders to biological offspring. During the UK debates, MRTs were often positioned as a straightforward and unique solution for the ‘eradication’ of mitochondrial disorders, enabling hundreds of women to have a healthy, biologically-related child. However, many questions regarding future applications and potential users remain. Drawing on a current qualitative study on reproductive choices in the context of mitochondrial disorders, this paper illustrates how the potential limitations of MRTs have been obscured in public debates by contrasting the claims made about the future beneficiaries with insights from families affected by mitochondrial disorders and medical experts. The analysis illuminates the complex choices with which families and individuals affected by mitochondrial disorders are faced, which have thus far remained invisible. An argument is presented for improved information for the public as well as an intensification of critical empirical research around the complex and specific needs of future beneficiaries of new reproductive biotechnologies

Co-parenting arrangements in lesbian and gay families: when the ‘mum and dad’ ideal generates innovative family forms

Health Policy Research Unit This is a post-peer-review, pre-copy edited version of an article published in Families, Relationships & Societies. The definitive publisher-authenticated version is available online at DOI below.This paper engages with current debates on the potential of contemporary family formations, particularly those created by lesbian women and gay men, to challenge hegemonic family models. Drawing on in-depth interviews with lesbian and gay individuals living in Belgium, it explores parental ideals and family practices amongst people actively choosing ‘co-parenting arrangements’ which include more than two adults raising a child. It examines how this route to parenthood was justified by co-parents’ desire for a biological child, to experience pregnancy, to know the child’s background and most importantly, to provide the child with a mother and a father. These motivations not only aimed at normalising their family situation but reflected deeply anchored family values. The paper demonstrates how innovative and reflexive family forms can arise from conventionally-based assumptions regarding gender roles and kinship, and calls therefore for a more nuanced consideration of individual values and intentions in parenting which potentially destabilise the hegemonic family model

Mitochondrial donation, patient engagement and narratives of hope

Health Policy Research UnitThis article develops the sociology of hope and patient engagement by exploring how patients’ perceptions and actions are shaped by narratives of hope surrounding the clinical introduction of novel reproductive techniques. In 2015, after extensive public debates, the UK became the first country to legalise mitochondrial donation techniques aimed at preventing the transmission of inherited disorders. The article draws on the accounts of twenty-two women of reproductive age who are at risk of having a child with mitochondrial disease and would be the potential target of the techniques. We explore the extent to which our participants engaged with the public debates and how they accounted for their support of mitochondrial donation. We show that while the majority of our participants were in favour of legalisation, they did not necessarily wish to use the techniques themselves. We found that hope was multi-faceted, involving hope for self, hope for family and hope for society. We conclude by considering the implications of hope narratives for patients and families and the important but potentially limited role that patients can play as advocates for technology

Ideals, negotiations and gender roles in gay and lesbian co-parenting arrangements

Health Policy Research Unit The file attached to this record is the author's final peer reviewed version. The Publisher's final version can be found by following the DOI link.This paper engages with the complex gender and parental dynamics experienced in the context of co-parenting arrangements. These arrangements, based on mutual agreement, involve people who commit to raising a child together, possibly with their respective partners. These family forms are usually pursued to avoid what is perceived as the uncertainty surrounding alternative assisted reproductive options such as donor insemination or surrogacy, and to allow the child to have two biological and sexually differentiated parental figures. This paper explores some of the opportunities and challenges presented by co-parenting by focusing on the experiences and accounts of lesbian women and gay men engaged in such family arrangements. Drawing on work by social theorists of the family, the main characteristics of these arrangements are first examined to show that while co-parenting might first seem marginal, it appears particularly well adapted to contemporary social constraints and parenting expectations. The second part of the paper shows how in practice, dominant gender norms remain largely unquestioned and can lead to tensions and unbalanced parental power relationships between biological parents, which in turn, can present a significant challenge to these family arrangements. The analysis therefore suggests that while co-parenting offers the potential for parents to reconcile contradictory social expectations and provide them with opportunities to create family practices that suit them, these are restrained by existing gender norms, in particular by the prevailing role of the biological mother

Gender, kinship and assisted reproductive technologies: future directions after 30 years of research

Health Policy Research UnitThis volume of Enfances Familles Générations (Childhood Families Generations) looks at the current issues raised by the advent and proliferation of assisted reproductive tech-nologies with a particular focus on kinship and gender. In the contemporary globalised world, a range of reproductive possibilities are now available, many of which raise im-portant socio-anthropological questions related to the balance of power inherent in such interactions, the different practices and regulations involved in the delivery of ART and the individual and cultural significance of these practices. These issues have generated a rich and extensive body of literature over the past thirty years, particularly in English language scholarship. This introductory paper provides a reminder of these debates and seeks to foster dialogue with respect to work across different disciplines, by underscoring their respective contributions, particularly those in English- and French-language litera-ture. Beginning with the summarizing of the major issues and contributions stemming from ART studies with respect to gender and parenthood, we shall underline the issues that are yet to be resolved and that, in our opinion, warrant further investigation. The main line of our argument is that, based on available literature and on social science re-search, emphasis must be placed on gender as inextricably linked to the experience and the study of assisted reproductive technologies

Marketing, the past and corporate heritage

Argues for a more expansive conceptualisation of the past’s relevance in, and for, marketing. Such a differentiated approach to the past is pregnant with possibilities in terms of advancing scholarship apropos temporal agency in marketing along with consumption practices. Symptomatic of this perspective is the increased mindfulness of the rich palate of past-related concepts. Significantly, the corporate heritage notion - because of its omni-temporal nature - represents a distinct and meaningful vector on the past by coalescing the past, present and future into a new type of temporality. As such, the authors reason this expansive conceptualisation of ‘the past-in-marketing’ is both timely and efficacious. Whilst sensitive of the importance of the historical method in marketing and the history of marketing scholarship and practice per se. This broader marketing approach to and of the past highlights the ideational and material manifestations of the past-in-the-present and an envisaged past-in-the future

Clinical trial evidence supporting US Food and Drug Administration approval of novel cancer therapies between 2000 and 2016

Importance: Clinical trial evidence used to support drug approval is typically the only information on benefits and harms that patients and clinicians can use for decision-making when novel cancer therapies become available. Various evaluations have raised concern about the uncertainty surrounding these data, and a systematic investigation of the available information on treatment outcomes for cancer drugs approved by the US Food and Drug Administration (FDA) is warranted. Objective: To describe the clinical trial data available on treatment outcomes at the time of FDA approval of all novel cancer drugs approved for the first time between 2000 and 2016. Design, Setting, and Participants: This comparative effectiveness study analyzed randomized clinical trials and single-arm clinical trials of novel drugs approved for the first time to treat any type of cancer. Approval packages were obtained from drugs@FDA, a publicly available database containing information on drug and biologic products approved for human use in the US. Data from January 2000 to December 2016 were included in this study. Main Outcomes and Measures: Regulatory and clinical trial characteristics were described. For randomized clinical trials, summary treatment outcomes for overall survival, progression-free survival, and tumor response across all therapies were calculated, and median absolute survival increases were estimated. Tumor types and regulatory characteristics were assessed separately. Results: Between 2000 and 2016, 92 novel cancer drugs were approved by the FDA for 100 indications based on data from 127 clinical trials. The 127 clinical trials included a median of 191 participants (interquartile range [IQR], 106-448 participants). Overall, 65 clinical trials (51.2%) were randomized, and 95 clinical trials (74.8%) were open label. Of 100 indications, 44 indications underwent accelerated approval, 42 indications were for hematological cancers, and 58 indications were for solid tumors. Novel drugs had mean hazard ratios of 0.77 (95% CI, 0.73-0.81; I2 = 46%) for overall survival and 0.52 (95% CI, 0.47-0.57; I2 = 88%) for progression-free survival. The median tumor response, expressed as relative risk, was 2.37 (95% CI, 2.00-2.80; I2 = 91%). The median absolute survival benefit was 2.40 months (IQR, 1.25-3.89 months). Conclusions and Relevance: In this study, data available at the time of FDA drug approval indicated that novel cancer therapies were associated with substantial tumor responses but with prolonging median overall survival by only 2.40 months. Approval data from 17 years of clinical trials suggested that patients and clinicians typically had limited information available regarding the benefits of novel cancer treatments at market entry