The First Interchangeable Biosimilar Insulin: Insulin Glargine-yfgn

On March 23, 2020, all insulin products were reclassified as biologics instead of drugs under the Biological Price Competition and Innovation (BPCI) Act of 2009. This allows biosimilar insulin products to be manufactured when the patent expires for the reference biologic, sometimes called the originator or brand name product. A biosimilar product may not be substituted for the reference biologic at the pharmacy counter unless the biosimilar undergoes further switch trials to earn the designation as an interchangeable biosimilar. Insulin glargine-yfgn 100 units/mL is the first biosimilar insulin to attain interchangeable status with the reference insulin glargine. In the INSTRIDE 1 and INSTRIDE 2 trials, insulin glargine-yfgn has proven noninferiority regarding blood glucose reduction and adverse effect profile versus reference insulin glargine; even in the INSTRIDE 3 trial in which treatment of diabetes was switched between insulin glargine-yfgn and reference insulin glargine throughout the trial without statistically significant changes to glucose levels or adverse effects. Insulin glargine-yfgn may be substituted at the pharmacy counter without consultation with the prescriber, in accordance with state laws. In suit with other biosimilars, insulin glargine-yfgn’s list price is significantly lower than other insulin glargine products. This increases market competition leading to decreases in costs of other insulin glargine products. Many patients who could not previously afford insulin therapy may now have significantly improved access to treatment. Providers will need education to increase awareness of these new biosimilars and interchangeable biosimilar insulin products, cost benefits, and substitution allowances.

Two sides of a coin: women’s experiences and providers’ perceptions of assisted conception in urban India

Background: The uptake of assisted reproductive treatments has increased radically in urban India. We aimed to understand women’s lived experiences of assisted conception, and ART providers’ perception of their patients’ experiences.Methods: This study was cross-sectional and we used a qualitative approach and key informant interviews to understand the experiences of women and the treatment providers. Participants were ten women who had conceived through assisted reproductive treatment and ten ART providers. The data was analyzed using Braun and Clarke’s thematic analysis method.Results: During the treatment process, women felt consumed by their need to conceive. They reported that it was difficult for them to focus on other equally important aspects of their life. Stress, depression and anxiety associated with the uncertainty of their treatment outcome were prevalent. Women were also worried about miscarriage, safety and health of their baby, and forming an attachment with their fetus during the pregnancy. Providers’ concurred that women experience significant mood fluctuations in the form of stress, anxiety and depression which impacts treatment adherence and outcome. Women who have adequate spousal and family support are able to navigate the ART process better than women who lack social support.Conclusions: Findings imply the need for screening and brief psychological interventions at different stages of fertility treatment and during the antenatal and postnatal period to enhance women’s emotional well-being.

Governing addiction: The Alcohol and Other Drug Treatment Court in New Zealand

<p>The New Zealand Alcohol and other Drug Treatment Court (AODTC) is an innovative approach to addressing offending by people with an alcohol or other drug addiction. Based on the United States Drug Treatment Court model, the AODTC aims to reduce reoffending, reduce addiction and support offenders’ health and wellbeing. Most studies of DTCs are quantitative and focus on recidivism rates and cost-effectiveness. There have been relatively few in-depth studies of how DTCs operate and even fewer that focus on the offender’s experience. This thesis is a critical study of the Auckland and Waitakere AODTCs and is the first study of its kind in New Zealand. Conducted over seven months, the fieldwork involved 536 hours of observations, interviews with offenders and informal conversations with court workers, treatment providers and offenders’ families. The research also included extensive analysis of documents produced by and about the AODTC pilot and the US counterparts. The research found that the AODTC operates in a largely unregulated problem-solving court zone. The wide discretion of judges and collaboration with community treatment providers, lauded by proponents of the AODTC as key to its therapeutic effectiveness, were found to create a number of significant harms for participants. In addition, the focus on addiction as a disease and abstinence as a goal and measure of progress invites judicial subjectivity and places considerable burdens on participants. The research also found that the AODTC metes out punishment under the guise of treatment, preventing participants from accessing treatment and breach the principle of proportionality in their responses to offending and non-compliance. The competing goals of treatment and punishment also prevent participants from receiving adequate support in the AODTC programme. In particular, Māori, women, transgender, offenders with a coexisting disorder and brain injury are less likely to have access to the right treatment and proper support. These findings challenge the assumptions that the AODTC therapeutic mandate treats AOD related offending and supports offenders’ health and wellbeing. In order to protect AODTC offenders, a series of recommendations for change are made to constrain judicial involvement in treatment, to provide better options for community-based treatment and to ensure appropriate addiction treatment services. Overall, the thesis provides valuable empirical insight into how the AODTC and the criminal justice system constitute AOD offending, addiction treatment policies, and manage the addicted offender to accomplish recovery. It also adds important data to the international pool of DTC ethnographies and problem-solving court literature, providing a point of focus from which to consider broader policy and evaluative criteria of people’s experiences of treatment in the problem-solving court. It is hoped that this research is able to contribute to law reform involving specialist problem solving courts in New Zealand.</p>

Governing addiction: The Alcohol and Other Drug Treatment Court in New Zealand

<p>The New Zealand Alcohol and other Drug Treatment Court (AODTC) is an innovative approach to addressing offending by people with an alcohol or other drug addiction. Based on the United States Drug Treatment Court model, the AODTC aims to reduce reoffending, reduce addiction and support offenders’ health and wellbeing. Most studies of DTCs are quantitative and focus on recidivism rates and cost-effectiveness. There have been relatively few in-depth studies of how DTCs operate and even fewer that focus on the offender’s experience. This thesis is a critical study of the Auckland and Waitakere AODTCs and is the first study of its kind in New Zealand. Conducted over seven months, the fieldwork involved 536 hours of observations, interviews with offenders and informal conversations with court workers, treatment providers and offenders’ families. The research also included extensive analysis of documents produced by and about the AODTC pilot and the US counterparts. The research found that the AODTC operates in a largely unregulated problem-solving court zone. The wide discretion of judges and collaboration with community treatment providers, lauded by proponents of the AODTC as key to its therapeutic effectiveness, were found to create a number of significant harms for participants. In addition, the focus on addiction as a disease and abstinence as a goal and measure of progress invites judicial subjectivity and places considerable burdens on participants. The research also found that the AODTC metes out punishment under the guise of treatment, preventing participants from accessing treatment and breach the principle of proportionality in their responses to offending and non-compliance. The competing goals of treatment and punishment also prevent participants from receiving adequate support in the AODTC programme. In particular, Māori, women, transgender, offenders with a coexisting disorder and brain injury are less likely to have access to the right treatment and proper support. These findings challenge the assumptions that the AODTC therapeutic mandate treats AOD related offending and supports offenders’ health and wellbeing. In order to protect AODTC offenders, a series of recommendations for change are made to constrain judicial involvement in treatment, to provide better options for community-based treatment and to ensure appropriate addiction treatment services. Overall, the thesis provides valuable empirical insight into how the AODTC and the criminal justice system constitute AOD offending, addiction treatment policies, and manage the addicted offender to accomplish recovery. It also adds important data to the international pool of DTC ethnographies and problem-solving court literature, providing a point of focus from which to consider broader policy and evaluative criteria of people’s experiences of treatment in the problem-solving court. It is hoped that this research is able to contribute to law reform involving specialist problem solving courts in New Zealand.</p>

“It’s like ‘liquid handcuffs”: The effects of take-home dosing policies on Methadone Maintenance Treatment (MMT) patients’ lives

Background Methadone Maintenance Treatment (MMT) is widely recognized as one of the most effective ways of reducing risk of overdose, arrest, and transmission of blood-borne viruses like HIV and HCV among people that use opioids. Yet, MMT’s use of restrictive take-home dose policies that force most patients to attend their clinic on a daily, or near-daily, basis may be unpopular with many patients and lead to low rates of treatment uptake and retention. In response, this article examines how clinics’ take-home dosing policies have affected patients’ experiences of treatment and lives in general. Methods This article is based on semi-structured, qualitative interviews with a variety of stakeholders in MMT. Interviews explored: reasons for engaging with, or not engaging with MMT; how MMT is conceptualized by patients and treatment providers (e.g., as harm reduction or route to abstinence and/or recovery); experiences with MMT; perception of barriers to MMT (e.g., organizational/regulatory, social) and how MMT might be improved to support peoples’ substance use treatment needs and goals. Results Nearly all of the patients with past or present MMT use were highly critical of the limited access to take-home doses and consequent need for daily or near daily clinic attendance. Participants described how the use of restrictive take-home dose policies negatively impacted their ability to meet day-to-day responsibilities and also cited the need for daily attendance as a reason for quitting or avoiding OAT. Responses also demonstrate how such policies contribute to an environment of cruelty and stigma within many clinics that exposes this already-stigmatized population to additional trauma. Conclusions Take-home dose policies in MMT are not working for a substantial number of patients and are reasonably seen by participants as degrading and dehumanizing. Revision of MMT regulations and policies regarding take home doses are essential to improve patient satisfaction and the quality and effectiveness of MMT as a key evidence-based treatment and harm reduction strategy.

Drama education as part of a good lives model treatment approach

Purpose Forensic psychiatric treatment is aimed at reducing violence risk factors (Bonta and Andrews, 2017) and achieving positive, prosocial life goals (Willis et al., 2013). Drama education can be provided as part of this treatment, but the evidence base is scarce. Therefore, the present study aims to provide insight into experiences with drama education as part of forensic psychiatric treatment. Design/methodology/approach A qualitative study was conducted, based on participant observation and 16 interviews, to explore the experiences of patients and treatment providers with drama education during forensic psychiatric treatment. Analyses were conducted following the consensual qualitative research method (Hill et al., 1997). Findings The five central themes that emerged from the analysis were knowledge, happiness, excellence in play, community and staff-patient hierarchy. Participants reported that they enjoyed the drama lessons, appreciated the group atmosphere and were able to practice their social-emotional skills. Furthermore, patients and their treatment providers became better acquainted with each other because the power differences between patients and staff decreased during the drama lessons. Practical implications Drama education can be considered a useful part of clinical forensic psychiatric treatment, given the positive experience of participants and its perceived positive impact on treatment. Originality/value This was one of the first studies to examine the influence that drama education may have on forensic psychiatric treatment. Four of the five themes were in line with the good lives model (Willis et al., 2013), indicating that drama education fulfiled basic human needs or “primary goods” that are important to address in forensic psychiatric treatment, as it decreases the need to compensate these goods with criminal behaviour.

Forever young: Gay men and cosmetic medical treatments

Purpose This study aims to explore innate and sociocultural forces that lead gay men to purchase invasive and non-invasive cosmetic medical treatments. Design/methodology/approach This work draws on a literature review and personal reflections to identify and interpret patterns and themes on drivers that encourage gay men to use cosmetic medical treatments. Findings In line with evolutionary theory, the authors suggest that the male proclivity to evaluate a partner’s sexual desirability on the basis of physical appearance and youth remains consistent among gay men. They also posit that sociocultural norms, such as media imagery, portray gay men as physically attractive and youthful. Among gay men, homonormative ideals that define attractiveness fall on a continuum ranging from hyper-masculinity to hypo-masculinity, with each end encouraging gay men to accept different beauty standards. Research limitations/implications To date, service researchers have mostly overlooked the role of evolution in consumers’ propensity to purchase professional services. This study sets the foundation for researchers to consider both instinctual and sociocultural norms that encourage consumers to purchase not only cosmetic medical treatments but also professional services in general. Practical implications Gay men represent a prime target market for cosmetic medical treatment providers, as their desire for physical attractiveness and youth remains constant as they age. Originality/value This study offers novel insights into gay male consumption of cosmetic medical treatments and services from theoretical and practical perspectives.