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In RISE, TV46000 once monthly (q1m) or once every 2 months (q2m) significantly extended time to impending schizophrenia relapse. The current study (SHINE, NCT03893825) evaluated the long-term safety, tolerability, and effect of TV46000.
Methods
Patients completing RISE without relapse (rollover) or newly recruited (de novo) were eligible. The de novo and placebo rollover cohorts were randomized 1:1 to q1m or q2m for ≤56 weeks; the TV46000 rollover cohort continued assigned regimen. Exploratory efficacy endpoints included time to impending relapse and patient centered outcomes (PCOs) including Schizophrenia Quality of Life Scale (SQLS).
Results
334 patients were randomized and received TV46000 q1m (n=172) or q2m (n=162), for 202.3 patient-years [PY] of TV-46000 treatment. Treatment-emergent adverse events (AEs) reported for ≥5% of patients were: overall–injection site pain (event rate/100 PY, n [%]; 23.23, 16 [5%]); de novo (n=109)–injection site pain (56.10, 11 [10%]), injection site nodule (16.03, 6 [6%]), blood creatine phosphokinase increased (16.03, 8 [7%]), urinary tract infection (10.69, 7 [6%]); placebo rollover (n=53)–tremor (18.50, 5 [9%]); TV46000 rollover (n=172)–headache (7.97, n=8 [5%]). Serious AEs reported for ≥2 patients were worsening schizophrenia and hyperglycemia. Kaplan– Meier estimates for remaining relapse-free at week 56 were 0.98 (2% risk; q1m) and 0.88 (12%; q2m). SQLS improved for q1m (least-squares mean change [SE], − 2.16 [0.98]) and q2m (− 0.43 [0.98]); other PCOs (5Level EuroQoL 5Dimensions Questionnaire, Personal and Social Performance Scale, Drug Attitudes Inventory 10-item version) remained stable.
Conclusions
TV-46000 had a favorable long-term benefit–risk profile in patients with schizophrenia.
This book describes the politically charged afterlife of Israeli electronics gathered by and processed in a cluster of rural Palestinian villages that has emerged as an informal regional e-waste hub. As with many such hubs throughout the global South, rudimentary recycling practices represent a remarkable entrepreneurial means of livelihood amidst poverty and constraint, that generates staggering damage to local health and the environment, with tensions between these reaching a breaking point. John-Michael Davis and Yaakov Garb draw on a decade of community-based action research with and within these villages to contextualise the emergence, realities and future options of the Palestinian hub within both the geo-political realities of Israel's occupation of the West Bank as well as shifting understandings of e-waste and recycling dynamics and policies globally. Their stories and analysis are a poignant window into this troubled region and a key sustainability challenge in polarized globalized world.
We describe the minute details of cable copper extraction through burning, and the persistence of the phenomenon despite local harms and frustrations, and our development of a sustainable and economically viable alternative to burning, in the form of a mechanical cable grinding facility. We describe the successful piloting of this facility, through initial subsidy for free grinding in tandem with a community policing mechanism, in which community volunteers would report burns as they occurred, and a response team would rapidly approach the burners to interview them and offer them vouchers for free grinding of their materials. Alongside the indicators of the success of this pilot intervention, we also report on the political barriers we encountered in institutionalising and expanding it for the longer term.
This chapter opens with a community meeting in the West Line about the e-waste issue as an example of how multiple social locations and perspectives of different community actors can be selectively narrowed in public forums and community interfaces with outside actors. In this case, the meeting foregrounded e-waste’s pollution harms and dumping narratives while eclipsing its economic/livelihood dimension. This episode leads us to a review of the complexity, challenges, and importance of representative community engagement in development projects, and how shortcuts to “participatory” development can overlook social heterogeneity, bolstering the visibility and power of certain segments within a diverse and at times contentious community. We describe the social and political divisions within the West Line villages, and our effort to generate a broadly endorsed development proposal with this community through a novel Delphi-like method. We describe the iterative procedure we adopted and how it enabled convergence on a development trajectory that proved broadly consensual, namely a social and environmental upgrading of the e-waste industry that would preserve livelihoods while reducing its harms. We reflect on the irony of the apparent success of this outside intervention in broadening and facilitating a community participation process.
We review the emergence of the West Line hub that has processed most of Israel’s e-waste for over two decades against the background of the global phenomena of e-waste policies and hubs often characterised as simply dumping grounds at the receiving end of flows of contaminating processes and materials to less regulated settings (the Pollution Haven Hypothesis, PHH). Its emergence was facilitated by factors common to the occupied West Bank as a whole (de-development, lower labor costs, dominance of the informal sector, a porous border and spatial fragmentation), and others especially important in the West Line area. These include the disruption of work opportunities in Israel alongside a rise in the amounts and value of e-waste; proximity to Israeli urban centers and distance from Palestinian ones; the historical presence of a scrap trade; a population comprised of a handful of extended families facilitating trust-based economies, on the one hand, while overcoming stigma and opposition on the other; and availability of areas of governance vacuum allowing dumping and burning. The PHH’s crudely global account of e-waste hub emergence must be refined to include the context-specific presence and operation of hubs as forceful economic agents, not simply passive recipients of waste dumping.
Our focus in this chapter is the burn sites themselves. We describe the toxic substances released, the massive environmental and health problems these present, the importance of including remediation of these sites as an integral part of e-waste policies, and our piloting of such remediation. While such toxic sites figure centrally in the scientific literature on e-waste and iconic portrayals of e-waste hubs, figuring implicitly or explicitly as a key motivator for EPR policies that would redirect waste away from e-waste hubs, they figure very little in e-waste policies themselves. Thus, such policies risk giving e-waste hubs the worst of two worlds: relocating the sources of their livelihood away to central capital-heavy recycling facilities without removing the contamination that would continue to harm their landscapes and health for decades to come. We describe the details of our pilot cleanup of one such site, our development of a framework for scaling this up to remediate the most serious sites in the West Line, and how this scaleup fell afoul of disputes of principle regarding national sovereignty and more mundane tensions between central and local authorities within the Palestinian Authority.
This chapter describes the global and local ramifications of the emergence, dominance, and policy derivatives of an e-waste dumping paradigm focused on the transfer of contaminants from the Global North to helpless “digital dumpsites”: peripheral locations suffering grievous environmental and health impacts. Though derived with only a thin linkage to realities in these locations, these caricatured portrayals resonate strongly in the Global North, and undergird key platforms of e-waste regulation, the Ban Amendment to the Basel Convention and Extended Producer Responsibility (EPR) policies now a hegemonic model for e-waste collection and recycling. Ironically, this paradigm bypasses the informal sector, its vital livelihood contributions to these places and central role within the scrap value chain, and redirects resources, attention, and agency away from dynamics and actors key to systemic reform and local sustainability. Thus, EPR’s forwarding-looking and formalizing agenda can leave the places it aspires to save with the worst of both worlds: deprived of livelihoods and saddled with the legacy of past contamination. We describe this global paradigm’s local resonances in the ironically convergent thrusts of emerging Israeli EPR legislation, local and national NGO voices in Israel and Palestine, and the sovereignty aspirations of a distant Palestinian Authority.
We build on Chapter three’s description of e-waste hubs as vital economic actors, rather than simply dumping sites, and Chapter four’s account of a consensual development vision for the West Line hub, to argue for the pragmatic and ethical necessity and advantages of centering e-waste hubs in e-waste policies. Existing EPR e-waste policies, generated in the Global North and adopted globally, usually ignore informal actors and dynamics, or propose formalizing them in a way that redirects attention and resources away from the value chains and sites that have historically collected and recycled most of the world’s e-waste. A hub-centered policy would boost the effectiveness and coherence of e-waste policies by accounting for and building on their entrepreneurial agility and expertise, decentralising decisions and interventions to actors with nuanced local knowledge, greater accountability, and long-term stakes in policies that not only propose solutions in the center but grapple with existing capacities and toxic legacies in the periphery. We briefly describe the interlocked arms of the West Line model for such restructuring elaborated in the following three chapters: curbing destructive practices through local enforcement; remediating past damage; and preserving livelihoods though environmental upgrading of the recycling processes.
This chapter details the West Line e-waste economy as an example of global destruction networks operating globally as an under-examined shadow of the more familiar and visible phases of the economy. It traces the highly effective collection pathways developed by Palestinian entrepreneurs to locate and funnel end-of-life materials from Israeli households, institutions, and scrapyards to the West Line, along with lesser inputs from Palestinian areas. We describe the navigation of borders, including through mediation of Israeli settlers, as a cascading flow of scrap arrives to the West Line, for resale, repair, and processing, with valuable metals extracted for export back to Israel, and low value remnants disposed. This informal economic value chain employs a complex hierarchy of a thousand workers, operating in an ecosystem of interlocked dynamic niches of specialization and synergy, ranging from multi-million dollar metal traders to children picking through ash for pieces of copper, producing one of the largest Palestinian exports to Israel. At the same time, similar to other hubs globally, these vibrant economic contributions in a context of scarce opportunity are in increasingly tense relations with the wide-ranging severe environmental and health impacts of the crude extraction and disposal practices employed and international scrutiny.
This chapter describes the cross border geopolitical terrain within which we advocated Israeli and Palestinian authorities on behalf of the hub-driven path to reform described in previous chapters. The impressive entrepreneurial accomplishments of the West-Line’s informal recycling industry, and our arguments for its social and environmental upgrading came up against the harsh constraints of regional politics and policies. On the Israeli side, an increasingly tense and militarized response to waste smuggling and burning meshed with a narrow vision of Israeli e-waste management policies modeled on the internationally dominant EPR system. This impulse converged, ironically, with the stance of the Palestinian Authority. Here, officials regarded waste flows as a joint manifestation of Israeli dumping and the criminality of marginal individual Palestinians. The Authority’s battle for symbolic expressions of sovereignty in a context where it possesses almost none of its substance, formally allows the recycling of only that small fraction of e-waste that is indigenously Palestinian—a convenient fiction that blocks formal commercial recycling. For example, the foremost example of a Palestinian company performing large scale clean recycling on a commercial basis is not showcased as a way forward, but faces constant friction from both Israeli and Palestinian institutional and regulatory barriers.
The preface describes how a chance story about black rain interfering with the traditional drinking water collection from village rooftops, led us to a massive but little-known Palestinian e-waste hub in the southern West Bank, employing a thousand people who work to collect, refurbish, and recycle a large portion of Israeli e-waste, creating livelihoods in a setting of few options after prolonged Israeli occupation of the West Bank. We describe our efforts to learn with and from these communities about the dynamics and scale of the informal e-waste value chain, and its serious environmental and health consequences, and to forge and test a vision for development that would preserve this precious source of livelihood while eliminating its crippling harms. We overview the intertwined stories we tell in the book about our years of community-based research and advocacy, and their lessons for different audiences.
This chapter captures the current state-of-play of the West Line hub in a continually turbulent region, speculating on how things might and should go in the future – both in the West Line and in other e-waste hubs that share many dynamics and predicaments. The future of the West Line and its long-standing e-waste industry teeter in the balance, buffeted by geopolitical currents. The West Line waste flows and burning emerged from the Israeli-Palestinian conflict and have embodied it for decades, in a way that is increasingly salient in the recent years of a right-wing coalition government, and intensified conflict after October 7, 2023. The politics of waste is now explicit, with Palestinian municipal rubbish collection trucks blocked by military checkpoints, and Israelis calling for a creeping “green” annexation of Area C and whittling away of Palestinian authority in Areas A and B as the only way to prevent the “chemical terrorism” of waste burning. While these regional politics, which have so frustratingly frozen our promising hub-driven efforts, are surely sui generis, the underlying challenges are instructive globally for the interfaces between the e-waste hubs, environmental NGOs, and national e-waste policies, and this chapter closes in teasing out these broader lessons.