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Breast cancer is one of the most commonly diagnosed cancers and a leading cause of death for women worldwide. With advances in molecular engineering in the 1980s, hopes began to rise that a non-toxic and non-invasive treatment for breast cancer could be developed. These hopes were stoked by the researchers, biotech companies, and analysts who worked to make sense of the uncertainties during product development. In Making Sense Sophie Mützel traces this emergence of \"innovative breast cancer therapeutics\" from the late 1980s up to 2010, through the lens of the narratives of the involved actors. Combining theories of economic and cultural sociology, Mützel shows how stories are integral for the emergence of new markets; stories of the future create a market of expectations prior to any existing products; stories also help to create categories on what such a new market and its products are about. Making Sense uses thousands of press statements, media reports, scientific reports, and financial and industry analyses, and combines qualitative and large-scale computational text analyses, to illustrate these mechanisms, presenting a fresh view of how life-prolonging innovations can be turned into market products.

The Institute of Medicine (IOM) Forum on Neuroscience and Nervous System Disorders, in collaboration with the IOM Forum on Drug Discovery, Development, and Translation, convened a workshop on January 20-21, 2015, to explore policy changes that might increase private sector investment in research and development innovation that fills unmet medical needs for central nervous system (CNS) disorders. Workshop participants strategized about how to incentivize companies to fortify their CNS drug development programs, shrinking obstacles that currently deter ventures. Representatives from academia, government agencies, patient groups, and industry gathered to share information and viewpoints, and to brainstorm about budget-neutral policy changes that could help widen the pipeline toward drugs that address unmet needs for CNS disorders. This report summarizes the presentations and discussion of the workshop.

This handbook incisively explores challenges and opportunities that exist in efforts aimed at addressing inequities in mental health provision across the globe.Drawing on various disciplines across the humanities, psychology, and social sciences it charts the emergence of Global Mental Health as a field of study.

A Development Emergency: the title of this year's Global Monitoring Report, the sixth in an annual series, could not be more apt. The global economic crisis, the most severe since the Great Depression, is rapidly turning into a human and development crisis. No region is immune. The poor countries are especially vulnerable, as they have the least cushion to withstand events. The crisis, coming on the heels of the food and fuel crises, poses serious threats to their hard-won gains in boosting economic growth and reducing poverty. It is pushing millions back into poverty and putting at risk the very survival of many. The prospect of reaching the Millennium Development Goals (MDGs) by 2015, already a cause for serious concern, now looks even more distant. A global crisis must be met with a global response. The crisis began in the financial markets of developed countries, so the first order of business must be to stabilize these markets and counter the recession that the financial turmoil has triggered. At the same time, strong and urgent actions are needed to counter the impact of the crisis on developing countries and help them restore strong growth while protecting the poor. Global Monitoring Report 2009, prepared jointly by the staff of the World Bank and the International Monetary Fund, provides a development perspective on the global economic crisis. It assesses the impact on developing countries, their growth, poverty reduction, and other MDGs. And it sets out priorities for policy response, both by developing countries themselves and by the international community. This report also focuses on the ways in which the private sector can be better mobilized in support of development goals, especially in the aftermath of the crisis.

To control antimicrobial resistance (AMR) will require approaches to develop, share and preserve antibiotics that are scaled to the scientific, economic and ethical dimensions of the crisis. The three cooperative, interdisciplinary, international councils proposed here exemplify what this will require.To control antimicrobial resistance (AMR) will require approaches to develop, share and preserve antibiotics that are scaled to the scientific, economic and ethical dimensions of the crisis. The three cooperative, interdisciplinary, international councils proposed in this Comment by Carl Nathan exemplify what this will require.

Antimicrobial resistance (AMR) poses a significant global health threat, primarily stemming from its misuse and overuse in both veterinary and public healthcare systems. The consequences of AMR are severe, leading to more severe infections, increased health protection costs, prolonged hospital stays, unresponsive treatments, and elevated fatality rates. The impact of AMR is direct and far-reaching, particularly affecting the Sustainable Development Goals (SDGs), underscoring the urgency for concerted global actions to achieve these objectives. Disproportionately affecting underprivileged populations, AMR compounds their vulnerabilities, pushing them further into poverty. Moreover, AMR has ramifications for food production, jeopardizing sustainable agriculture and diminishing the livelihoods of farmers. The emergence of antibiotic-resistant bacteria in underprivileged areas heightens the risk of complications and mortality. Climate change further contributes to AMR, as evidenced by increased instances of foodborne salmonellosis and the development of antibiotic resistance, resulting in substantial healthcare costs. Effectively addressing AMR demands collaboration among governments, entrepreneurs, and the public sector to establish institutions and policies across all regulatory levels. Expanding SDG 17, which focuses on partnerships for sustainable development, would facilitate global antimicrobial stewardship initiatives, technology transfer, surveillance systems, and investment in vaccine and drug research. The World Bank's SDG database, tracking progress towards sustainable development, reveals a concerning picture with only a 15% success rate till 2023 and 48% showing deviation, underscoring a global gap exacerbated by the COVID-19 pandemic. Tackling AMR's global impact necessitates international cooperation, robust monitoring, and evaluation methods. The five priorities outlined guide SDG implementation, while impoverished countries must address specific challenges in their implementation efforts. Addressing AMR and its impact on the SDGs is a multifaceted challenge that demands comprehensive and collaborative solutions on a global scale.

Background Previous evidence shows that antibiotic use and antimicrobial resistance (AMR) spread are not always perfectly correlated within and between countries. We conducted an ecological analysis to evaluate how demographic, economic, governance, health, and freedom characteristics of 30 European countries contribute to antibiotic consumption and AMR. Methods Using three sources of data (World Bank DataBank, ECDC atlas, and the ESAC-Net database), we created a dataset of: 22 indicators of demographics, health, economic, governance, and freedom; AMR proportions for 25 combinations of pathogens and antibiotics; consumption of antibiotics in the community. We also computed five indexes of demographic, health, economic, governance, and freedom, and an aggregate AMR measure. Relationships between indexes, antibiotic consumption, and AMR proportions were explored using bivariate, multivariable, multivariate, and mediation analyses. Results Multivariate analysis identified three clusters of countries that mainly differed for demographic, health, governance, and freedom indexes. AMR proportion was lower in countries with better indexes ( p  < 0.001), but not necessarily with lower antibiotic consumption. In multivariable models including all five indexes, an increase in the governance index resulted in significant decreases of overall antibiotic consumption ( p  < 0.001) and AMR proportion ( p  = 0.006). Mediation analysis showed that the governance index had an indirect effect on AMR via reducing antibiotic consumption, which accounted only for 31.5% of the total effect. Conclusions These findings could be – at least partially – explained by the contagion theory, for which other factors contribute to high levels of AMR in countries with poor governance. As a result of this evidence, reducing antibiotic use alone is unlikely to solve the AMR problem, and more interventions are needed to increase governance efficiency at global level.

How hype, money, and bias can mislead the public into thinking that many worthless or unproven treatments are effective. Each week, people read about new and exciting cancer drugs. Some of these drugs are truly transformative, offering major improvements in how long patients live or how they feel—but what is often missing from the popular narrative is that, far too often, these new drugs have marginal or minimal benefits. Some are even harmful. In Malignant, hematologist-oncologist Dr. Vinayak K. Prasad writes about the many sobering examples of how patients are too often failed by cancer policy and by how oncology is practiced. Throughout this work, Prasad illuminates deceptive practices which • promote novel cancer therapies long before credible data are available to support such treatment; and • exaggerate the potential benefits of new therapies, many of which cost thousands and in some cases hundreds of thousands of dollars. Prasad then critiques the financial conflicts of interest that pervade the oncology field, the pharmaceutical industry, and the US Food and Drug administration. This is a book about how the actions of human beings—our policies, our standards of evidence, and our drug regulation—incentivize the pursuit of marginal or unproven therapies at lofty and unsustainable prices. Prasad takes us through how cancer trials are conducted, how drugs come to market, and how pricing decisions are made, asking how we can ensure that more cancer drugs deliver both greater benefit and a lower price. Ultimately, Prasad says, • more cancer clinical trials should measure outcomes that actually matter to people with cancer; • patients on those trials should look more like actual global citizens; • we need drug regulators to raise, not perpetually lower, the bar for approval; and • we need unbiased patient advocates and experts. This well-written, opinionated, and engaging book explains what we can do differently to make serious and sustained progress against cancer—and how we can avoid repeating the policy and practice mistakes of the past.

Antimicrobial resistance (AMR) is a “silent pandemic” that threatens the efficacy of antibiotics and other antimicrobials. It is imperative to take into account the ethical implications of how these resources are used and distributed as the world deals with this silent pandemic. This commentary discusses the ethical considerations surrounding the use and distribution of antibiotics in the age of resistance, including issues of equity and access, responsibility for antimicrobial stewardship, the environmental impact of antibiotic use, and the development and promotion of these drugs. The ethical implications of unequal access to antibiotics and the role of social determinants of health in shaping this access are considered, as well as the globalization of AMR and the need for multiple stakeholders to be involved in addressing this issue. The opportunities of antimicrobial stewardship programmes for optimising antibiotic use and reducing the emergence and spread of resistant bacteria, as well as the ethical implications of implementing such programmes, are examined. The potential environmental outcomes of antibiotic use and the ethical implications of these impacts are also discussed, as well as the role of the pharmaceutical industry in the development and promotion of these drugs, the potential conflicts of interest that may arise and the ethical dimension of resource transfer from Global North to Global South. This paper emphasises the significance of a holistic strategy to AMR that considers these ethical components, as well as the importance of preserving antibiotic efficacy for future generations.

Access to quality-assured medical products improves health and save lives. However, one third of the world’s population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually. National regulatory authorities are the key government institutions that promote access to quality-assured medicines and combat SF medical products but despite progress, regulatory capacity in LMICs is still insufficient. Continued and increased investment in regulatory system strengthening (RSS) is needed. We have therefore reviewed existing global normative documents and resources and engaged with our networks of global partners and stakeholders to identify three critical challenges being faced by NRAs in LMICs that are limiting access to medical products and impeding detection of and response to SF medicines. The challenges are; implementing value-added regulatory practices that best utilize available resources, a lack of timely access to new, quality medical products, and limited evidence-based data to support post-marketing regulatory actions. To address these challenges, we have identified seven focused strategies; advancing and leveraging convergence and reliance initiatives, institutionalizing sustainability, utilizing risk-based approaches for resource allocation, strengthening registration efficiency and timeliness, strengthening inspection capacity and effectiveness, developing and implementing risk-based post-marketing quality surveillance systems, and strengthening regulatory management of manufacturing variations. These proposed solutions are underpinned by 13 focused recommendations, which we believe, if financed, technically supported and implemented, will lead to stronger health system and as a consequence, positive health outcomes.