Public investments in the clinical development of bedaquiline.

INTRODUCTION: In 2012, bedaquiline became the first new treatment from a novel class to be approved for tuberculosis in nearly five decades and is now a core component of the standard of care for multidrug-resistant tuberculosis. In addition to the originator pharmaceutical company, Janssen, a range of governmental and non-profit entities have contributed to the development of bedaquiline. MATERIALS AND METHODS: We identified various avenues of public investments in the development of bedaquiline: direct funding of clinical trials and a donation programme, tax credits and deductions, and revenues resulting from the priority review voucher (PRV) awarded to the originator. Data on investments were gathered through contact with study leads and/or funders; for non-responses, published average costs were substituted. The originator company's expenses were estimated by similar methods. Tax credits and deductions were calculated based on estimated originator trial costs and donation expenses. The value of the PRV was estimated by application of a published model. RESULTS: Public contributions through clinical trials funding were estimated at US$109-252 million, tax credits at US$22-36 million, tax deductions at US$8-27 million, administration of a donation programme at US$5 million, PRV revenues at US$300-400 million. Total public investments were US$455-747 million and originator investments were US$90-240 million (if capitalized and risk-adjusted, US$647-1,201 million and US$292-772 million, respectively). CONCLUSIONS: Estimating the investments in the development of a medicine can inform discussions regarding fair pricing and future drug development. We estimated that total public investments exceeded the originator's by a factor of 1.6-5.1.

Funding for tuberculosis research-an urgent crisis of political will, human rights, and global solidarity.

Tuberculosis (TB) killed more people in 2015 than any other single infectious agent, but funding for research to develop better prevention, diagnosis, and treatment methods for TB declined to its lowest level in 7 years. TB research and development (R&D) is woefully underfunded, a situation best viewed as a crisis of political will and a failure on the part of governments to see unmet innovation needs in the TB response as a human rights issue requiring immediate action. Over 60% of available money for TB R&D comes from public sources, and 67% of public money comes from a single country: the USA. The election of Donald Trump to the US presidency in November 2016 has introduced great uncertainty into the support that science generally, and TB research in particular, will receive in the coming years. Advocacy on the part of all actors-from civil society to TB-affected communities to scientists themselves-is urgently needed to increase US government support for TB research moving forward.

Tobacco retail clustering around schools in New York City: examining "place" and "space".

This paper investigates whether tobacco retailers cluster around schools in New York City. Retail clustering is assessed through two measures: (1) proximity of retailers to schools and (2) density of retailers around schools. Through exploratory spatial statistics and OLS regression, we analyze how retailer density and proximity to schools vary in relation to socio-demographic differences across NYC community districts. As a secondary objective, we test whether patterns of retail clustering differ when assessed by proximity versus density. We identify areas of positive spatial autocorrelation in lower Manhattan and the Bronx, indicating that some NYC community districts have significantly higher density of tobacco retailers around schools than others. The density and proximity of tobacco retailers to schools co-vary with population density, commercial land use and broad indicators of social disadvantage including health insurance coverage. We also find that patterns of retail clustering differ when assessed using either density or proximity, suggesting that land use interventions that restrict tobacco retail proximity to schools might not address retailer density around schools.