Does the development of new medicinal products in the European Union address global and regional health concerns?

<p>Abstract</p> <p>Background</p> <p>Since 1995, approval for many new medicinal products has been obtained through a centralized procedure in the European Union. In recent years, the use of summary measures of population health has become widespread. We investigated whether efforts to develop innovative medicines are focusing on the most relevant conditions from a global public health perspective.</p> <p>Methods</p> <p>We reviewed the information on new medicinal products approved by centralized procedure from 1995 to 2009, information that is available to the public in the European Commission Register of medicinal products and the European Public Assessment Reports from the European Medicines Agency. Morbidity and mortality data were included for each disease group, according to the Global Burden of Disease project. We evaluated the association between authorized medicinal products and burden of disease measures based on disability-adjusted life years (DALYs) in the European Union and worldwide.</p> <p>Results</p> <p>We considered 520 marketing authorizations for medicinal products and 338 active ingredients. New authorizations were seen to increase over the period analyzed. There was a positive, high correlation between DALYs and new medicinal product development (ρ = 0.619, p = 0.005) in the European Union, and a moderate correlation for middle-low-income countries (ρ = 0.497, p = 0.030) and worldwide (ρ = 0.490, p = 0.033). The most neglected conditions at the European level (based on their attributable health losses) were neuropsychiatric diseases, cardiovascular diseases, respiratory diseases, sense organ conditions, and digestive diseases, while globally, they were perinatal conditions, respiratory infections, sense organ conditions, respiratory diseases, and digestive diseases.</p> <p>Conclusions</p> <p>We find that the development of new medicinal products is higher for some diseases than others. Pharmaceutical industry leaders and policymakers are invited to consider the implications of this imbalance by establishing work plans that allow for the setting of future priorities from a public health perspective.</p

Public health research systems in the European union

<p>Abstract</p> <p>Background</p> <p>Strengthening health research is an important objective for international health organisations, but there has been less attention to support for health research in Europe. We describe the public-health (population and organisational level) research systems in the 27 European Union countries.</p> <p>Methods</p> <p>We developed a typology for describing health research structures based on funding streams and strategies. We drew data from internet sources and asked country informants to review these for consistency and completeness. The structures were described as organograms and narratives in country profiles for each of the 27 EU member states. National public-health research structures included public and independent funding organisations, 'mixed' institutions (which receive funds, and both use and allocate them) and provider institutions.</p> <p>Results</p> <p>Most health research is funded through ministries of science or science councils (and sometimes foundations), while parliaments and regions may also contribute. National institutes of public health are usually funded by ministries of health. Many national research organisations both determine research programmes and undertake health research, but there is a move towards public-health sciences within the universities, and a transition from internal grants to competitive funding. Of 27 national research strategies, 17 referred to health and 11 to public health themes. Although all countries had strategies for public health itself, we found little coherence in public-health research programmes. The European Commission has country contact points for both EU research and health programmes, but they do not coordinate with national health-research programmes.</p> <p>Conclusions</p> <p>Public-health research is broadly distributed across programmes in EU countries. Better understanding of research structures, programmes and results would improve recognition for public health in Europe, and contribute to practice. EU ministries of health should give greater attention to national public-health research strategies and programmes, and the European Union and the World Health Organisation can provide coordination and support.</p

Antimicrobial peptides as novel anti-tuberculosis therapeutics

"Available online 24 May 2016"Tuberculosis (TB), a disease caused by the human pathogen Mycobacterium tuberculosis, has recently joined HIV/AIDS as the world's deadliest infectious disease, affecting around 9.6 million people worldwide in 2014. Of those, about 1.2 million died from the disease. Resistance acquisition to existing antibiotics, with the subsequent emergence of Multi-Drug Resistant mycobacteria strains, together with an increasing economic burden, has urged the development of new anti-TB drugs. In this scope, antimicrobial peptides (AMPs), which are small, cationic and amphipathic peptides that make part of the innate immune system, now arise as promising candidates for TB treatment. In this review, we analyze the potential of AMPs for this application. We address the mechanisms of action, advantages and disadvantages over conventional antibiotics and how problems associated with its use may be overcome to boost their therapeutic potential. Additionally, we address the challenges of translational development from benchside to bedside, evaluate the current development pipeline and analyze the expected global impact from a socio-economic standpoint. The quest for more efficient and more compliant anti-TB drugs, associated with the great therapeutic potential of emerging AMPs and the rising peptide market, provide an optimal environment for the emergence of AMPs as promising therapies. Still, their pharmacological properties need to be enhanced and manufacturing-associated issues need to be addressed.Portuguese Foundation for Science and Technology (FCT) - UID/ BIO/04469/2013 unit ; COMPETE 2020 (POCI-01-0145-FEDER- 006684) ; SFRH/BPD/64958/2010Project RECI/BBB-EBI/0179/2012 (FCOMP-01-0124-FEDER-027462

Modelling ecological and human exposure to POPs in Venice lagoon - Part II: Quantitative uncertainty and sensitivity analysis in coupled exposure models

The study is focused on applying uncertainty and sensitivity analysis to support the application and evaluation of large exposure models where a significant number of parameters and complex exposure scenarios might be involved. The recently developedMERLIN-Expo exposure modelling tool was applied to probabilistically assess the ecological and human exposure to PCB 126 and 2,3,7,8-TCDD in the Venice lagoon (Italy). The 'Phytoplankton', 'Aquatic Invertebrate', 'Fish', 'Human intake' and PBPK models available in MERLIN-Expo library were integrated to create a specific food web to dynamically simulate bioaccumulation in various aquatic species and in the human body over individual lifetimes from 1932 until 1998. MERLIN-Expo is a high tier exposure modelling tool allowing propagation of uncertainty on the model predictions through Monte Carlo simulation. Uncertainty in model output can be further apportioned between parameters by applying built-in sensitivity analysis tools. In this study, uncertainty has been extensively addressed in the distribution functions to describe the data input and the effect on model results by applying sensitivity analysis techniques (screening Morris method, regression analysis, and variance-based method EFAST). In the exposure scenario developed for the Lagoon of Venice, the concentrations of 2,3,7,8-TCDD and PCB 126 in human blood turned out to be mainly influenced by a combination of parameters (half-lives of the chemicals, body weight variability, lipid fraction, food assimilation efficiency), physiological processes (uptake/elimination rates), environmental exposure concentrations (sediment, water, food) and eating behaviours (amount of food eaten). In conclusion, this case study demonstrated feasibility of MERLIN-Expo to be successfully employed in integrated, high tier exposure assessment. (C) 2016 Elsevier B.V. All rights reserved

Dialogue guides awareness and understanding of science: an essay on different goals of dialogue leading to different science communication approaches

Dialogue has become a buzzword in science communication. Many governmental initiatives involving information transfer use dialogue as a selling point. We have, for example, a dialogue on genetic manipulation, a dialogue on the scientific future of Europe, a dialogue on food safety. Dialogue has almost become a communication target on its own, beside such things as public understanding or awareness of science. Dialogue is, however, just a technique, a method that can be used in any modality of science communication to serve any of its goals. New developments in the growing use of dialogue should therefore be considered as part of science communication as a whole. In this essay we discuss the various operationalizations of dialogue for different science communication modalities and goals, based on different notions of science. Dialogue offers various possibilities for science communication. There is an important difference between dialogue with a functional goal and dialogue with a conceptual goal. This distinction and its implications are based on our recent study on effective biomedical science communication on predictive DNA diagnostics