Analysis and reflection on the role of the 90-day oral toxicity study in European chemical risk assessment.

The 90-day toxicity study is one of the studies used in the safety assessment of food ingredients, medicines or other chemical substances. This paper reviews the current role of the 90-day oral toxicity study in European regulatory dossiers of chemicals by reviewing EU legislation and EU and OECD guidance documents. Regulatory provisions with regard to necessity, objectives and design of such 90-day toxicity studies vary between the different sectors addressed in this review. Most often the 90-day study is expected to be part of the standard test battery used for chemical risk assessment, without necessarily being a legal requirement and its objectives may vary between regulatory domains. Exceptions, when a 90-day study is not required are spelled out in the chemicals legislation and for food contact materials. The sectorial study design requirements of the 90-day toxicity study are very often embedded in the OECD TG 408 protocol. Differences in study objectives are not necessarily reflected in specific study designs. Considering the call for the reduction of using experimental animals for scientific purposes and the fact that a 90-day study may serve different purposes, consistency between the necessity to conduct such a study, its objectives and the study design to achieve these objectives may improve judicious use of laboratory animals. Thus there may be an opportunity to reflect and further optimise the design of in vivo toxicology studies, such as the 90-day study. This should be based on a systematic analysis of past studies and risk assessments.

Perceived health status in a comparative perspective: Methodological limitations and policy implications for Israel.

BACKGROUND: The perceived health status indicator included in the OECD Health Statistics suffers from severe methodological limitations related to data collection. Furthermore, this indicator is also included in the OECD's Better Life Index, thus distorting the total health score of some OECD countries, among them Israel. The purpose of this paper is to explore the erroneous use of OECD health data in Israel and to warn of its implications. METHODS: Analysis of data from the OECD Health Database, Better Life Index and the Israeli Central Bureau of Statistics, review of media reports and governmental documents concerning health measures, conversations and correspondence held with officials in the relevant organizations. RESULTS: OECD's perceived health status outcomes for Israel are biased upwards, resulting also in an upward bias of the Israeli overall health grade in the Better Life Index. This is due to the methodological differences between the OECD's standard survey questionnaire and the Israeli one. Yet, erroneous comparisons constantly appear in governmental documents and media reports, presenting health status in Israel in an excessive positive light. CONCLUSIONS: Data from the OECD Health Statistics and the Better Life Index are reaching policy makers and the public in a manner that potentially distorts professional and political discourse on health. This may lead to a decrease in the resources allocated to health based on a flawed comparison. In the long run, and no less serious, the systematic imprecision may detract from the reliability of authority reports in the eyes of the public. Caution is essential in dealing with health indices and international comparisons. The OECD and relevant national agencies should invest greater efforts in the consolidation of definitions and methodologies.

Does the Tail Wag the Dog? Abstainers, Alcohol Dependence, Heavy Episodic Drinkers and Total Alcohol Consumption.

AIMS: To study total alcohol consumption and its correlates, with an emphasis on the direction of causality. METHODS: The associations among total alcohol consumption, abstaining, alcohol dependence (AD) and heavy episodic drinking were compared in 29 Organization for Economic Cooperation and Development (OECD) countries in 2010. RESULTS: Either total alcohol consumption is determined by the number of abstainers and that of alcohol dependents, or the number of alcohol dependents is determined by total alcohol consumption. The number of non-dependent heavy episodic drinkers does not play a role. CONCLUSION: The number of alcohol dependents and abstainers seemingly determines total alcohol consumption and more efforts should be made to reduce AD. SHORT SUMMARY: The associations between total alcohol consumption, abstaining, alcohol dependence and heavy episodic drinking were compared in 29 OECD countries in 2010. The number of non-dependent heavy episodic drinkers does not play a role. The number of alcohol dependents and abstainers seemingly determine total alcohol consumption.

The Impact of Hospital Payment Schemes on Healthcare and Mortality: Evidence from Hospital Payment Reforms in OECD Countries.

In this study, aggregate-level panel data from 20 Organization for Economic Cooperation and Development countries over three decades (1980-2009) were used to investigate the impact of hospital payment reforms on healthcare output and mortality. Hospital payment schemes were classified as fixed-budget (i.e. not directly based on activities), fee-for-service (FFS) or patient-based payment (PBP) schemes. The data were analysed using a difference-in-difference model that allows for a structural change in outcomes due to payment reform. The results suggest that FFS schemes increase the growth rate of healthcare output, whereas PBP schemes positively affect life expectancy at age 65 years. However, these results should be interpreted with caution, as results are sensitive to model specification. Copyright © 2015 John Wiley & Sons, Ltd.

Alcohol affordability and alcohol demand: cross-country trends and panel data estimates, 1975 to 2008.

BACKGROUND: Relatively little is known about cross-country differences in alcohol affordability or factors that determine differences in affordability over time. This information is potentially important for alcohol policy, especially policies that focus on higher taxes or prices to reduce total alcohol consumption. This study estimates cross-country alcohol consumption relationships using economic models incorporating income and prices and alternative models based on alcohol affordability. The data and analysis are restricted to higher income countries. METHODS: Data for alcohol consumption per capita (ages 15+) are analyzed for 2 samples: first, 17 countries in the Organisation for Economic Co-operation and Development for the period 1975 to 2000; second, 22 countries in the European Union for the period from 2000 to 2008. Panel data models are utilized, with country and time fixed-effects to control for confounding influences. In economic demand models, covariates are real per capita income and real alcohol price indices. In affordability models, income is divided by prices to yield an index of alcohol affordability. RESULTS: Analysis of data trends reveals that much of the increase in affordability is due to rising real incomes, and not falling real prices. Economic models of demand perform slightly better statistically, but differences are not substantial as income and affordability are highly correlated. For both samples, exogenous rates of growth of alcohol consumption are negative. Price and income elasticities, on average, are within the range of prior estimates. Affordability elasticities are between 0.21 and 0.25. CONCLUSIONS: Although alcohol affordability is a valid concept statistically, its use in policy discussions tends to hide underlying causes of changes in affordability. A better approach is a comparison and analysis of trends and cross-country differences in real incomes and real alcohol prices together with the affordability index. Country-level analysis of income and price elasticities also is required.