Assessing commercial feasibility: a practical and ethical prerequisite for human clinical testing

This article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing. PMVs have been proposed as a potential solution for global health, based on a vision of immunizing the world against many infectious diseases. Such a vision depends on translating current knowledge in plant science and immunology into a potent vaccine that can be readily manufactured and distributed to those in need. But new biologics such as PMVs may fail to be manufactured due to financial or logistical reasons--particularly for orphan diseases without sufficient revenue incentive for industry investment--regardless of the effectiveness which might be demonstrated in human clinical testing. Moreover, all potential instruments of global health depend on translational agents well beyond the lab in order to reach those in need. A model compromising five criteria for commercial feasibility is suggested for inclusion by regulators and ethics review boards as part of the review process prior to approval of human clinical testing. Use of this model may help to facilitate safe and appropriate translational research and bring more immediate benefits to those in need.     

Social Structure, Crime and Criminalization: An Empirical Examination of the Conflict Perspective*

Using available data from a variety of secondary sources, this research examines the empirical validity of arguments maintained by conflict theorists about the interrelations among economic inequality, the incidence of crime, and the official crinrinalization of people through arrest. The reported findings, although not definitive, suggest that official criminalization may be a function of the structure of dominant/subordinate relations within populations, rather than the incidence of crime. These findings are dependent, however, on whether the incidence of crime is measured by official or unofficial statistics on criminal activity. The implications of the findings are discussed, and we conclude that they lend some support to conflict criminology and suggest that further aggregate tests using structural variables are desirable.     

Enhancing motivation, ability, and opportunity to process public relations messages

Drawing on the motivation, ability, and opportunity (M-A-O) model in the consumer psychology literature, this article suggests that motivation, ability, and opportunity provide theoretically rich frameworks to address strategies for effective communication with publics in general and inactive publics in particular. Examples of specific techniques frequently used in the construction of public relations messages are related to each of these three concepts. Implications for public relations practice and research are discussed.Kirk Hallahan is assistant professor in the Department of Journalism and Technical Communication at Colorado State University.     

A Note on the Growth of Research in Service Operations Management

We present an empirical assessment of the productivity of individuals and institutions in terms of service operations management (SOM) research. We reviewed five mainstream operations management journals over a 17‐year time period to generate a sample of 463 articles related to service operations. The results indicate that SOM research has been growing and key contributions are being made by an array of researchers and institutions.     

Effects of Cooking Smoke and Environmental Tobacco Smoke on Acute Respiratory Infections in Young Indian Children

Background Reliance on biomass for cooking and heating exposes many women and young children in developing countries to high levels of air pollution indoors. Environmental tobacco smoke also contributes to this indoor air pollution. This study estimates the effects of these sources of air pollution on acute respiratory infections (ARI) in children below 36 months of age in India.Methods The analysis is based on 29,768 children age 0–35 months included in India’s 1998–1999 National Family Health Survey (NFHS-2). Logistic regression is used to estimate effects.Results In NFHS-2, children living in households using only biomass fuels for cooking or heating are almost twice as likely to have suffered from ARI during the 2 weeks before interview as children in households using cleaner fuels (OR = 1.82; 95% CI: 1.58, 2.09). This effect is somewhat reduced when exposure to environmental tobacco smoke (ETS) and a number of other factors are statistically controlled (OR = 1.58; 95% CI: 1.28, 1.95). With these other variables controlled, children in households using a mix of biomass and cleaner fuels also have a higher risk of ARI than children in households using only cleaner fuels (OR = 1.41; 95% CI: 1.17, 1.70). With controls, the effect of biomass fuel use on ARI is stronger for boys (OR = 1.68; 95% CI: 1.26, 2.23) than for girls (OR = 1.49; 95% CI: 1.11, 2.01). The effect of ETS on ARI is also positive and significant, but smaller when other variables (including type of cooking fuel) are controlled (OR = 1.12; 95% CI: 1.01, 1.23). No modifying effects of cooking smoke and ETS are observed.Conclusions Findings support previous research showing positive effects of cooking smoke and ETS on ARI in young children. The relationship needs to be further investigated using more direct measures of smoke exposure and measures of outcome that are more specific to acute lower respiratory infections (ALRI), which are the most important component of overall ARI from a public health standpoint.Medical subject headings (MeSH) air pollution; indoor; biomass; smoke; environmental tobacco smoke; respiratory tract infections; child; India.Please address Correspondence to Vinod Mishra, DHR Division, ORC Macro, 11785 Beltsville Drive, Calverton, MD 20705, USA; e-mail: Vinod.Mishra@orcmacro.com     

Vital rates in India 1961-71 estimated from 1971 census data

Abstract In the last decade the increase in the population of India, while, of course, very large, was smaller than predicted by official forecasts. With the use of recent census and sample registration data - in the absence of age-specific rates and adequate vital statistics - this paper provides estimates of fertility and mortality through the reverse-survival and forward-projection methods. Birth rates are estimated as 40·5-42, death rates as 18-20, and life expectancy at birth as 45-46 years. Mortality decline had been smaller than forecast but more than during any comparable period in the past, even though current mortality levels, particularly infant mortality, are still high. Males continue to have a longer life expectation than females, with a difference that has widened in the past decade. The decline of between seven and ten per cent in the crude birth rate is largely due to changes in marital fertility and to some extent to changes in age and marital composition. Because of greater decline in death rates than birth rates, the 1961-71 decade shows a higher rate of population growth than previous periods.     

Posttraumatic stress disorder among foster care alumni: the role of race, gender, and foster care context

Little is known about the prevalence of posttraumatic stress disorder (PTSD) in adult alumni of foster care and its demographic and contextual correlates. This is one of the first studies to report on racial/ethnic and gender differences and the influence of foster care experiences (i.e., revictimization during foster care, placement change rate, and placement in kinship care) on past year PTSD. Findings revealed significant gender disparities and a moderating influence of kinship care on the relationship between gender and PTSD, as well as increased risk associated with a history of emotional and sexual abuse. Recommendations are made for clinical and systemic intervention.