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.     

Book Review: Calvinism Incorporated: Welsh Immigrants on Ohio's Industrial Frontier. By Knowles,Anne Kelly. Chicago: University of Chicago Press (University of Chicago Geography Research Paper,No. 240), 1997. Paper,ISBN: 0-226-44853-3

Qualitative Sociology -     

Qualities of Peer Relations on Social Networking Websites: Predictions From Negative Mother–Teen Interactions

This study examined associations between characteristics of teenagers' relationships with their mothers and their later socializing behavior and peer relationship quality online. At age 13, teenagers and their mothers participated in an interaction in which mothers' and adolescents' behavior undermining autonomy and relatedness was observed and indicators of teens' depressive symptoms and social anxiety were assessed. At age 20, youth self‐reported on their online behaviors, youths' social networking webpages were observationally coded to assess peer relationship quality online, and symptoms of depression and social anxiety were reassessed. Results suggested that problematic mother–teen relationships were predictive of youths' later preference for online communication and greater likelihood of forming a friendship with someone met online, yet poorer quality in online relationships. Findings are discussed within a developmental framework suggesting the importance of considering youths' family interactions during early adolescence as predictors of future online socializing behavior and online interactions with peers.     

An Empirical Study of Personality Disorders Among Treatment-Seeking Problem Gamblers

The primary aims of this study were to examine the prevalence of personality disorders in problem gamblers, to explore the relationship between personality disorders and problem gambling severity, and to explore the degree to which the psychological symptoms highlighted in the biosocial developmental model of borderline personality disorder (impulsivity, distress tolerance, substance use, PTSD symptoms, psychological distress and work/social adjustment) are associated with problem gambling. A secondary aim was to explore the strength of the relationships between these symptoms and problem gambling severity in problem gamblers with and without personality disorder pathology. Participants were 168 consecutively admitted problem gamblers seeking treatment from a specialist outpatient gambling service in Australia. The prevalence of personality disorders using the self-report version of the Iowa Personality Disorders Screen was 43.3 %. Cluster B personality disorders, but not Cluster A or C personality disorders, were associated with problem gambling severity. All psychological symptoms, except alcohol and drug use, were significantly higher among participants with personality disorder pathology compared to those without. Finally, psychological distress, and work and social adjustment were significantly associated with problem gambling severity for problem gamblers with personality disorder pathology, while impulsivity, psychological distress, and work and social adjustment were significantly associated with problem gambling severity for those without personality disorder pathology. High rates of comorbid personality disorders, particularly Cluster B disorders, necessitate routine screening in gambling treatment services. More complex psychological profiles may complicate treatment for problem gamblers with comorbid personality disorders. Future research should examine the applicability of the biosocial developmental model to problem gambling in community studies.     

Predictions From Early Adolescent Emotional Repair Abilities to Functioning in Future Relationships

This study examined adolescents' ability to utilize emotional repair—to actively change negative moods to more positive moods—as a predictor of the quality of their developing peer and romantic relationships over time. Utilizing observational data and partners' reports, adolescents (N = 184), their close peers, and their romantic partners were followed from ages 15–19. Adolescents with initially stronger emotional repair abilities were rated as increasingly socially competent over time, and both displayed and experienced increasingly positive interactive behaviors with close peers over time. These adolescents' romantic partners also reported more positive relationships, with enhanced communication, and fewer critical, blaming, or hostile interactions. Implications for the role of emotional repair abilities in the development of successful relationships during adolescence are discussed.     

Systematic Interviewing Microskills and Neuroscience: Developing Bridges between the Fields of Communication and Counseling Psychology

Originating in 1966-68, Microcounseling was the first video-based listening program and its purposes and methods overlap with the communications field. This article presents history, research, and present applications in multiple fields nationally and internationally. Recent neuroscience and neurobiology research is presented with the important point—“counseling and communication change the brain and encourage the development of new neural networks.— Multicultural issues are important in the microskills framework. Over 500 databased Microcounseling studies exist with translations in 21 languages. The authors suggest that the communication studies field might wish to consider itself also a mental health profession as the teaching of listening skills and effective communication is central to well-being. Furthermore, communication studies can do much to increase multicultural understanding and cross-cultural communication.     

Numerical evaluation of observed sojourn time distributions for a single ion channel incorporating time interval omission

The dynamical aspects of single ion channel gating can be modelled by a semi-Markov process. There is aggregation of states, corresponding to the receptor channel being open or closed, and there is time interval omission, brief sojourns in either the open or closed classes of states not being detected. This paper is concerned with the computation of the probability density functions of observed open (closed) sojourn-times incorporating time interval omission. A system of Volterra integral equations is derived, whose solution governs the required density function. Numerical procedures, using iterative and multistep methods, are described for solving these equations. Examples are given, and in the special case of Markov models results are compared with those obtained by alternative methods. Probabilistic interpretations are given for the iterative methods, which also give lower bounds for the solutions.