Continuous prophylaxis with recombinant factor IX Fc fusion protein and conventional recombinant factor IX products: comparisons of efficacy and weekly factor consumption

Background: Continuous prophylaxis for patients with hemophilia B requires frequent injections that are burdensome and that may lead to suboptimal adherence and outcomes. Hence, therapies requiring less-frequent injections are needed. In the absence of head-to-head comparisons, this study compared the first extended-half-life-recombinant factor IX (rFIX) product—recombinant factor IX Fc fusion protein (rFIXFc)—with conventional rFIX products based on annualized bleed rates (ABRs) and factor consumption reported in studies of continuous prophylaxis.

Methods: This study compared ABRs and weekly factor consumption rates in clinical studies of continuous prophylaxis treatment with rFIXFc and conventional rFIX products (identified by systematic literature review) in previously-treated adolescents and adults with moderate-to-severe hemophilia B. Meta-analysis was used to pool ABRs reported for conventional rFIX products for comparison. Comparisons of weekly factor consumption were based on the mean, reported or estimated from the mean dose per injection.

Results: Five conventional rFIX studies (injections 1 to >3 times/week) met the criteria for comparison with once-weekly rFIXFc reported by the B-LONG study. The pooled mean ABR for conventional rFIX was slightly higher than but comparable to rFIXFc (difference=0.71; p?=?0.210). Weekly factor consumption was significantly lower with rFIXFc than in conventional rFIX studies (difference in means?=?42.8–74.5?IU/kg/week [93–161%], p?Conclusion: Comparisons of clinical study results suggest weekly injections with rFIXFc result in similar bleeding rates and significantly lower weekly factor consumption compared with more-frequently-injected conventional rFIX products. The real-world effectiveness of rFIXFc may be higher based on results from a model of the impact of simulated differences in adherence.     

Karma-Yoga: The Indian Model of Moral Development

A comprehensive model of moral development must encompass moral sensitivity, moral reasoning, moral motivation, and moral character. Western models of moral development have often failed to show validity outside the culture of their origin. We propose Karma-Yoga, the technique of intelligent action discussed in the Bhagawad Gita as an Indian model for moral development. Karma-Yoga is conceptualized as made up of three dimensions viz. duty-orientation, indifference to rewards, and equanimity. Based on survey results from 459 respondents from two large Indian organizations, we show that the dimensions of Karma-Yoga are related to moral sensitivity, moral motivation, and moral character.     

Investor perceptions of the earnings quality consequences of hiring an affiliated auditor

The Sarbanes–Oxley Act (SOX) requires that firms wait 1 year before hiring an individual employed as a member of the external audit team. SOX’s intent is to reduce the perceived loss of auditor independence due to affiliated hiring. SOX also requires fully independent audit committees and disclosure of directors with financial expertise. Using a sample of financial executive hires during the pre-SOX period, we find that earnings response coefficients (ERCs) decline following hires of individuals recently employed by the firm’s external auditor, but ERCs do not decline following hires not recently employed by the external auditor. We also find smaller ERC declines following affiliated hires for firms with audit committee compositions consistent with subsequently imposed SOX requirements. Further investigation using measures of earnings quality suggests that differences in ERC changes are attributable to perceived, rather than real, changes in earnings quality following affiliated hires.     

Budget Type and Performance — The Moderating Effect of Uncertainty

Calls for improvements to traditional yearly corporate budgeting practices have a common thread, the failure of these practices to provide adequate plans in uncertain environments. Rolling budgets that require continuously updated forecasts have been suggested as a means to improve the traditional budget process. We hypothesise that when the environment is highly uncertain, learning effects from rolling forecasting result in superior performance. In the same environment, traditional budgeting results in poorer performance because there is no systematic method for exploring and understanding environmental uncertainty. Alternatively, rolling forecasting causes inferior performance in low uncertainty conditions because commitment to the budget goal is more important than the benefits of learning from forecasting.     

Measures for Dealing with Competence and Integrity Violations of Interorganizational Trust at the Corporate and Operating Levels of Organizational Hierarchy

We examine how partners in an interorganizational relationship can repair violated trust, and if that is impossible, how they can preserve the collaborative relationship. We also consider under what circumstances exit from the relationship is the only viable option. We propose that the effectiveness of legalistic and non-legalistic measures in response to a trust violation is a function of the hierarchical level at which the violation occurred (corporate vs. operating), the character of the violation (competence vs. integrity), the frequency and severity with which it occurred, the organizational context in which boundary spanners are embedded, and the degree of dependence between the partners. Based on these factors, we explore how the way in which violation of trust is dealt with at one hierarchical level might affect trust at the other level. Our theoretical model reveals that prior findings on trust repair in inter-personal context may not hold in the interorganizational context.     

Impact of MBA Education on Students’ Values: Two Longitudinal Studies

The impact of 2-year residential fulltime MBA program on students’ values was studied using a longitudinal design and data collected over 7 years from a business school in India. Values were measured when students entered the program, and again when they graduated. Sample in Study 1 consisted of 229 students from three consecutive graduating classes. Rank-order or ipsative measure of values was used. Results of matched sample t-tests show that self-oriented values like a comfortable life and pleasure become more important and others-oriented values like being helpful and polite become less important over 2 years. The moderating role of sex and functional specialization are also analyzed. Study 2 used a non-ipsative measure of values and a sample of 138 students from two consecutive graduating classes. Results show that management education enhances self-monitoring and importance of self-oriented values and reduces the importance of others-oriented values. The effect on both sets of values remains significant even after controlling for self-monitoring.     

Re-examination of the historical equity risk premium in Australia

In light of the ongoing debate over the value of the equity risk premium, its increasing use in the regulatory setting, and the impact of dividend imputation on the premium, this paper presents a timely new look at the historical equity risk premium in Australia, and provides an improved understanding of the historical record. We document concerns about data quality that become increasingly important the further back in time one looks. In particular, there are sufficient question marks over the quality of data prior to 1958 to warrant any estimates based thereon to be treated with caution. Accordingly, we present a new set of estimates of the historical equity risk premium corresponding to periods of increasing data quality but of decreasing sample size. Relative to bonds (bills), the equity premium has averaged 6.3 per cent (6.8 per cent) per annum over 1958–2005, which is a period of relatively good data quality. Together with other results in the paper, the findings reveal a historical estimate that is substantially less than widely cited historical studies would otherwise indicate. We reconcile prior evidence through documenting a dividend adjustment that has typically been overlooked. We also provide estimates that incorporate an adjustment for imputation credits.