Telcagepant is a new oral treatment for migraine

Background : Migraine is a common cause of disability. Many subjects (30 – 40%) do not respond to the 5-HT 1B/1D agonists (the triptans) commonly used in the treatment of migraine attacks. Calcitonin gene-related protein (CGRP) receptor antagonism is a new approach to the treatment of migraine attacks. Objectives/methods : This evaluation is of a Phase III clinical trial comparing telcagepant, an orally active CGRP receptor antagonist, with zolmitriptan in subjects during an attack of migraine. Results : Telcagepant 300 mg has a similar efficacy to zolmitriptan in relieving pain, phonophobia, photophobia, and nausea. Telcagepant was better tolerated than zolmitriptan. Conclusions : The initial Phase III clinical trial results with telcagepant are promising but several further clinical trials are needed to determine the place of telcagepant in the treatment of migraine attacks

Tesofensine : a novel potent weight loss medicine

Background: The incidence of obesity is increasing; this is of major concern, as obesity is associated with cardiovascular disease, stroke, type 2 diabetes, respiratory tract disease, and cancer. Objectives/methods: This evaluation is of a Phase II clinical trial with tesofensine in obese subjects. Results: After 26 weeks, tesofensine caused a significant weight loss, and may have a higher maximal ability to reduce weight than the presently available anti-obesity agents. However, tesofensine also increased blood pressure and heart rate, and may increase psychiatric disorders. Conclusions: It is encouraging that tesofensine 0.5 mg may cause almost double the weight loss observed with sibutramine or rimonabant. As tesofensine and sibutramine have similar pharmacological profiles, it would be of interest to compare the weight loss with tesofensine in a head-to-head clinical trial with sibutramine, to properly assess their comparative potency. Also, as teso fensine 0.5 mg increases heart rate, as well as increasing the incidence of adverse effects such as nausea, drug mouth, flatulence, insomnia, and depressed mode, its tolerability needs to be further evaluated in large Phase III clinical trials.

Anti-cancer activity of zoledronic acid in breast cancer

Background: Zoledronic acid is used to prevent the bone loss associated with antioestrogen treatments in subjects with breast cancer. Preclinical studies suggest that zoledronic acid may have anticancer activity in its own right. This anticancer possibility with zoledronic acid has not been investigated extensively in clinical trials. Objectives/methods: This evaluation is of a large clinical trial that investigated the effect of zoledronic acid on cancer outcomes in premenopausal women with breast cancer. Results: The trial showed that after 4 years, 94.0% of subjects who were treated with zoledronic acid were disease-free compared with 90.8% of those not treated with zoledronic acid. Recurrence survival was a secondary end point; this occurred in 94.0% with, and 90.9% without, zoledronic acid treatment. Conclusions: Zoledronic acid does have anticancer activity in premenopausal women with cancer.

Is liraglutide or exenatide better in type 2 diabetes?

Background: Subjects with type 2 diabetes have high circulating levels of glucose. Glucagon-like peptide-1 (GLP-1) is an intestinal hormone that has a major role in glucose homeostasis. Exenatide and liraglutide are both agonists at the GLP-1 receptor, and are effective at reducing circulating glucose levels (measured as HbA1c levels), but they have not been compared. Objectives/methods: This evaluation is of a clinical trial comparing liraglutide once a day with exenatide twice a day in subjects with type 2 diabetes. Results: In the Liraglutide Effect and Action in Diabetes (LEAD)-6 trial, subcutaneous liraglutide 1.8 mg once a day was compared with exenatide 10 μg twice a day. The primary efficacy outcome was change in HbA1c levels, and this was significantly greater with liraglutide (1.12%) than with exenatide (0.79%). Liraglutide and exenatide had similar small abilities to reduce body weight, blood pressure and LDL-cholesterol. Conclusions: Liraglutide was more effective than exenatide for overall glycaemic control in subjects with type 2 diabetes. However, this is only true for the preparations and doses tested, that is liraglutide 1.8 mg once weekly and exenatide 10 μg b.i.d., and may not apply when the comparison is undertaken with the new longer-lasting preparation of exenatide once weekly.

Good clinical endpoints with denosumab in osteoporosis and cancer

Background: Bone loss associated with low oestrogen levels in postmenopausal women, and with androgen deprivation therapy in men with hormone-sensitive prostate cancer, result in an increased incidence of fractures. Denosumab has been shown to increase bone mineral density in these two conditions. Objectives/methods: The objective of this evaluation is to review the clinical trials that have studied clinical endpoints in these conditions. Results: FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) was an International Phase III clinical trial that measured the clinical endpoints with denosumab in postmenopausal women with osteoporosis. At 36 months, new vertebral fractures had occurred in 7.2% of subjects in the placebo group and this was lowered to 2.3% of subjects treated with denosumab. HALT (Denosumab Hormone Ablation Bone Loss Trial) studied the clinical endpoints in men with non-metastatic prostate cancer receiving androgen-deprivation therapy. The incidence of vertebral fractures was significantly lower in the denosumab group (1.5%) than in the placebo group (3.9%). The incidence of adverse effects with denosumab in both clinical trials was low. Conclusions: Denosumab reduces the incidence of fractures in postmenopausal women with osteoporosis and in men with non-metastatic prostate cancer receiving androgen-deprivation therapy. Denosumab is well tolerated.

Elicitator : an expert elicitation tool for regression in ecology

Expert elicitation is the process of retrieving and quantifying expert knowledge in a particular domain. Such information is of particular value when the empirical data is expensive, limited, or unreliable. This paper describes a new software tool, called Elicitator, which assists in quantifying expert knowledge in a form suitable for use as a prior model in Bayesian regression. Potential environmental domains for applying this elicitation tool include habitat modeling, assessing detectability or eradication, ecological condition assessments, risk analysis, and quantifying inputs to complex models of ecological processes. The tool has been developed to be user-friendly, extensible, and facilitate consistent and repeatable elicitation of expert knowledge across these various domains. We demonstrate its application to elicitation for logistic regression in a geographically based ecological context. The underlying statistical methodology is also novel, utilizing an indirect elicitation approach to target expert knowledge on a case-by-case basis. For several elicitation sites (or cases), experts are asked simply to quantify their estimated ecological response (e.g. probability of presence), and its range of plausible values, after inspecting (habitat) covariates via GIS.

Australian media ethics regime and ethical risk management

Media organizations are simultaneously key elements of an effective democracy and, for the most part, commercial entities seeking success in the market. They play an essential role in the formation of public opinion and the influence on personal choices. Yet most of them are commercial enterprises seeking readers or viewers, advertising, favorable regulatory decisions for their media, and other assets. This creates some intrinsic difficulties and produces some sharp tensions within media ethics. In this article, we examine such tensions—in theory and practice. We then consider the feasibility of introducing an ethics regime to the media industry—a regime that would be effective in a deregulated environment in protecting public interest and social responsibility. In the article, we also outline a rationale and a methodology for the institutionalization of an acceptable and workable media ethics regime that aims to protect the integrity of the industry in a future of undoubtedly increasing commercial pressure.

Building an effective trade practices commission : the role of Professor Robert Baxt AO

Bob Baxt, the third Chairman of the Trade Practices Commission, served for a single three year term from 1988 to 1991. He followed Bob McComas, who had deliberately adopted a non-litigious approach to preserving the competitive process, believing that he understood business as an insider and that much of what it did was not anti-competitive, when correctly viewed. Baxt was far more pro-active in his approach, and more closely aligned with that of the first Chairman, Ron Bannerman. Baxt sought to push the frontiers of investigation and precedent, and perhaps, more significantly, sought to influence his Ministers, the government, public servants and public opinion about the need to expand the coverage of the Trade Practices Act, increase penalties and properly resource the Commission so that it could perform its assigned roles. This article examines Baxt’s early and on-going role in teaching Australian students and professionals through his interdisciplinary Trade Practices Workshops, the political context of Baxt’s tenure, including his relations with the Attorney-General ,Michael Duffy, and his skilful handling of the Queensland Wire case.

Conference on urban issues

Personal reflections and opinion on the Australian Aboriginal and Torres Strait Islander Studies (AIATSIS) National Indigenous Studies Conference, Perspectives on Urban life: Connections and Reconnections was held in Canberra from 28 September – 1 October 2009.

Understanding legitimacy in a changing global economy

In a knowledge economy where technologically mediated information plays an important role, greater understanding is required of its impact on organisational sustainability. This paper examines the link between mediated information within a global economy and its relationship to a key to long-term organisational success– legitimacy. Aligning organisational legitimacy and the demands of a range of internal and external stakeholders is a central concern for managers when challenges to legitimacy continue to arise. Particularly during times of internally or environmentally driven change, challenges are created for managers seeking to ensure their organisation avoids questioning about its legitimacy. This paper presents the proposition that the perceptions of collective opinion derived from mass media provide a lens to a global world upon which managers base decisions to protect and repair organisational legitimacy. Legitimacy is determined from a broad social arena that can cross national and international boundaries (Lomi, 2000). Experience of legitimacy concerns, therefore, are often outside the traditional realms of managerial knowledge, and experience and of local business association networks (Aldrich, 1999). While the organisational landscape has been changing, at the same time, mass media have increased the focus on bringing news about events, and interpretations of events, from a broad and even global social area (Mutz, 1998). In addition, electronically facilitated media have exposed both organisational stakeholders and managers to views and interpretations of the world more quickly and more explicitly than in previous times. This paper proposes a relationship between perceptions of collective opinion derived from mass media and organisational legitimacy in such an environment.

United States still no closer to database legislation

Last year European Intellectual Property Review published an article comparing the latest version of the proposed US database legislation, the Collections of Information Antipiracy Bill with the UK's Copyright and Rights in Database Regulations 1997. Subsequently a new US Bill, the Consumer and Investor Access to Information Act has emerged, the Antipiracy Bill has been amended and much debate has occurred, but the US seems no closer to enacting database legislation. This article briefly outlines the background to the US legislative efforts, examines the two Bills and draws some comparisons with the UK Regulations. A study of the US Bills clearly demonstrates the starkly divided opinion on database protection held by the Bills' proponents and the principal lobby groups driving the legislative efforts: the Antipiracy Bill is very protective of database producers' interests, whereas the Access Bill is heavily user-oriented. If the US experience is any indication there will be a long horizon involved in achieving any consensus on international harmonisation of this difficult area.

The nine lives of Vietnam's new competition law

Vietnam's present draft of the proposed new Law on Competition is currently in its ninth version. Although there is a need to enact legislation as quickly as possible, Vietnam cannot rush the drafting process. Under its Bilateral Trade Agreement with the USA, Vietnam has committed to improve the quality of its laws and consistency of its legislative framework. Since the Law on Competition will be fundamental in establishing the legal framework for a more coherent and effective competition regime, and will have profound influences on Vietnam's objective of becoming a socialist-oriented market economy, its provisions must be well constructed and well considered, and this takes time. This article shows how the proposed Law is being crafted as compared to older drafts which sheds light on changes in policy during the drafting process. Where possible, the Draft is also compared with the laws in other jurisdictions for any assistance they might lend. In this author's opinion not all the changes are positive but any defects in the draft are not intractable and can be remedied prior to promulgation.

Acute and long-term effects of exercise on appetite control: Is there any benefit for weight control?

Purpose of review: To examine the relationship between energy intake, appetite control and exercise, with particular reference to longer term exercise studies. This approach is necessary when exploring the benefits of exercise for weight control, as changes in body weight and energy intake are variable and reflect diversity in weight loss. Recent findings: Recent evidence indicates that longer term exercise is characterized by a highly variable response in eating behaviour. Individuals display susceptibility or resistance to exercise-induced weight loss, with changes in energy intake playing a key role in determining the degree of weight loss achieved. Marked differences in hunger and energy intake exist between those who are capable of tolerating periods of exercise-induced energy deficit, and those who are not. Exercise-induced weight loss can increase the orexigenic drive in the fasted state, but for some this is offset by improved postprandial satiety signalling. Summary: The biological and behavioural responses to acute and long-term exercise are highly variable, and these responses interact to determine the propensity for weight change. For some people, long-term exercise stimulates compensatory increases in energy intake that attenuate weight loss. However, favourable changes in body composition and health markers still exist in the absence of weight loss. The physiological mechanisms that confer susceptibility to compensatory overconsumption still need to be determined.

Thinking Collaboratively about the Peer-Review Process for Journal- Article Publication

In this conversation, Kevin K. Kumashiro shares his reflections on challenges to publishing anti-oppressive research in educational journals. He then invites eight current and former editors of leading educational research journals--William F. Pinar, Elizabeth Graue, Carl A. Grant, Maenette K. P. Benham, Ronald H. Heck, James Joseph Scheurich, Allan Luke, and Carmen Luke--to critique and expand on his analysis. Kumashiro begins the conversation by describing his own experiences submitting manuscripts to educational research journals and receiving comments by anonymous reviewers and journal editors. He suggests three ways to rethink the collaborative potential of the peer-review process: as constructive, as multilensed, and as situated. The eight current and former editors of leading educational research journals then critique and expand Kumashiro's analysis. Kumashiro concludes the conversation with additional reflections on barriers and contradictions involved in advancing anti-oppressive educational research in educational journals. (Contains 3 notes.)