Anti-Inflammatory and antiosteoclastogenic activities of parthenolide on human periodontal ligament cellsIn vitro

Periodontitis is an inflammatory disease that causes osteolysis and tooth loss. It is known that the nuclear factor kappa B (NF-κB) signalling pathway plays a key role in the progression of inflammation and osteoclastogenesis in periodontitis. Parthenolide (PTL), a sesquiterpene lactone extracted from the shoots of Tanacetum parthenium, has been shown to possess anti-inflammatory properties in various diseases. In the study reported herein, we investigated the effects of PTL on the inflammatory and osteoclastogenic response of human periodontal ligament-derived cells (hPDLCs) and revealed the signalling pathways in this process. Our results showed that PTL decreased NF-κB activation, I-κB degradation, and ERK activation in hPDLCs. PTL significantly reduced the expression of inflammatory (IL-1β, IL-6, and TNF-α) and osteoclastogenic (RANKL, OPG, and M-CSF) genes in LPS-stimulated hPDLCs. In addition, PTL attenuated hPDLC-induced osteoclastogenic differentiation of macrophages (RAW264.7 cells), as well as reducing gene expression of osteoclast-related markers in RAW264.7 cells in an hPDLC-macrophage coculture model. Taken together, these results demonstrate the anti-inflammatory and antiosteoclastogenic activities of PTL in hPDLCs in vitro. These data offer fundamental evidence supporting the potential use of PTL in periodontitis treatment.

The effectiveness of information-sharing interventions to reduce anxiety in families waiting for surgical patients undergoing an elective surgical procedure: A systematic review

Background Whilst waiting for patients undergoing surgery, a lack of information regarding the patient’s status and the outcome of surgery, can contribute to the anxiety experienced by family members. Effective strategies for providing information to families are therefore required. Objectives To synthesize the best available evidence in relation to the most effective information-sharing interventions to reduce anxiety for families waiting for patients undergoing an elective surgical procedure. Inclusion criteria Types of participants All studies of family members over 18 years of age waiting for patients undergoing an elective surgical procedure were included, including those waiting for both adult and pediatric patients.   Types of intervention All information-sharing interventions for families of patients undergoing an elective surgical procedure were eligible for inclusion in the review. Types of studies All randomized controlled trials (RCTs) quasi-experimental studies, case-controlled and descriptive studies, comparing one information-sharing intervention to another or to usual care were eligible for inclusion in the review. Types of outcomes Primary outcome: The level of anxiety amongst family members or close relatives whilst waiting for patients undergoing surgery, as measured by a validated instrument such as the S-Anxiety portion of the State-Trait Anxiety Inventory (STAI). Secondary outcomes: Family satisfaction and other measurements that may be considered indicators of stress and anxiety, such as mean arterial pressure (MAP) and heart rate. Search strategy A comprehensive search, restricted to English language only, was undertaken of the following databases from 1990 to May 2013: Medline, CINAHL, EMBASE, ProQuest, Web of Science, PsycINFO, Scopus, Dissertation and Theses PQDT (via ProQuest), Current Contents, CENTRAL, Google Scholar, OpenGrey, Clinical Trials, Science.gov, Current Controlled Trials and National Institute for Clinical Studies (NHMRC). Methodological quality Two independent reviewers critically appraised retrieved papers for methodological quality using the standardized critical appraisal instruments for randomized controlled trials and descriptive studies from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instruments (JBI-MAStARI). Data extraction Two independent reviewers extracted data from included papers using a customized data extraction form. Data synthesis Statistical pooling was not possible, mainly due to issues with data reporting in two of the studies, therefore the results are presented in narrative form. Results Three studies with a total of 357 participants were included in the review. In-person reporting to family members was found to be effective in comparison with usual care in which no reports were provided. Telephone reporting was also found to be effective at reducing anxiety, in comparison with usual care, although not as effective as in-person reporting. The use of paging devices to keep family members informed were found to increase, rather than decrease anxiety. Conclusions Due to the lack of high quality research in this area, the strength of the conclusions are limited. It appears that in-person and telephone reporting to family members decreases anxiety, however the use of paging devices increases anxiety.

Predicting Australian adults' sun-safe behaviour : examining the role of personal and social norms

Objectives To address the scarcity of comprehensive, theory-based research in the Australian context, this study, using a theory of planned behaviour (TPB) framework, investigated the role of personal and social norms to identify the key predictors of adult Australians' sun-safe intentions and behaviour. Design The study used a prospective design with two waves of data collection, 1 week apart. Methods Participants were 816 adults (48.2% men) aged between 18 and 88 years recruited from urban, regional, and rural areas of Australia. At baseline, participants completed a questionnaire assessing the standard TPB predictors (attitude, subjective norm, and perceived behavioural control [PBC]), past behaviour, behavioural intention, and additional measures of group norm for the referent groups of friends and family, image norm, personal norm, personal choice/responsibility, and Australian identity. Seventy-one per cent of the participants (n = 577) reported on their sun-safe behaviour in the subsequent week. Results Via path modelling, past behaviour, attitude, group norm (friends), personal norm, and personal choice/responsibility emerged as independent predictors of intentions which, in turn, predicted sun-safe behaviour prospectively. Past behaviour, but not PBC, had direct effects on sun-safe behaviour. The model explained 61.6% and 43.9% of the variance in intention and behaviour, respectively. Conclusions This study provides support for the use of a comprehensive theoretical decision-making model to explain Australian adults' sun-safe intentions and behaviours and identifies viable targets for health-promoting messages in this high-risk context.

Competitive interactions of anti-carcinogens with serum albumin: A spectroscopic study of bendamustine and dexamethasone with the aid of chemometrics

Interactions between the anti-carcinogens, bendamustine (BDM) and dexamethasone (DXM), with bovine serum albumin (BSA) were investigated with the use of fluorescence and UV–vis spectroscopies under pseudo-physiological conditions (Tris–HCl buffer, pH 7.4). The static mechanism was responsible for the fluorescence quenching during the interactions; the binding formation constant of the BSA–BDM complex and the binding number were 5.14 × 105 L mol−1 and 1.0, respectively. Spectroscopic studies for the formation of BDM–BSA complex were interpreted with the use of multivariate curve resolution – alternating least squares (MCR–ALS), which supported the complex formation. The BSA samples treated with site markers (warfarin – site I and ibuprofen – site II) were reacted separately with BDM and DXM; while both anti-carcinogens bound to site I, the binding constants suggested that DXM formed a more stable complex. Relative concentration profiles and the fluorescence spectra associated with BDM, DXM and BSA, were recovered simultaneously from the full fluorescence excitation–emission data with the use of the parallel factor analysis (PARAFAC) method. The results confirmed that on addition of DXM to the BDM–BSA complex, the BDM was replaced and the DXM–BSA complex formed; free BDM was released. This finding may have consequences for the transport of these drugs during any anti-cancer treatment.

Antisocial personality disorder and therapeutic justice court programs

It has become commonplace for courts to supervise an offender as part of the sentencing process. Many of them have Anti Social Personality Disorder (ASPD). The focus of this article is how the work of specialist and/or problem solving courts can be informed by the insights of the psychology profession into the best practice in the treatment and management of people with ASPD. It is a legitimate purpose of legal work to consider and improve the well-being of the participants in the legal process. Programs designed specifically to deal with those with ASPD could be incorporated into existing Drug Courts, or implemented separately by courts to aid with reforming offenders with ASPD and in managing the re-entry of offenders into the community as part of their sentence. For the success of this initiative on the part of the court, ASPD will need to be specifically diagnosed and treated. Close co-operation between courts and psychologists is required to improve the effectiveness of court programs to treat people with ASPD and to evaluate their success.

Developing a therapeutic anti-dendritic cell antibody to prevent graft versus host disease

Host and donor dendritic cells (DC) stimulate alloreactive donor T lymphocytes, and initiate GVHD. We have shown that polyclonal antibody to the DC surface activation marker human CD83 (anti hCD83), which depletes activated DC, can prevent human DC and T cell induced lethal xenogeneic GVHD in SCID mice without impairing T cell mediated anti-leukaemic and anti-viral (CMV and influenza) immunity (J Exp Med 2009; 206: 387). Therefore, we made and tested a polyclonal anti mouse CD83 (RAM83) antibody in murine HSCT models and developed a human mAb against hCD83 as a potential new therapeutic immunosuppressive agent.

Rejected! The harmful effects of workgroup mistreatment and the moderating role of organisational norms

This program of research investigated the harmful effects of mistreatment by the workgroup, and the role of perceived rejection as a critical mediator linking mistreatment and outcomes. This research program had three primary purposes. First, the research aimed to examine the important role of workgroup mistreatment as an independent predictor of negative outcomes, over and above the influence of supervisor mistreatment. Second, the research aimed to examine the effect of perceived rejection as an explanatory variable linking workgroup mistreatment and outcomes. Finally, the moderating effect of organizational norms on the relationship between workgroup mistreatment and perceived rejection was examined. The relationships of interest were examined over four studies, using multiple methods of data collection, across part-time and full-time working samples. In Study 1 (Chapter 2), the independent role of workgroup mistreatment and the mediating role of perceived rejection were examined. One hundred and forty two part-time working participants took part in the study. The participants completed a questionnaire on workplace behaviors in their organizations. The results of hierarchical regression analyses revealed a strong harmful effect of workgroup mistreatment, independent of mistreatment by the supervisor. In addition, the results showed that perceived rejection fully mediated the relationship between workgroup mistreatment and depression and organizational based self esteem. The study highlighted that perceived rejection acts as a key underlying psychological mechanism involved in the effect of workgroup mistreatment. This study has been published in the Journal of Occupational Health Psychology. Study 2 and Study 3 were presented as one paper in Chapter 3. The aims of these two studies was to explore the effects of workgroup mistreatment on a wider range of individual and organizational level outcomes, and to provide further evidence of the mediating role of perceived rejection as observed in Study 1. The results from both studies demonstrated that workgroup mistreatment had a significant and independent role in predicting negative individual and organizational level outcomes, providing support for the findings of Study 1. In the first study, 189 participants received scenarios manipulating workgroup mistreatment and supervisor mistreatment. The results of hierarchical regression analyses revealed that workgroup mistreatment harmfully affected participants, over and above that of the supervisor. The results also demonstrated that perceived rejection mediated the positive relationships between workgroup mistreatment and depression and organizational deviance, and also the negative relationships between workgroup mistreatment and organizational based self esteem and organizational citizenship behaviors. The second study included an additional aim, to examine the moderating role of supportive organizational norms. Two hundred and twenty nine participants read scenarios that manipulated workgroup mistreatment, supervisor mistreatment and organizational norms. The results of hierarchical regression analyses revealed the significant harmful effects of workgroup mistreatment, over and above the influence of supervisor mistreatment. The results also revealed the mediating role of perceived rejection. The direct effect of positive organizational norms also emerged, consistent with previous research. In addition, the result revealed that employees who experienced supportive organizational norms were more likely to reconcile with their workgroup members after experiencing mistreatment compared to employees who experienced hostile organizational norms. Finally, an unexpected pattern on the key affective variables of depression and organizational based self esteem emerged, such that mistreatment led to more negative outcomes in the supportive norms condition than in the hostile condition, where employees appeared to be desensitized. This paper is currently under review at the Journal of Applied Social Psychology. In Study 4 (Chapter 4), the overall model of workplace mistreatment was tested on a sample of full-time workers in an applied setting. One hundred and seventy two adults took part in the study. Participants were required to evaluate their workplace regarding mistreatment and organizational norms and to report their own psychological, behavioral and organizational outcomes. The results revealed that workgroup mistreatment was associated with increased depression, stress and avoidance, over and above supervisor mistreatment. In addition, the results revealed that perceived rejection acted as an explanatory variable linking workgroup mistreatment to a number of outcomes. Furthermore, the moderating role of hostile organizational norms emerged on depression, stress, reconciliation and avoidance. This paper is currently under review at the Journal of Occupational Health Psychology. Overall, the four studies provided empirical support for the majority of the hypotheses. The effects were demonstrated for a range of psychological, behavioral, and organizational level outcomes, using multiple methods of data collection, across part-time and full-time workers. At the conclusion of the thesis (Chapter 5), an overall summary is provided of the findings across all four studies, practical and theoretical implications and research directions.

Feeling left out? The mediating role of perceived rejection on workgroup mistreatment and affective, behavioral, and organizational outcomes and the moderating role of organizational norms

This two-study paper examines the detrimental impact of workgroup mistreatment and the mediating role of perceived rejection. In Study 1, perceived rejection emerged as a mediator between workgroup mistreatment and depression, organization-based self-esteem, organizational deviance, and organizational citizenship behaviors. In Study 2, the role of organizational norms was examined. Employees who experienced supportive organizational norms reported lower levels of perceived rejection, depression and turnover intentions, and higher levels of organization-based self-esteem and job satisfaction. Employees in the supportive norms condition reported that they were more likely to seek reconciliation after experiencing mistreatment than those who experienced low support. Perceived rejection also emerged as a mediator. Results, practical implications, and future research directions are discussed.

Safety of OPRA procedure for individuals with upper limb amputation

Surgical implantations of osseointegrated fixations for bone-anchored prosthesis are developing at an unprecedented pace worldwide while initial skepticism in the orthopedic community is slowly fading away. Clearly, this option is becoming accessible to a wide range of individuals with limb loss. [1-18] The team led by Dr Rickard Branemark has previously published a number of landmark articles focusing on the benefits and safety of the OPRA fixation mainly for individual with lower limb loss, particularly those with transfemoral amputation. [1-3, 19-32] However, similar information is lacking for those with upper limb amputation. This team is once again taking a leading role by sharing a retrospective study focusing on the implant survival, adverse events, implant stability, and bone remodelling for 18 individuals with transhumeral amputation over a 5-year post-operative period. Therefore, a comprehensive analysis of the safety of the procedure is accessible for the first time. In essence, the results showed an implant survival rate of 83% and 80% at 2 and 5 year follow ups, respectively. The most frequent adverse events were superficial skin infections that occurred for 28% (5) participants while the least frequent was deep bone infection that happened only once. More importantly, 38% of complications due to infections were effectively managed with nonoperative treatments (e.g., revision of skin penetration site, local cleaning, antibiotics, restriction of soft tissue mobility). Implant stability and bone remodelling were satisfactory. Clearly, this study provided better understanding of the safety of the OPRA surgical and rehabilitation procedure for individuals with upper limb amputation while establishing standards and benchmark data for future studies. However, strong evidences of the benefits are yet to be demonstrated. However, increase in health related quality of life and functional outcomes (e.g., range of movement) are likely. Altogether, the team of authors are providing further evidence that bone-anchored attachment is definitely a promising alternative to socket prostheses.

The Complex Politics of Care: Needs and interests, norms and desires

If you want to understand something about a society, and the social contracts that underpin it, then understanding the way it positions women, children, those with corporeal or cognitive differences and other not-quitecitizens is a good place to start. As most now understand, this positioning is not natural; it is part of the high-stakes social, institutional and above all ideological labour of defining the human body, directing human behaviour and determining who will hold agency, authority and power...

Where to after Drink Rite: An evaluation of opportunities for police and community promotion of an anti-drink driving message in the licensed venue setting. Report to the National Drug Strategy Law Enforcement Funding Committee

Estimating the prevalence of drink driving is a difficult task. Self‐reported drink driving indicates that drink driving is far more common than official statistics suggest. In order to promote a responsible attitude towards alcohol consumption and drink driving within the Queensland community, the Queensland Police Service, Queensland Health and Queensland Transport developed the ‘Drink Rite’ program (Queensland Police Service information sheet, 2009). However, the feasibility of the program is now in doubt as the National Health and Medical Research Council’s guidelines for alcohol consumption changed in 2009 to state “For healthy men and women, drinking no more than four standard drinks on a single occasion reduces the risk of alcohol‐related injury arising from that occasion” (NHMRC Publication, 2009, p. 51). As such, adhering to the NHMRC guidelines places restrictions on how the existing Drink Rite program can be operated (i.e. by reducing the number of standard drinks provided to participants from eight to four). It is arguable that a reduction in the number of alcoholic drinks provided to participants in the program will result in a large reduction in observed BAC readings. This, in turn, will lead to a potential loss of message content when discussing the variation in the effects of alcohol.

Paralog-specific kinase inhibition of FGFR4: Adding to the arsenal of anti-FGFR agents

In this issue of Cancer Discovery, Hagel and colleagues report the design and the in vitro and in vivo activity of a novel, irreversible, paralog-specific kinase inhibitor of FGFR4, BLU9931. This compound binds covalently to a cysteine residue in the hinge region of FGFR4 but not in FGFR1-3. BLU9931 induces tumor shrinkage in hepatocellular carcinoma models that express a functioning ligand/receptor complex consisting of FGF19/FGFR4/KLB and adds to a growing list of anti-FGFR4 agents.

Anti-tumour effects of antibodies targeting the extracellular cysteine-rich region of the receptor tyrosine kinase EphB4

EphB4 is a membrane-bound receptor tyrosine kinase (RTK) commonly over-produced by many epithelial cancers but with low to no expression in most normal adult tissues. EphB4 over-production promotes ligand-independent signaling pathways that increase cancer cell viability and stimulate migration and invasion. Several studies have shown that normal ligand-dependent signaling is tumour suppressive and therefore novel therapeutics which block the tumour promoting ligand-independent signaling and/or stimulate tumour suppressive ligand-dependent signaling will find application in the treatment of cancer. An EphB4-specific polyclonal antibody, targeting a region of 200 amino acids in the extracellular portion of EphB4, showed potent in vitro anti-cancer effects measured by an increase in apoptosis and a decrease in anchorage independent growth. Peptide exclusion was used to identify the epitope targeted by this antibody within the cysteine-rich region of the EphB4 protein, a sequence defined as a potential ligand interacting interface. Addition of antibody to cancer cells resulted in phosphorylation and subsequent degradation of the EphB4 protein, suggesting a mechanism that is ligand mimetic and tumour suppressive. A monoclonal antibody which specifically targets this identified extracellular epitope of EphB4 significantly reduced breast cancer xenograft growth in vivo confirming that EphB4 is a useful target for ligand-mimicking antibody-based anti-cancer therapies.

Trick or treaty?: The Australian debate over the Anti-Counterfeiting Trade Agreement

The secretive 2011 Anti-Counterfeiting Trade Agreement – known in short by the catchy acronym ACTA – is a controversial trade pact designed to provide for stronger enforcement of intellectual property rights. The preamble to the treaty reads like pulp fiction – it raises moral panics about piracy, counterfeiting, organised crime, and border security. The agreement contains provisions on civil remedies and criminal offences; copyright law and trademark law; the regulation of the digital environment; and border measures. Memorably, Susan Sell called the international treaty a TRIPS Double-Plus Agreement, because its obligations far exceed those of the World Trade Organization's TRIPS Agreement 1994, and TRIPS-Plus Agreements, such as the Australia-United States Free Trade Agreement 2004. ACTA lacks the language of other international intellectual property agreements, which emphasise the need to balance the protection of intellectual property owners with the wider public interest in access to medicines, human development, and transfer of knowledge and technology. In Australia, there was much controversy both about the form and the substance of ACTA. While the Department of Foreign Affairs and Trade was a partisan supporter of the agreement, a wide range of stakeholders were openly critical. After holding hearings and taking note of the position of the European Parliament and the controversy in the United States, the Joint Standing Committee on Treaties in the Australian Parliament recommended the deferral of ratification of ACTA. This was striking as representatives of all the main parties agreed on the recommendation. The committee was concerned about the lack of transparency, due process, public participation, and substantive analysis of the treaty. There were also reservations about the ambiguity of the treaty text, and its potential implications for the digital economy, innovation and competition, plain packaging of tobacco products, and access to essential medicines. The treaty has provoked much soul-searching as to whether the Trick or Treaty reforms on the international treaty-making process in Australia have been compromised or undermined. Although ACTA stalled in the Australian Parliament, the debate over it is yet to conclude. There have been concerns in Australia and elsewhere that ACTA will be revived as a ‘zombie agreement’. Indeed, in March 2013, the Canadian government introduced a bill to ensure compliance with ACTA. Will it be also resurrected in Australia? Has it already been revived? There are three possibilities. First, the Australian government passed enhanced remedies with respect to piracy, counterfeiting and border measures in a separate piece of legislation – the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth). Second, the Department of Foreign Affairs and Trade remains supportive of ACTA. It is possible, after further analysis, that the next Australian Parliament – to be elected in September 2013 – will ratify the treaty. Third, Australia is involved in the Trans-Pacific Partnership negotiations. The government has argued that ACTA should be a template for the Intellectual Property Chapter in the Trans-Pacific Partnership. The United States Trade Representative would prefer a regime even stronger than ACTA. This chapter provides a portrait of the Australian debate over ACTA. It is the account of an interested participant in the policy proceedings. This chapter will first consider the deliberations and recommendations of the Joint Standing Committee on Treaties on ACTA. Second, there was a concern that ACTA had failed to provide appropriate safeguards with respect to civil liberties, human rights, consumer protection and privacy laws. Third, there was a concern about the lack of balance in the treaty’s copyright measures; the definition of piracy is overbroad; the suite of civil remedies, criminal offences and border measures is excessive; and there is a lack of suitable protection for copyright exceptions, limitations and remedies. Fourth, there was a worry that the provisions on trademark law, intermediary liability and counterfeiting could have an adverse impact upon consumer interests, competition policy and innovation in the digital economy. Fifth, there was significant debate about the impact of ACTA on pharmaceutical drugs, access to essential medicines and health-care. Sixth, there was concern over the lobbying by tobacco industries for ACTA – particularly given Australia’s leadership on tobacco control and the plain packaging of tobacco products. Seventh, there were concerns about the operation of border measures in ACTA. Eighth, the Joint Standing Committee on Treaties was concerned about the jurisdiction of the ACTA Committee, and the treaty’s protean nature. Finally, the chapter raises fundamental issues about the relationship between the executive and the Australian Parliament with respect to treaty-making. There is a need to reconsider the efficacy of the Trick or Treaty reforms passed by the Australian Parliament in the 1990s.

A Submission to the Joint Standing Committee on Treaties on the Anti-Counterfeiting Trade Agreement 2011 (# ACTA)

“If Hollywood could order intellectual property laws for Christmas, what would they look like? This is pretty close.” David Fewer “While European and American IP maximalists have pushed for TRIPS-Plus provisions in FTAs and bilateral agreements, they are now pushing for TRIPS-Plus-Plus protections in these various forums.” Susan Sell “ACTA is a threat to the future of a free and open Internet.” Alexander Furnas “Implementing the agreement could open a Pandora's box of potential human rights violations.” Amnesty International. “I will not take part in this masquerade.” Kader Arif, Rapporteur for the Anti-Counterfeiting Trade Agreement 2011 in the European Parliament Executive Summary As an independent scholar and expert in intellectual property, I am of the view that the Australian Parliament should reject the adoption of the Anti-Counterfeiting Trade Agreement 2011. I would take issue with the Department of Foreign Affairs and Trade’s rather partisan account of the negotiations, the consultations, and the outcomes associated with the Anti-Counterfeiting Trade Agreement 2011. In my view, the negotiations were secretive and biased; the local consultations were sometimes farcical because of the lack of information about the draft texts of the agreement; and the final text of the Anti-Counterfeiting Trade Agreement 2011 is not in the best interests of Australia, particularly given that it is a net importer of copyright works and trade mark goods and services. I would also express grave reservations about the quality of the rather pitiful National Interest Analysis – and the lack of any regulatory impact statement – associated with the Anti-Counterfeiting Trade Agreement 2011. The assertion that the Anti-Counterfeiting Trade Agreement 2011 does not require legislative measures is questionable – especially given the United States Trade Representative has called the agreement ‘the highest-standard plurilateral agreement ever achieved concerning the enforcement of intellectual property rights.’ It is worthwhile reiterating that there has been much criticism of the secretive and partisan nature of the negotiations surrounding the Anti-Counterfeiting Trade Agreement 2011. Sean Flynn summarizes these concerns: "The negotiation process for ACTA has been a case study in establishing the conditions for effective industry capture of a lawmaking process. Instead of using the relatively transparent and inclusive multilateral processes, ACTA was launched through a closed and secretive “‘club approach’ in which like-minded jurisdictions define enforcement ‘membership’ rules and then invite other countries to join, presumably via other trade agreements.” The most influential developing countries, including Brazil, India, China and Russia, were excluded. Likewise, a series of manoeuvres ensured that public knowledge about the specifics of the agreement and opportunities for input into the process were severely limited. Negotiations were held with mere hours notice to the public as to when and where they would be convened, often in countries half away around the world from where public interest groups are housed. Once there, all negotiation processes were closed to the public. Draft texts were not released before or after most negotiating rounds, and meetings with stakeholders took place only behind closed doors and off the record. A public release of draft text, in April 2010, was followed by no public or on-the-record meetings with negotiators." Moreover, it is disturbing that the Anti-Counterfeiting Trade Agreement 2011 has been driven by ideology and faith, rather than by any evidence-based policy making Professor Duncan Matthews has raised significant questions about the quality of empirical evidence used to support the proposal of Anti-Counterfeiting Trade Agreement 2011: ‘There are concerns that statements about levels of counterfeiting and piracy are based either on customs seizures, with the actual quantities of infringing goods in free circulation in any particular market largely unknown, or on estimated losses derived from industry surveys.’ It is particularly disturbing that, in spite of past criticism, the Department of Foreign Affairs and Trade has supported the Anti-Counterfeiting Trade Agreement 2011, without engaging the Productivity Commission or the Treasury to do a proper economic analysis of the proposed treaty. Kader Arif, Rapporteur for the Anti-Counterfeiting Trade Agreement 2011 in the European Parliament, quit his position, and said of the process: "I want to denounce in the strongest possible manner the entire process that led to the signature of this agreement: no inclusion of civil society organisations, a lack of transparency from the start of the negotiations, repeated postponing of the signature of the text without an explanation being ever given, exclusion of the EU Parliament's demands that were expressed on several occasions in our assembly. As rapporteur of this text, I have faced never-before-seen manoeuvres from the right wing of this Parliament to impose a rushed calendar before public opinion could be alerted, thus depriving the Parliament of its right to expression and of the tools at its disposal to convey citizens' legitimate demands.” Everyone knows the ACTA agreement is problematic, whether it is its impact on civil liberties, the way it makes Internet access providers liable, its consequences on generic drugs manufacturing, or how little protection it gives to our geographical indications. This agreement might have major consequences on citizens' lives, and still, everything is being done to prevent the European Parliament from having its say in this matter. That is why today, as I release this report for which I was in charge, I want to send a strong signal and alert the public opinion about this unacceptable situation. I will not take part in this masquerade." There have been parallel concerns about the process and substance of the Anti-Counterfeiting Trade Agreement 2011 in the context of Australia. I have a number of concerns about the substance of the Anti-Counterfeiting Trade Agreement 2011. First, I am concerned that the Anti-Counterfeiting Trade Agreement 2011 fails to provide appropriate safeguards in respect of human rights, consumer protection, competition, and privacy laws. It is recommended that the new Joint Parliamentary Committee on Human Rights investigate this treaty. Second, I argue that there is a lack of balance to the copyright measures in the Anti-Counterfeiting Trade Agreement 2011 – the definition of piracy is overbroad; the suite of civil remedies, criminal offences, and border measures is excessive; and there is a lack of suitable protection for copyright exceptions, limitations, and remedies. Third, I discuss trade mark law, intermediary liability, and counterfeiting. I express my concerns, in this context, that the Anti-Counterfeiting Trade Agreement 2011 could have an adverse impact upon consumer interests, competition policy, and innovation in the digital economy. I also note, with concern, the lobbying by tobacco industries for the Anti-Counterfeiting Trade Agreement 2011 – and the lack of any recognition in the treaty for the capacity of countries to take measures of tobacco control under the World Health Organization Framework Convention on Tobacco Control. Fourth, I note that the Anti-Counterfeiting Trade Agreement 2011 provides no positive obligations to promote access to essential medicines. It is particularly lamentable that Australia and the United States of America have failed to implement the Doha Declaration on the TRIPS Agreement and Public Health 2001 and the WTO General Council Decision 2003. Fifth, I express concerns about the border measures in the Anti-Counterfeiting Trade Agreement 2011. Such measures lack balance – and unduly favour the interests of intellectual property owners over consumers, importers, and exporters. Moreover, such measures will be costly, as they involve shifting the burden of intellectual property enforcement to customs and border authorities. Interdicting, seizing, and destroying goods may also raise significant trade issues. Finally, I express concern that the Anti-Counterfeiting Trade Agreement 2011 undermines the role of existing international organisations, such as the United Nations, the World Intellectual Property Organization and the World Trade Organization, and subverts international initiatives such as the WIPO Development Agenda 2007. I also question the raison d'être, independence, transparency, and accountability of the proposed new ‘ACTA Committee’. In this context, I am concerned by the shift in the position of the Labor Party in its approach to international treaty-making in relation to intellectual property. The Australian Parliament adopted the Australia-United States Free Trade Agreement 2004, which included a large Chapter on intellectual property. The treaty was a ‘TRIPs-Plus’ agreement, because the obligations were much more extensive and prescriptive than those required under the multilateral framework established by the TRIPS Agreement 1994. During the debate over the Australia-United States Free Trade Agreement 2004, the Labor Party expressed the view that it would seek to mitigate the effects of the TRIPS-Plus Agreement, when at such time it gained power. Far from seeking to ameliorate the effects of the Australia-United States Free Trade Agreement 2004, the Labor Government would seek to lock Australia into a TRIPS-Double Plus Agreement – the Anti-Counterfeiting Trade Agreement 2011. There has not been a clear political explanation for this change in approach to international intellectual property. For both reasons of process and substance, I conclude that the Australian Parliament and the Australian Government should reject the Anti-Counterfeiting Trade Agreement 2011. The Australian Government would do better to endorse the Washington Declaration on Intellectual Property and the Public Interest 2011, and implement its outstanding obligations in respect of access to knowledge, access to essential medicines, and the WIPO Development Agenda 2007. The case study of the Anti-Counterfeiting Trade Agreement 2011 highlights the need for further reforms to the process by which Australia engages in international treaty-making.