Testing for anaplastic lymphoma kinase rearrangement to target crizotinib therapy: oncology, pathology and health economic perspectives.

Crizotinib is a first-in-class oral anaplastic lymphoma kinase (ALK) inhibitor targeting ALK-rearranged non-small-cell lung cancer. The therapy was approved by the US FDA in August 2011 and received conditional marketing approval by the European Commission in October 2012 for advanced non-small-cell lung cancer. A break-apart FISH-based assay was jointly approved with crizotinib by the FDA. This assay and an immunohistochemistry assay that uses a D5F3 rabbit monoclonal primary antibody were also approved for marketing in Europe in October 2012. While ALK rearrangement has relatively low prevalence, a clinical benefit is exhibited in more than 85% of patients with median progression-free survival of 8-10 months. In this article, the authors summarize the therapy and alternative test strategies for identifying patients who are likely to respond to therapy, including key issues for effective and efficient testing. The key economic considerations regarding the joint companion diagnostic and therapy are also presented. Given the observed clinical benefit and relatively high cost of crizotinib therapy, companion diagnostics should be evaluated relative to response to therapy versus correlation alone whenever possible, and both high inter-rater reliability and external quality assessment programs are warranted.

Working Together To Reduce The Harms Caused By Alcohol Misuse: Report of the Working Group on Alcohol Misuse

The overall aim of the National Alcohol Policy, launched in 1996, is to reduce the level of alcohol-related problems and to promote moderation for those who wish to drink. This report complements the work of the Strategic Task Force on Alcohol (STFA) which takes primarily a public health approach as outlined in paragraph 1.1 of the Second Report of the STFA which states that â?othis approach, endorsed by the WHO, recognises that alcohol contributes to a range of health, social and behavioural problems- in terms of its toxicity, its potential to create dependency and its negative impact on human behaviour. The overall level of alcohol consumption and the predominant pattern of drinking in the population, are predictive of alcohol problems in any given society. Therefore, alcohol policy must take into account the total drinking population when defining the scope of public health action as well targeting high risk groups and individual high risk drinkers.â?Âù Download the Report (PDF, 202kb)

Report of the National Working Group on the Regulation of Complementary Therapists to the Minister for Health and Children

The focus of this report is the regulation of complementary therapists and, as such, does not deal directly with the efficacy of such therapies. It is for the consumer to make the choice of which therapy they intend to use. Whether they wish to consult a qualified therapist such as a homeopath or an acupuncturist, a healer, the seventh son of a seventh son, a person reputed to have a cure for a particular ailment or a person with a special skill with bones; the choice is theirs. Read the report (PDF 607kb) Download the accompanying leaflet (PDF 300kb) Note – Re: Page 70. ASK Ireland wish to clarify that the Kinesiology Association of Ireland do not represent the Association of Systematic Kinesiology in Ireland, in any way.

A Vision for Change - Report of the Expert Group on Mental Health Policy

This Report proposes a framework of mental health service delivery with the service user at its centre. The emphasis is firmly on recovery and on facilitating active partnerships between service users, carers and mental health  professionals. Its recommendations are innovative and some of them are challenging. However, I have nodoubt that their implementation will bring about farreaching change and modernisation in the Irish mentalhealth services, which will be to the benefit of everyone concerned.” Tim O'Malley T.D.Minister of State at the Department of Health & Childrenwith special responsibility for mental health Download the Report (PDF, 1mb)

Identification of snails within the Bulinus africanus group from East Africa by multiplex SNaPshotTManalysis of single nucleotide polymorphisms within the cytochrome oxidase subunit I

Identification of populations of Bulinus nasutus and B. globosus from East Africa is unreliable using characters of the shell. In this paper, a molecular method of identification is presented for each species based on DNA sequence variation within the mitochondrial cytochrome oxidase subunit I (COI) as detected by a novel multiplexed SNaPshotTM assay. In total, snails from 7 localities from coastal Kenya were typed using this assay and variation within shell morphology was compared to reference material from Zanzibar. Four locations were found to contain B. nasutus and 2 locations were found to contain B. globosus. A mixed population containing both B. nasutus and B. globosus was found at Kinango. Morphometric variation between samples was considerable and UPGMA cluster analysis failed to differentiate species. The multiplex SNaPshotTM assay is an important development for more precise methods of identification of B. africanus group snails. The assay could be further broadened for identification of other snail intermediate host species.

Annual Output Statement 2007 For Health Group of Votes

Annual Output Statement 2007 For Health Group of Votes The overall aim of this Vote Group is to provide health and personal social services to improve the health and well being of the people of Ireland in a manner that promotes better health for everyone, fair access, responsive and appropriate care delivery and high performance. The money voted goes to the of Health and Children (Vote 39), the Health Service Executive (Vote 40), and the Office of the Minister for Children (Vote 41). Click here to download PDF 92kb

Annual Report of the Elder Abuse National Implementation Group, 2006

Annual Report of the Elder Abuse National Implementation Group, 2006 The specific function of the Elder Abuse National Implementation Group (EANIG) is to overview the implementation of Protecting Our Future (Department of Health and Children, 2002) by various government agencies and other bodies. Protecting our Future became official health policy in November 2002. The group met on four occasions during 2006. I would like to thank the following members who retired from the Group for their hard work and contribution to the elder abuse programme: Ms Mary McDermott, Cllr Eibhlin Byrne, Mr Shay Costello, Ms Anne-Marie Ross and Mr Tom Leonard. A full list of current members is provided at Appendix A. Click here to download PDF 157kb

First Annual Report of the Independent Monitoring Group on "A Vision for Change"

First Annual Report of the Independent Monitoring Group on “A Vision for Change” In January 2006, the Government adopted the Report of the Expert Group on Mental Health Policy "A Vision for Change"Âù as the basis for the future development of mental health services. In March 2006, the Minister of State at the Department of Health and Children, Mr Tim Oâ?TMalley, T.D., with special responsibility for mental health services, established the independent Monitoring Group to monitor progress on the implementation of the report recommendations. Click here to download PDF 255kb

Report of the Working Group on Rehabilitation (2007)

Report of the Working Group on Rehabilitation (2007) The Working Group on Drugs Rehabilitation arose from a recommendation in the Mid-Term Review of the National Drugs Strategy, which was published in June 2005. Extensive public consultations were conducted as part of the Mid-Term Review. Although it found that the current aims and objectives of the Drugs Strategy are fundamentally sound, the Review highlighted the need to re-focus priorities and accelerate the rollout of some of the Strategyâ?Ts actions and a number of new actions and amendments were included. Click here to download PDF

Report of the Implementation Group on Alcohol Misuse

Report of the Implementation Group on Alcohol Misuse The Implementation Group was formed to monitor and report on progress on the implementation of the recommendations contained in the report â?oWorking Together to Reduce the Harms Caused by Alcohol Misuseâ?T. This report was produced by a Working Group established under the Sustaining Progress Special Initiative on Alcohol and Drugs Misuse. The Working Group, which comprised Social Partners and relevant Government Departments and Agencies, Click here to download PDF: 84kb

Report of the Interdepartmental Working Group on Long Term Care, 2006

Report of the Interdepartmental Working Group on Long Term Care, 2006 This report was finalised by the working group at the end of 2005 and submitted to Government in January 2006. While the reportâ?Ts proposals were not formally endorsed by Government, its analysis and recommendations have informed subsequent decisions, including the Fair Deal policy on Long-Term Nursing Home Care.The principles underpinning the report formed the basis for discussions about long term care with the Social Partners prior to the new national programme negotiations leading to a clear vision articulated in Towards 2016 on a number of priority actions to support older people to participate in society in a full and meaningful way. Click here to download PDF 693kb

2nd Report of the Independent Monitoring Group on A Vision For Change

This is the Second Annual Report of the Independent Monitoring Group for A Vision for Change the Report of the Expert Group on Mental Health Policy. The Monitoring Group was established in March 2006 to monitor and assess progress on the implementation of A Vision for Change. In this Second Report, the Monitoring Group has found that by and large the recommendations in its first report were not addressed in 2007, although some have been prioritised for implementation in 2008. Download document here

Third Annual Report of the Independent Monitoring Group for A Vision for Change - the Report of the Expert Group on Mental Health Policy - April 2009

Third Annual Report of the Independent Monitoring Group for A Vision for Change – the Report of the Expert Group on Mental Health Policy – April 2009 Click here to download PDF 322kb

Response evaluation in third- and fourth-line treatment of GIST: the role of PET

Background: Response evaluation in gastrointestinal stromal tumors is difficult. Computed tomography and size-based assessments have been found inadequate to draw prognostic conclusions in patients treated with tyrosine kinase inhibitors (TKI). Density criteria (CHOI) have recently been shown to better define prognostic subsets of patients evaluated with CT. Still, positron emission tomography (PET) might be better at identifying responders with good outcome early, as shown for first and recently second-line treatment in GIST (Prior et al.; J Clin Oncol 2009). We wanted to evaluate the role of PET in third- and fourth-line TKI treatment of GIST. Methods: We retrospectively reviewed patients with GIST who had received third- or fourth-line treatment with TKI and had undergone PET for response evaluation. Patient needed to have a baseline and at least one subsequent PET. Results of the first "early" PET after treatment start have been used throughout this analysis and EORTC PET Study Group criteria applied. Results: Twelve treatment courses were evaluable, seven with Nilotinib in third- and five with Sorafenib in fourth-line treatment, in 8 patients, median age 60 y (range 36−78 y), who had all failed prior Imatinib and Sunitinib treatment due to disease progession. Baseline and follow-up PET were performed within a median of 34 days (range 9−84 days). Median progression-free survival (PFS) was 262 days in patients responding to PET versus 76 days in patients with stable or progressing disease (p = 0.15). Conclusions: This small series suggests that PET retains its value for outcome prediction in third- and fourth-line TKI treatment of GIST. This could be of particular clinical value in these vulnerable patients with large tumour masses. Early PET may help in stopping ineffective, but toxic therapy and help switching to a more effective therapy. PET should be evaluated further in this patient population.