Interim Measure Research Articles

Neuraminidase-Inhibiting Antibody Is a Correlate of Cross-Protection against Lethal H5N1 Influenza Virus in Ferrets Immunized with Seasonal Influenza Vaccine

In preparing for the threat of a pandemic of avian H5N1 influenza virus, we need to consider the significant delay (4 to 6 months) necessary to produce a strain-matched vaccine. As some degree of cross-reactivity between seasonal influenza vaccines and H5N1 virus has been reported, this was further explored in the ferret model to determine the targets of protective immunity. Ferrets were vaccinated with two intramuscular inoculations of trivalent inactivated split influenza vaccine or subcomponent vaccines, with and without adjuvant, and later challenged with a lethal dose of A/Vietnam/1203/2004 (H5N1) influenza virus. We confirmed that vaccination with seasonal influenza vaccine afforded partial protection against lethal H5N1 challenge and showed that use of either AlPO(4) or Iscomatrix adjuvant with the vaccine resulted in complete protection against disease and death. The protection was due exclusively to the H1N1 vaccine component, and although the hemagglutinin contributed to protection, the dominant protective response was targeted toward the neuraminidase (NA) and correlated with sialic acid cleavage-inhibiting antibody titers. Purified heterologous NA formulated with Iscomatrix adjuvant was also protective. These results suggest that adjuvanted seasonal trivalent vaccine could be used as an interim measure to decrease morbidity and mortality from H5N1 prior to the availability of a specific vaccine. The data also highlight that an inducer of cross-protective immunity is the NA, a protein whose levels are not normally monitored in vaccines and whose capacity to induce immunity in recipients is not normally assessed.

Novel Remedies for Intellectual Property Rights Infringement Online

The paper explores the failure of traditional civil remedies, as well as newer “three strikes” and Internet filtering remedies, to tackle intellectual property rights infringement on the Internet. Although the “three strikes” and Internet filtering/blocking measures were introduced in response to inadequacy of traditional remedies, over the decade of practical applications they have not achieved significant success, as well. Principal socio-legal reasons for such failures are reviewed and analyzed. Main reasons are found to be that traditional remedies and first generation new remedies are tailored to “offline” environment. Existing remedies are more suited to traditional legal interactions, where the parties are clearly identifiable and jurisdictional collisions are well defined. The way of action of existing remedies is inherently offline. They are ill adapted to the requirements of the online environment, such as difficulty to identify anonymous parties in multiplejurisdictions, and hence, high enforcement costs, as well as legal and technological complexity. It should be noted that online environment requires swift enforcement in view of the dynamic technological change. Based on this analysis, key features of the efficient online remedy design are identified. In the second part of the paper, a case study of successful enforcement of trademark rights online is presented. Example of rare success in enforcing legal liability for infringement of intellectual property rights is the special remedy of domain name seizure and takeover, implemented through the alternative and online dispute resolution procedure – the Uniform Domain Name Dispute Resolution Policy (UDRP). Domain seizure/takeover remedy implemented through the existing UDRP system works at the supranational level and successfully operates as an online instrument dealing with trademark rights infringement in the domain names. The author considers expansion of this special remedy and the domain seizure through the UDRP to cover copyright and related rights infringement as a viable addition to the existing remedies for the rights holders to deal with the online infringements. The former (that is a special sanction of domain seizure and take-over) may be relatively easily adopted by the judiciary both as an interim measure and as a final remedy; however, this would address only part of the challenges that enforcement of intellectual property rights faces online. Only the combination of the special sanctions and the online dispute resolution mechanism, capable to enforce such sanctions, address most inadequacies of traditional offline remedies (especially high cost, slowness and complexity, competence of the dispute resolution authority, as well as risks of political and legal abuses). This may be achieved through expansion of the existing UDRP system; however, it may need an additional supranational legal framework. The paper recognizes limitations of any rights enforcement instruments online, which are predefined by the nature of the online environment – its extraterritorial nature and span over jurisdictions, which may willingly tolerate infringement of intellectual property rights. These limitations would set the limits over the effectiveness of the novel remedies. Nevertheless, the domain seizure and take-over sanction made available for other infringements of the intellectual property rights online (chiefly copyright and related rights infringement) and enforced through relatively easily expandable UDRP system would complement the existing offline remedies and would expand the enforcement instrumentary for the rights holders, thus, enabling marginalization of the most popular intellectual property rights infringements online.

Authorship and Contributorship in Scholarly Journals

Authorship and Contributorship in Scholarly Journals

Ausgewählte Probleme der Zuständigkeit, Litispendenz und Anerkennung unter besonderer Berücksichtigung von Handelssachen

This article focuses on problems of jurisdiction, lis pendens and recognition of provisional measures in the scope of the application of Brussels I, particularly with regard to questions that are also relevant for commercial matters. The article comes to the following conclusion: The rules for jurisdiction for the substance of the matter are not transferable to jurisdiction for provisional measures, because in this respect other weighing of interests applies. Those interests that are aimed at effective enforcement of the law gain considerable importance because interim legal protection bases on the idea of speedy and efficient legal protection. This applies to considerations on the restriction of forum shopping and of pending proceedings. As regards the latter the authors point out that it will not amount to an excessive increase of legal protection because of the risk that a successful interim measure is not recognised because a former negative decision of another member state bars the later interim measure.

Amino acid scoring patterns for protein quality assessment

The 1985 FAO/WHO/UNU protein report defined reference amino acid patterns for infants based on breast milk and for preschool children, schoolchildren and adults from age specific estimates of dietary indispensible amino acid requirements divided by the safe protein requirement for each age group. This report argued that the protein quality of a diet should be estimated from its digestibility adjusted by its amino acid score calculated from its limiting amino acid in comparison with the reference amino acid pattern. Subsequently a joint FAO/WHO expert consultation on protein quality evaluation (1991) endorsed this protein digestibility-corrected score approach. However it rejected the adult scoring pattern identified in the 1985 report arguing that the amino acid values for this pattern were too low. As an interim measure it suggested that the scoring pattern for preschool children should be used for all age groups apart from infants. The recent WHO/FAO/UNU (2007) report endorsed the 1985 report in recommending the amino acid content of breast milk as the best estimate of infant amino acid requirements. However it was only able to identify reliable requirement values for adults and adopted a factorial approach to derivation of age-related scoring patterns. This utilized the adult pattern for maintenance, and the pattern of human tissue protein for growth. Thus scoring patterns were derived for children aged 0·5, 1-2, 3-10, 11-14, 15-18 years and for adults. The total dietary amino acid requirements calculated for these age groups were divided by the mean protein requirement to give the scoring pattern which should be used to adjust digestible intakes to identify the available protein in specific diets. However because the adult values were determined in subjects at protein intakes much higher than the mean minimum protein requirement, i.e. at 1 g/kg/d rather than 0·66 g/kg/d, the pattern is likely to include higher values than the minimum requirement and should therefore be referenced against the safe allowance.

Interim reconstruction and space maintenance of mandibular continuity defects preceding definitive osseous reconstruction

The use of space maintenance in mandibular defects as an interim measure before definitive osseous reconstruction may prevent problems associated with delayed reconstruction including increased technical difficulty, contracture of soft tissues that limits the volume of the final reconstruction, and the potential for iatrogenic injury to adjacent anatomical structures. The use of a condyle/ramus spacer made of medical grade, ultrahigh-molecular-weight polyethylene, and a flexible body spacer made of high quality, inert, non-toxic medical and food grade silicone rubber, was tested in 38 patients with mandibular defects after the resection of benign but locally aggressive disease, advanced osteomyelitis, and injuries. The spacer was retained for a maximum of 8 weeks, and was then removed through an extraoral approach before definitive reconstruction with a particulate corticocancellous bone graft. One of the 38 patients failed to attend for follow up and returned 7 months later with severe, generalised sepsis that required removal of the spacer and exclusion from the study. Of the remaining 37 patients, 32 healed uneventfully, 1 required removal of the spacer 2 weeks after implantation for intraoral wound dehiscence, and 4 had mild to moderate disturbances of wound healing that required either minor revision or local wound care until removal at the time of reconstruction. The use of a spacer promotes wound healing and simplifies and expedites secondary reconstruction of mandibular defects.

The CLEAN project in the context of CO2 storage and enhanced gas recovery

R&D project CLEAN in the context of CO 2 storage and enhanced gas recovery Michael Kuhn 1,* , Uwe-Jens Gorke 2 , Jens T Birkholzer 3 , Olaf Kolditz 2,4 Helmholtz Centre Potsdam, GFZ - German Research Centre for Geosciences, Telegrafenberg, 14473 Potsdam, Germany Helmholtz Centre for Environmental Research, Permoserstrase 15, 04318 Leipzig, Germany Lawrence Berkeley National Laboratory, Earth Sciences Division, One Cyclotron Road, Berkeley, CA 94720, USA TU Dresden, Helmholtzstrase 10, 01062 Dresden, Germany *corresponding author Email: michael.kuehn@gfz-potsdam.de Phone +49 331 288 1594 Fax +49 331 288 1502 Anthropogenic emissions of carbon dioxide (CO 2 ) into the atmosphere have a significant impact on the Earth's carbon cycle. While efforts are made to reduce the release of greenhouse gases via reduced energy consumption, more efficient energy production, and a shift to renewable energy supplies, it is generally expected that fossil fuels will continue to provide a major part of the world’s energy portfolio during the 21 st century (IPCC 2005). This is particularly true for coal which is relatively inexpensive and abundantly available in existing or emerging industrial power houses such as the United States, Brazil, Russia, India, and China. Carbon Capture and Storage (CCS) has been developed as an interim measure to allow energy production from coal without CO 2 emissions. This currently available technology entails capturing CO 2 from large-scale industrial sources such as coal-fired power plants or cement, steel and petrochemical factories. The captured CO 2 gas is then compressed to a smaller volume, hence higher density, transported in pipelines, and eventually injected for long-term storage into deep geologic formations, such as deep saltwater-bearing aquifers or depleted oil and gas fields (IPCC 2005). Extensive research is currently carried out to (1) improve the technology and efficiency of capturing CO 2 and (2) to ensure the long-term safety of storing CO 2 underground. This volume of “Environmental Earth Sciences” is a Thematic Issue (TI) focusing on the geologic storage aspect of CCS. The idea of a TI as a new type of publication within this series is to assemble manuscripts dealing with a specific topic comprising its state-of-the art, providing recent research results, and discussing future work from an international perspective. This TI is dedicated to the recent progress made in Germany’s CO 2 storage R&D programme GEOTECHNOLOGIEN funded by the Federal Ministry of Education and Research (BMBF) and the German Research Foundation (DFG)

Trust management as an interim measure in litigation: an option in the Russian court practice?

Trust management as an interim measure in litigation: an option in the Russian court practice?

Peacekeeping in Lebanon and Civilian Protection

A major challenge to contemporary peace operations is the need to protect civilians. UNIFIL has been criticized for being ineffective and risk averse. The original mandate made no reference to civilian protection, but the protection of Lebanese civilians became an issue of concern when their treatment by Israeli forces in the aftermath of the 1982 Israeli invasion was brought to the attention of the Security Council. Since the invasion had transformed the situation on the ground, safeguarding the civilian population provided an interim solution to the disregard of United Nations Peacekeeping Force in Lebanon (UNIFIL's) authority by Israel. While the performance of humanitarian tasks as an interim measure was a worthwhile attempt to ease the plight of the local population, the loss of face and inability to prevent Israeli incursions damaged both the credibility and morale of UNIFIL. In the summer of 2006, the conflict between Hizbollah and Israel ‘radically changed’ the context in which UNIFIL operated. Resolution 1701 authorized a reconfigured UNIFIL to take all necessary action to protect civilians under imminent threat of physical violence. The creation of a Strategic Military Cell facilitated European engagement and rapid deployment. Nonetheless, it had definite drawbacks. While UNIFIL has successfully maintained a fragile peace, important aspects of the mandate remain unfulfilled. The primary responsibility for the protection of civilians remains the Lebanese Government. The 2006 conflict demonstrated that it is not possible to provide effective protection in the context of armed hostilities between Israel and Hizbollah. Today, UNIFIL seems dependent on the Government and maintaining good relations with armed elements for its security. Such a situation is inconsistent with it performing an effective protection role.

Non-invasive prenatal diagnosis for fetal sex determination: benefits and disadvantages from the service users' perspective.

Prenatal fetal sex determination is clinically indicated for women who are at risk of having a child with a serious genetic disorder affecting a particular sex. Ultrasound has been the traditional method used, but early fetal sex determination using non-invasive prenatal diagnosis (NIPD) can now be performed using cell-free fetal DNA in maternal plasma. The study aim was to assess the views and experiences of service users who had used NIPD for fetal sex determination. In this paper, we report on the perceived benefits and disadvantages. A qualitative approach using semi-structured interviews was used. A total of 44 participants (38 women and 6 partners of participating women) were recruited. Participants' views and experiences of NIPD were overwhelmingly positive. Concerning benefits over traditional methods, three themes emerged: (1) technical aspects of technology; (2) timing; and (3) enhanced decision-making. Practical advantages of NIPD included avoiding miscarriage, and there were a number of psychological advantages associated with timing such as perceived control, early re-engagement, normalization of pregnancy and peace of mind. Participants also valued NIPD as it enabled a stepwise approach to decision-making. A number of disadvantages were discussed including concerns about social sexing and increased bonding at a time in pregnancy when miscarriage risk is high. However, participants felt these were fairly minor in comparison with the advantages of NIPD. Until definitive genetic diagnosis using NIPD is available, NIPD for fetal sex determination is perceived as a good interim measure with a number of notable advantages over traditional methods.

Carnitine supplementation for inborn errors of metabolism.

Inborn errors of metabolism are genetic conditions which can lead to abnormalities in the synthesis and metabolism of proteins, carbohydrates, or fats. It has been proposed that in some instances carnitine supplementation should be provided to infants with a suspected metabolic disease as an interim measure, particularly whilst awaiting test results. Carnitine supplementation is used in the treatment of primary carnitine deficiency, and also where the deficiency is a secondary complication of several inborn errors of metabolism, such as organic acidaemias and fatty acid oxidation defects in children and adults. To assess the effectiveness and safety of carnitine supplementation in the treatment of inborn errors of metabolism. We searched the Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register, the Cochrane Central Register of Controlled Trials (The Cochrane Library 2007, Issue 4) and MEDLINE via Ovid (1950 to July week 4 2007), LILACS (15/05/2008) and Iranmedex (15/05/2008) and also the reference lists of retrieved articles.Date of most recent search of the Group's Inborn Errors of Metabolism Register: 27 October 2011. Randomised controlled trials and quasi-randomised controlled trials comparing carnitine supplementation (in different dose, frequency, or duration) versus placebo in children and adults diagnosed with an inborn error of metabolism. Two authors independently screened and assessed the eligibility of the identified trials. No trials were included in the review. There are no published or ongoing randomised controlled clinical trials relevant to this review question. Therefore, in the absence of any high level evidence, clinicians should base their decisions on clinical experience and in conjunction with preferences of the individual where appropriate. This does not mean that carnitine is ineffective or should not be used in any inborn error of metabolism. However, given the lack of evidence both on the effectiveness and safety of carnitine and on the necessary dose and frequency to be prescribed, the current prescribing practice should continue to be observed and monitored with care until further evidence is available. Methodologically sound trials, reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement, are required. It should be considered whether placebo-controlled trials in potentially lethal diseases, e.g. carnitine transporter disorder or glutaric aciduria type I, are ethical.

Avanços e percalços na elaboração da legislação nacional sobre acesso a recursos genéticos e aos conhecimentos tradicionais associados

O marco legal que regulamenta o acesso ao patrimônio genético, aos conhecimentos tradicionais associados, à tecnologia, à transferência de tecnologia para sua utilização e conservação e a repartição de benefícios no Brasil é uma Medida Provisória. Medidas Provisórias, em nosso ordenamento jurídico, são atos normativos com força de lei, que podem ser adotados pelo Presidente da República em casos de relevância e urgência. O caráter provisório da legislação que regula o tema perdura há dez anos, ainda sem data prevista para a edição da lei que a substitua. Em 2003, a Câmara Técnica Legislativa do Conselho de Gestão do Patrimônio Genético (CGEN) coordenou a elaboração de um anteprojeto de lei com o objetivo de substituir a Medida Provisória e regulamentar o Tratado Internacional sobre Recursos Fitogenéticos para a Alimentação e a Agricultura, aprovado pela Organização das Nações Unidas para a Alimentação e Agricultura em 2001 e ratificado pelo Brasil em 2006. O APL foi encaminhado à Casa Civil e, após alguns debates, foi submetido à consulta pública em 2007. Atualmente, o referido anteprojeto de lei se encontra na Casa Civil à espera de ser encaminhado pela Presidente da República ao Congresso Nacional. O objetivo deste estudo é realizar uma análise comparativa entre este anteprojeto de lei – elaborado pelo CGEN e que foi submetido à consulta pública pela Casa Civil – e a Medida Provisória 2.186-16/01, apontando os avanços obtidos e os pontos que ainda devem ser aperfeiçoados.

Anesthetic Neurotoxicity

Anesthetic Neurotoxicity

Variation in parathyroid hormone immunoassay results--a critical governance issue in the management of chronic kidney disease

Renal physicians strive to maintain parathyroid hormone (PTH) concentrations for patients with chronic kidney disease (CKD) within guideline limits, but poor method comparability means there is currently serious risk of clinical misclassification. The potential for under- or over-treatment is significant, representing a major challenge to patient safety. In the short-term, raising awareness of clinical implications of method-related differences in PTH is essential. Agreeing and adopting assay-specific PTH action limits for CKD patients as an interim measure is highly desirable and has been achieved in Scotland. Establishing pre-analytical requirements for PTH is also a priority. In the longer term, re-standardization of PTH methods in terms of an appropriate International Standard is required. Provided commutability can be demonstrated, the recently established IS 95/646 for PTH (1-84) is a suitable candidate. Establishment of a well-characterized panel of samples of defined clinical provenance to enable manufacturers to determine appropriate reference intervals and clinical decision points is also recommended and will provide an invaluable clinical resource. Recent developments in mass spectrometry mean that a candidate reference measurement procedure for PTH is now achievable and will represent major progress. Concurrently, evidence-based recommendations on clinical requirements and performance goals for PTH are required. Improving the comparability of PTH results requires support from many stakeholders but is achievable.

RS4 The Interim Cancer Drugs Fund - How To Not Spend £50 Million

The Cancer Drugs Fund (CDF) was established in April 2011 by the UK government, with a pledge of £200 million additional funding for each of the next 3 years to increase patient access to high cost oncology drugs in England. As an interim measure, £50 million was distributed between the 10 strategic health authorities (SHAs) in England to cover the 6 months from October 2010 to March 2011. This research aims to identify how the interim CDF (ICDF) was spent, and to discuss how this could impact utilization of the CDF. Data regarding the total funding allocated to each SHA from the ICDF and how much of this money had been spent by March 31, 2011 were obtained from SHA websites. Missing data were accessed through freedom of information requests. Overall, there were over 2700 applications to the fund, with an average approval rate of 91%. Over the 6 month period covered by the ICDF, approximately £21 million was spent across the 10 SHAs in England; this constituted 42% of the £50 million allocated. There was significant variation in the amount spent by each SHA; the highest under-spend was in the South West, where 75% of funds remained unallocated. Several SHAs reported the forecasted costs for continuing treatment beyond March 2011; these costs were incurred in the 2011/12 financial year and therefore were not covered by the ICDF. Remaining budget is expected to be reclaimed by the Department of Health. It is clear that there was a significant under-spend of the ICDF by all SHAs. It is concerning that many funding applications were rejected, despite the fact that almost half of the funds remained unallocated. Steps need to be taken to ensure more effective use of the CDF and to minimise the risk of regional variations in drug access.

Biodiversity Offsets: A Cost-Effective Interim Solution to Seabird Bycatch in Fisheries?

The concept of biodiversity offsets is well established as an approach to environmental management. The concept has been suggested for environmental management in fisheries, particularly in relation to the substantial numbers of non-target species—seabirds in particular—caught and killed as incidental bycatch during fishing activities. Substantial areas of fisheries are being closed to protect these species at great cost to the fishing industry. However, other actions may be taken to offset the impact of fishing on these populations at lower cost to the fishing industry. This idea, however, has attracted severe criticism largely as it does not address the underlying externality problems created by the fishing sector, namely seabird fishing mortality. In this paper, we re-examine the potential role of compensatory mitigation as a fisheries management tool, although from the perspective of being an interim management measure while more long-lasting solutions to the problem are found. We re-model an example previously examined by both proponents and opponents of the approach, namely the cost effectiveness of rodent control relative to fishery area closures for the conservation of a seabird population adversely affected by an Australian tuna fishery. We find that, in the example being examined, invasive rodent eradication is at least 10 times more cost effective than area closures. We conclude that, while this does not solve the actual bycatch problem, it may provide breathing space for both the seabird species and the industry to find longer term means of reducing bycatch.

Withdrawal from familial ovarian cancer screening for surgery: Findings from a psychological evaluation study (PsyFOCS)

ObjectiveA prospective psychological evaluation study of familial ovarian cancer screening (PsyFOCS) is underway in partnership with the UK Familial Ovarian Cancer Screening Study (UK FOCSS Phase 2). One of the aims of PsyFOCS is to examine factors associated with withdrawal from the UK FOCSS prior to the onset of 4-monthly screening. Method1999 of 3224 women completed a baseline questionnaire. 110 (5.5%) women withdrew from screening prior to their first routine Phase 2 screen, of which 73 (66.4% of withdrawals) had withdrawn because they had undergone removal of their ovaries and fallopian tubes (withdrawn group). The comparison group consisted of 1868 women who remained on screening. The baseline questionnaire included measures of cancer-specific distress, anxiety, depression and illness perceptions. ResultsLogistic regression analysis indicated that having had prior annual (Phase 1) screening (OR=13.34, p<.01), past experience of further tests (OR=2.37, p<.01) and greater cancer-specific distress (OR=1.38, p<.01) were associated with withdrawal for surgery. Belief in ageing as a cause of ovarian cancer was also associated with withdrawal (OR=1.32, p=.05). ConclusionThese cross-sectional data suggest that withdrawal from familial ovarian cancer screening may be influenced by both clinical and psychological factors. These may reflect women's experience of the drawbacks of screening and increased concern about ovarian cancer risk, as well as having opportunities to consider surgery as an alternative risk management strategy whilst using screening as an interim measure.

Change of HbA1c reporting to the new SI units

An international consensus statement recommends that dual reporting of haemoglobin A (HbA(1c)) levels--in the current units (percentage) and Système International (SI) units (mmol/mol)--be used as an interim measure for a 2-year transition period before progressing towards the use of SI units only. This recommendation is supported by the Australasian Association of Clinical Biochemists, the Australian Diabetes Educators Association, the Australian Diabetes Society and the Royal College of Pathologists of Australasia. The SI units are a true measure of HbA(1c) and remove potential confusion between HbA(1c) values and blood glucose values.

The Economics of the NHS Cancer Drugs Fund

In their 2010 election campaign, the Conservative party pledged to create a fund to provide access to cancer drugs that are recommended by doctors but that would not normally be reimbursed by the English NHS, either because the National Institute for Health and Clinical Excellence (NICE) recommended against their reimbursement, or because they have not yet been appraised by NICE. Elected to government in May 2010, the Conservatives, in coalition with the Liberal Democrats, have honoured their pledge and are increasing funding for cancer care. An initial fund of £50 million was introduced between October 2010 and April 2011, and a further £200 million per year has been allocated from April 2011 to 2014.[1] This is an interim measure until a 'value-based pricing' mechanism is introduced in 2014. Preferential funding of disease areas such as cancer without evidence of the efficiency may be politically advantageous, but it is likely to be inefficient, depriving potential patients of care from which they could benefit. One explanation of this special funding increase has been the use of comparative international tables of survival in cancer, which showed the NHS as lagging behind the achievements of other European countries.[2] During the Blair administration, NHS funding grew on average by 7% annually.[3] Some of these additional funds were targeted at areas where performance was deemed to be poor. Cancer was one of these areas. The current Coalition Government criticises the achievements of the Blair funding increase as failing to improve performance. Cancer mortality rates in the UK continue to be worse than many other European countries.[2] However, as highlighted by Appleby,[2] the focus should not be on absolute rates alone but on rates of change. He has shown that the Blair funding increases have taken time to impact but trends are clearly established and, for instance, in the next year, UK cancer mortality rates will be better than those of France. Cancer, for many, is a chronic condition in which good management can result in many additional years of good-quality life. Treatments, especially newer pharmaceuticals, are often expensive, as industry innovates and requires high prices for products that often offer only marginal improvements in outcomes for patients. Consequently, some of these products are not recommended by NICE as their benefits do not justify their costs. This is despite NICE already having a higher cost-per-QALY threshold for 'end-of-life' drugs.[4] The Cancer Drugs Fund not only undermines NICE decision making and weakens incentives for companies to price their products at a level that is affordable and justified by health improvements, but also singles out a particular disease for favourable treatment in an essentially arbitrary manner. The emotive power of this disease led politicians to capture support by singling it out for preference. Why favour cancer when there are so many other life-threatening and disabling diseases (such as heart disease, multiple sclerosis, respiratory disease, dementia and diabetes) that, through lobbies (often funded by sympathetic and commercially dependent pharmaceutical companies), clamour for more funding? One way of rationing scarce resources and prioritizing investments in a healthcare system is to focus on political advantage. …

KNOW ESSENTIALS: A tool for informed decisions in the absence of formal HTA systems

Most developing countries and resource-limited settings lack robust health technology assessment (HTA) systems. Because the development of locally relevant HTA is not immediately viable, and the extrapolation of external HTA is inappropriate, a new model for evaluating health technologies is required. The aim of this study was to describe the development and application of KNOW ESSENTIALS, a tool facilitating evidence-based decisions on health technologies by stakeholders in settings lacking formal HTA systems. Current HTA methodology was examined through literature search. Additional issues relevant to resource-limited settings, but not adequately addressed in current methodology, were identified through further literature search, appraisal of contextually relevant issues, discussion with healthcare professionals familiar with the local context, and personal experience. A set of thirteen elements important for evidence-based decisions was identified, selected and combined into a tool with the mnemonic KNOW ESSENTIALS. Detailed definitions for each element, coding for the elements, and a system to evaluate a given health technology using the tool were developed. Developing countries and resource-limited settings face several challenges to informed decision making. Models that are relevant and applicable in high-income countries are unlikely in such settings. KNOW ESSENTIALS is an alternative that facilitates evidence-based decision making by stakeholders without formal expertise in HTA. The tool could be particularly useful, as an interim measure, in healthcare systems that are developing HTA capacity. It could also be useful anywhere when rapid evidence-based decisions on health technologies are required.