World Health Organization Expert Research Articles

Mercury Levels in Human Hair and Farmed Fish near Artisanal and Small-Scale Gold Mining Communities in the Madre de Dios River Basin, Peru.

Artisanal and small-scale gold mining (ASGM) has been an important source of income for communities in the Madre de Dios River Basin in Peru for hundreds of years. However, in recent decades, the scale of ASGM activities in the region has increased dramatically, and exposures to a variety of occupational and environmental hazards related to ASGM, including mercury, are becoming more widespread. The aims of our study were to: (1) examine patterns in the total hair mercury level of human participants in several communities in the region and compare these results to the 2.2 µg/g total hair mercury level equivalent to the World Health Organization (WHO) Expert Committee of Food Additives (JECFA)’s Provisional Tolerable Weekly Intake (PTWI); and (2), to measure the mercury levels of paco (Piaractus brachypomus) fish raised in local aquaculture ponds, in order to compare these levels to the EPA Fish Tissue Residue Criterion of 0.3 µg Hg/g fish (wet weight). We collected hair samples from 80 participants in four communities (one control and three where ASGM activities occurred) in the region, and collected 111 samples from fish raised in 24 local aquaculture farms. We then analyzed the samples for total mercury. Total mercury levels in hair were statistically significantly higher in the mining communities than in the control community, and increased with increasing geodesic distance from the Madre de Dios headwaters, did not differ by sex, and frequently exceeded the reference level. Regression analyses indicated that higher hair mercury levels were associated with residence in ASGM communities. The analysis of paco fish samples found no samples that exceeded the EPA tissue residue criterion. Collectively, these results align with other recent studies showing that ASGM activities are associated with elevated human mercury exposure. The fish farmed through the relatively new process of aquaculture in ASGM areas appeared to have little potential to contribute to human mercury exposure. More research is needed on human health risks associated with ASGM to discern occupational, residential, and nutritional exposure, especially through tracking temporal changes in mercury levels as fish ponds age, and assessing levels in different farmed fish species. Additionally, research is needed to definitively determine that elevated mercury levels in humans and fish result from the elemental mercury from mining, rather than from a different source, such as the mercury released from soil erosion during deforestation events from mining or other activities.

Zika Virus and Birth Defects: Correlation or Causation?

Abstract Earlier this year, World Health Organization experts said that “a causal relationship between Zika infection during pregnancy and microcephaly is strongly suspected, though not yet scientifically proven”. How might scientists prove such a link?

The role of validated analytical methods in JECFA drug assessments and evaluation for recommending MRLs.

The Joint Food and Agriculture Organization and World Health Organization (FAO/WHO) Expert Committee on Food Additives (JECFA) is one of three Codex committees tasked with applying risk analysis and relying on independent scientific advice provided by expert bodies organized by FAO/WHO when developing standards. While not officially part of the Codex Alimentarius Commission structure, JECFA provides independent scientific advice to the Commission and its specialist committees such as the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) in setting maximum residue limits (MRLs) for veterinary drugs. Codex methods of analysis (Types I, II, III, and IV) are defined in the Codex Procedural Manual as are criteria to be used for selecting methods of analysis. However, if a method is to be used under a single laboratory condition to support regulatory work, it must be validated according to an internationally recognized protocol and the use of the method must be embedded in a quality assurance system in compliance with ISO/IEC 17025:2005. This paper examines the attributes of the methods used to generate residue depletion data for drug registration and/or licensing and for supporting regulatory enforcement initiatives that experts consider to be useful and appropriate in their assessment of methods of analysis. Copyright © 2016 Her Majesty the Queen in Right of Canada. Drug Testing and Analysis © 2016 John Wiley & Sons, Ltd.

ANALYSIS OF PREVALENCE, HOSPITALIZATION RATE AND MORTALITY LEVELS RELATED TO GASTROINTESTINAL DISORDERS IN THE MOSCOW REGION

Актуальность. По прогнозам экспертов Всемирной организации здравоохранения, к середине XXI в. заболевания органов пищеварения будут занимать одно из ведущих мест, что во многом обусловлено образом жизни современного человека (стрессы, нерациональное питание, гиподинамия, вредные привычки), загрязнением окружающей среды, увеличением в рационе питания доли некачественных и генномодифицированных продуктов питания.Цель – информационное обеспечение мероприятий по совершенствованию организации медицинской помощи больным с патологией желудочно-кишечного тракта и дальнейшему развитию специализированной гастроэнтерологической помощи населению Московской области, повышение ее доступности, эффективности и качества.Материал и методы. По состоянию за 2014 г. рассчитаны и проанализированы показатели, характеризующие заболеваемость (по обращаемости) основных возрастных контингентов населения (дети, подростки, взрослые) Московской области болезнями органов пищеварения, а также частота госпитализации и уровень больничной летальности. Источником информации послужили отчетные формы Федерального статистического наблюдения № 12 и № 14.Результаты. В 2014 г. в Московской области самый высокий уровень заболеваемости патологией желудочно-кишечного тракта зарегистрирован у подростков: на 42,7% выше, чем у взрослых, и на 11,7% выше, чем у детей.Ведущие причины обращаемости во всех возрастных группах – гастрит и дуоденит, а также болезни желчного пузыря, желчевыводящих путей. Среди особенностей структуры заболеваемости следует отметить высокую заболеваемость взрослых болезнями поджелудочной железы, язвой желудка и двенадцатиперстной кишки. Уровень госпитализации по поводу болезней органов пищеварения составил 17,8 случая на 1000 человек, в том числе по возрастным категориям: взрослые – 17,4‰, дети и подростки – 19,8‰. У взрослых основными причинами госпитализации были болезни поджелудочной железы (23,9% от всех случаев госпитализации в связи с болезнями органов пищеварения), болезни желчного пузыря и желчевыводящих путей (16,3%); у детей и подростков – болезни кишечника (36,4%), гастрит и дуоденит (17,9%). Больничная летальность взрослых от болезней органов пищеварения составила 3,3%, детей –0,02%.Заключение. Полученные статистические данные наряду с результатами анализа организации, качества и эффективности оказания медицинской помощи больным с патологией органов пищеварения могут быть использованы для совершенствования гастроэнтерологической помощи на всех уровнях и дальнейшего развития профильной службы на областном уровне.

An International Standard for holotranscobalamin (holoTC): international collaborative study to assign a holoTC value to the International Standard for vitamin B12 and serum folate.

Investigation of possible B12 and folate deficiencies requires measurement of these vitamins in serum. There is evidence that holotranscobalamin (holoTC), the active portion of B12 available to cells, is a more specific marker of early B12 deficiency than total B12. The availability of immunoassays for holoTC prompted an international collaborative study to assign a holoTC value to the World Health Organization (WHO) 1st International Standard (IS) for vitamin B12 and serum folate, 03/178. The IS, 03/178, and three serum samples with different holoTC levels were assayed by 12 laboratories in eight countries using manual and automated immunoassays for holoTC; one laboratory additionally performed an in-house assay. Fourteen sets of data were analysed. Overall, the IS, 03/178, and the three serum samples demonstrated assay linearity and parallelism. An overall geometric mean (GM) holoTC value of 106.8 pmol/L was obtained for 03/178, with an inter-laboratory geometric coefficient of variation (GCV) of 10.5%. There was a reduction in inter-laboratory variability when the holoTC levels in the serum samples were determined relative to the IS with an assigned holoTC value rather than to the assays' calibration. Accelerated degradation studies showed that 03/178 was sufficiently stable to serve as an IS for holoTC. The WHO Expert Committee on Biological Standardization endorsed the proposal to assign a holoTC value of 107 pmol/L to 03/178, corresponding to 0.107 pmol per ampoule, for use as the 1st IS for vitamin B12, serum folate, and holoTC.

Survey of Ambient Air Pollution Health Risk Assessment Tools.

Designing air quality policies that improve public health can benefit from information about air pollution health risks and impacts, which include respiratory and cardiovascular diseases and premature death. Several computer-based tools help automate air pollution health impact assessments and are being used for a variety of contexts. Expanding information gathered for a May 2014 World Health Organization expert meeting, we survey 12 multinational air pollution health impact assessment tools, categorize them according to key technical and operational characteristics, and identify limitations and challenges. Key characteristics include spatial resolution, pollutants and health effect outcomes evaluated, and method for characterizing population exposure, as well as tool format, accessibility, complexity, and degree of peer review and application in policy contexts. While many of the tools use common data sources for concentration-response associations, population, and baseline mortality rates, they vary in the exposure information source, format, and degree of technical complexity. We find that there is an important tradeoff between technical refinement and accessibility for a broad range of applications. Analysts should apply tools that provide the appropriate geographic scope, resolution, and maximum degree of technical rigor for the intended assessment, within resources constraints. A systematic intercomparison of the tools' inputs, assumptions, calculations, and results would be helpful to determine the appropriateness of each for different types of assessment. Future work would benefit from accounting for multiple uncertainty sources and integrating ambient air pollution health impact assessment tools with those addressing other related health risks (e.g., smoking, indoor pollution, climate change, vehicle accidents, physical activity).

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for terbuthylazine in light of confirmatory data

EFSA Supporting PublicationsVolume 13, Issue 1 919E Technical reportOpen Access Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for terbuthylazine in light of confirmatory data European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 20 January 2016 https://doi.org/10.2903/sp.efsa.2016.EN-919Citations: 2 Published date: 20 January 2016 Question number: EFSA-Q-2015-00735 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat References ECHA (European Chemicals Agency), 2015. Committee for Risk Assessment (RAC) Opinion proposing harmonised classification and labelling at EU level of terbuthylazine. [CLH-0-0000001412-86-66/F]. Adopted in 5 June 2015 EFSA (European Food Safety Authority), 2011. Conclusion on the peer review of the pesticide risk assessment of the active substance terbuthylazine. The EFSA Journal 2011; 9(1):1969, 133 pp. doi:10.2903/j.efsa.2011.1969. Available online: www.efsa.europa.eu/efsajournal.htm EFSA Panel on Contaminants in the Food Chain (CONTAM) and EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), 2010. Scientific Opinion on Melamine in Food and Feed. EFSA Journal 2010; 8(4):1573. 145 pp. doi:10.2903/j.efsa.2010.1573. Available online: www.efsa.europa.eu/efsajournal.htm European Commission, 2013. Guidance document on the procedures for submission and assessment of confirmatory information following approval of an active substance in accordance with Regulation (EC) No 1107/2009. SANCO 5634/2009-rev. 6.1 WHO (World Health Organization), 2009a. Toxicological and Health aspects of melamine and cyanuric acid. Report of a WHO expert meeting in collaboration with FAO. Supported by Health Canada Citing Literature Volume13, Issue1January 2016919E ReferencesRelatedInformation

Risk of Coronary Heart Disease in Different Criterion of Impaired Fasting Glucose: A Meta-Analysis.

The cut-point for diagnosing impaired fasting glucose (IFG) had been dispute, as reports about the associated clinical events are inconsistent. This meta-analysis evaluated the risk of coronary heart disease (CHD) in association with different criterion of IFG according to the American Diabetes Association (ADA) or the World Health Organization (WHO) Expert Group. We included prospective cohort studies with multivariate-adjusted data on IFG and CHD for analysis. The relative risks (RRs) of CHD were calculated and reported with 95% confidence intervals (95% CIs). Seventeen prospective cohort studies, comprising 527,021 individuals were included. The risks of CHD were increased in both participants with IFG defined as the ADA or WHO criterion (RR 1.11, 95% CI 1.02-1.21; and RR 1.18, 95% CI 1.10-1.28, respectively). Subgroup analyses showed that in both definition of IFG, the risk of CHD was only increased in studies with possibility of enrolling patients with increased 2 hours plasma glucose (2-h PG), or in studies with inadequate adjustment, but not in studies excluded participants with increased 2-h PG or in those with adequate adjustment of other risk factors. Our meta-analysis demonstrates that the presence of IFG was significantly associated with future risk of CHD. The risk of CHD was increased when fasting plasma glucose was as low as 100 mg/dL according to the lower cut-point of IFG by the ADA criterion. However, the risk maybe confounded by the undetected increased 2-h PG or other cardiovascular risk factors.

Delamanid expanded access novel treatment of drug resistant tuberculosis.

Tuberculosis (TB) remains a global emergency and is one of the most common infectious disease causes of death in developing countries. Current treatment regimens for multi-drug resistant TB are associated with low treatment success rates, are toxic, and require long duration of treatment. The need for shorter and more effective treatment regimens is urgent. Delamanid (Deltyba, or formerly known as OPC-67683) is a new dihydro-imidazooxazole anti-TB drug active against resistant forms of pulmonary TB. Delamanid kills Mycobacterium tuberculosis by inhibiting the synthesis of mycolic acids required for cell wall synthesis. Whilst delamanid has been included in the WHO Model List of Essential Medicine by the World Health Organization Expert Committee on Selection and Use of Essential Medicines and in international guidance for the treatment of multi-drug resistant TB since April 2014, its access in countries with the greatest need, has proven challenging. This review provides an update on currently available clinical safety and efficacy data on delamanid and offers a discussion on research priorities and recommendations for expedited, expanded access.

Is general practice engaged with physical activity promotion?

The many positive benefits of regular physical activity (PA) and resultant increased cardiorespiratory fitness on improved health are widely acknowledged.1 GPs are in a unique position to engage the public in PA given their access across local communities, particularly less healthy populations, older people, and those with lower socioeconomic status, and they provide a trusted source of advice. Currently there is a lack of engagement from primary care physicians in following PA promotion clinical guidelines, with barriers against best clinical practice including a lack of time, education and resources. Comprehensive, multisectoral strategies are needed to reverse the physical inactivity pandemic. Engaging GPs in PA promotion alone will not reverse current trends. Other approaches that are needed to increase PA levels include: school-based methods that incorporate physical literacy, improved urban design planning, and active transport policies, to name a few.2 ### The physical inactivity pandemic Given the current burden of chronic non-communicable diseases in the UK, a greater emphasis needs to be placed on chronic disease prevention and treatment through regular PA. Improving patient PA levels could save approximately 5.3 million lives worldwide,3 and over £8 billion4 for the UK economy each year. The World Health Organization (WHO) cite physical inactivity as the fourth leading risk factor for global mortality causing an estimated 6% of deaths globally. UK levels of physical inactivity are among the highest worldwide. When asked, only about one-third of UK adults reported meeting the Chief Medical Officer’s (CMO’s) PA guidelines to confer even basic health benefits.1 Alarmingly, when a subsample of these adults had their PA levels objectively measured with an accelerometer only 5% met the CMO’s PA guidelines.5 ### Structural incorporation of physical activity promotion in primary care ‘Investments that work for physical activity’, supported by the WHO and numerous global experts, and organisations, concludes that integrating PA promotion into primary healthcare systems is one …

Evaluating the quality and use of economic data in decisions about essential medicines.

ObjectiveTo evaluate the quality of economic data provided in applications to the World Health Organization (WHO) Model List of Essential Medicines and to evaluate the role of these data in decision-making by the expert committee that considers the applications.MethodsWe analysed applications submitted to the WHO Expert Committee on the Selection and Use of Essential Medicines between 2002 and 2013. The completeness of data on the price and cost–effectiveness of medicines was extracted from application documents and coded using a four-point scale. We recorded whether or not the expert committee discussed economic information and the outcomes of each application. Associations between the completeness of economic data and application outcomes were assessed using χ2 tests.FindingsThe expert committee received 134 applications. Only eight applications (6%) included complete price data and economic evaluation data. Many applicants omitted or misinterpreted the economic evaluation section of the application form. Despite the lack of economic data, all applications were reviewed by the committee. There was no significant association between the completeness of economic information and application outcomes. The expert committee tried to address information gaps in applications by further review and analysis of data related to the application.ConclusionThe World Health Organization should revise the instructions to applicants on economic data requirements; develop new mechanisms to assist applicants in completing the application process; and define methods for the use of economic data in decision-making.

Implementation workshop of WHO guidelines on evaluation of malaria vaccines: Current regulatory concepts and issues related to vaccine quality, Pretoria, South Africa 07 Nov 2014

The current World Health Organization (WHO) guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum were adopted by the WHO Expert Committee on Biological Standardization in 2012 to provide guidance on the quality, nonclinical and clinical aspects of recombinant malaria vaccines. A WHO workshop was organised to facilitate implementation into African (national/regional) regulatory practices, of the regulatory evaluation principles outlined in the guidelines regarding quality aspects. The workshop was used also to share knowledge and experience on regulatory topics of chemistry, manufacturing and control with a focus on vaccines through presentations and an interactive discussion using a case study approach. The basic principles and concepts of vaccine quality including consistency of production, quality control and manufacturing process were presented and discussed in the meeting. By reviewing and practicing a case study, better understanding on the relationship between consistency of production and batch release tests of an adjuvanted pre-erythrocytic recombinant malaria vaccine was reached. The case study exercise was considered very useful to understand regulatory evaluation principles of vaccines and a suggestion was made to WHO to provide such practices also through its Global Learning Opportunities for Vaccine Quality programme.

Scientific Opinion on the re‐evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives

The Panel on Food Additives and Nutrient Sources added to Food (ANS) re-evaluated the safety of polysorbate 20 (E 432), polysorbate 80 (E 433), polysorbate 40 (E 434), polysorbate 60 (E 435) and polysorbate 65 (E 436) as food additives. The Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) derived an Acceptable Daily Intake (ADI) of 25 mg/kg body weight (bw)/day (group ADI for polysorbates 20, 40, 60, 65 and 80) and the Scientific Committee on Food (SCF) derived a group ADI of 10 mg/kg bw/day. Small amounts of polyoxyethylene sorbitans are absorbed. Similar toxicokinetics would be expected for all polysorbates based on their similarities in structure and metabolic fate. The acute toxicity is very low. There is no concern regarding genotoxicity, carcinogenicity or developmental toxicity. From a limited number of studies, there is no indication of reproductive toxicity. The Panel considered the long-term carcinogenicity study in rats with a No Observed Adverse Effect Level (NOAEL) equivalent to 2 500 mg/kg bw/day – consistent with the NOAEL defined in subchronic studies – as the key study and allocated a group ADI of 25 mg/kg bw/day using an uncertainty factor of 100. The estimated exposure of toddlers at the highest level in non-brand loyal scenario remains very close to the ADI (24.5 mg/kg bw/day). The Panel is aware that for three food categories no reported uses have been obtained and that other dietary sources of exposure to polysorbates could not been considered in this opinion and therefore more data (usage and analytical data) are needed to decrease uncertainties in the refined exposure assessment scenario used.

World Health Organization International Standard To Harmonize Assays for Detection of Mycoplasma DNA.

Nucleic acid amplification technique (NAT)-based assays (referred to here as NAT assays) are increasingly used as an alternative to culture-based approaches for the detection of mycoplasma contamination of cell cultures. Assay features, like the limit of detection or quantification, vary widely between different mycoplasma NAT assays. Biological reference materials may be useful for harmonization of mycoplasma NAT assays. An international feasibility study included lyophilized preparations of four distantly related mycoplasma species (Acholeplasma laidlawii, Mycoplasma fermentans, M. orale, M. pneumoniae) at different concentrations which were analyzed by 21 laboratories using 26 NAT assays with a qualitative, semiquantitative, or quantitative design. An M. fermentans preparation was shown to decrease the interassay variation when used as a common reference material. The preparation was remanufactured and characterized in a comparability study, and its potency (in NAT-detectable units) across different NATs was determined. The World Health Organization (WHO) Expert Committee on Biological Standardization (ECBS) established this preparation to be the "1st World Health Organization international standard for mycoplasma DNA for nucleic acid amplification technique-based assays designed for generic mycoplasma detection" (WHO Tech Rep Ser 987:42, 2014) with a potency of 200,000 IU/ml. This WHO international standard is now available as a reference preparation for characterization of NAT assays, e.g., for determination of analytic sensitivity, for calibration of quantitative assays in a common unitage, and for defining regulatory requirements in the field of mycoplasma testing.

On the road to elimination of Rhodesiense human African trypanosomiasis: first WHO meeting of stakeholders.

On the road to elimination of Rhodesiense human African trypanosomiasis: first WHO meeting of stakeholders.

WHO consultation on clinical evaluation of vaccines, 17–18 July 2014, WHO Headquarters, Geneva, Switzerland

A World Health Organization (WHO) consultation on guidelines for National Regulatory Authorities (NRAs) and vaccine manufacturers on clinical evaluation of vaccines was held from 17 to 18 July 2014, to review key scientific challenges that regulators have been facing since the establishment of the WHO Guidelines on Clinical Evaluation of Vaccines. The guidelines, adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2001, have served as the basis for setting or updating national requirements for the evaluation and licensing of a broad range of vaccines as well as for WHO vaccine prequalification. Regulators from Australia, Brazil, China, Canada, Germany, India, Republic of Korea, South Africa, United States of America and the United Kingdom were represented. The International Federation for Pharmaceutical Manufacturers’ Association (IFPMA) and the Developing Country Vaccine Manufacturers’ Network (DCVMN) provided industry representation.The consultation concluded that the guidelines should be revised to address issues that were raised in the context of vaccines that were the subject of clinical development in the past decade. Although the current guidelines have served well over time, it was recognized that an update would further increase their utility and would help regulators, manufacturers, vaccine developers and academia to respond to the challenging questions regarding the safety, immunogenicity, efficacy and effectiveness of vaccines intended for global use. A summary of the main outcomes of the consultation and proposals for the next steps regarding the guidelines and beyond are provided in this report.

Postpandemic H1N1 influenza infection in ICU: Are we any wiser now?

Postpandemic H1N1 influenza infection in ICU: Are we any wiser now?

Role of Mindfulness‐Based Cognitive Therapy in Alleviating Psychological Distress among Cancer Patients

The purpose of this research was to examine the research literature on role of Mindfulness-Based Cognitive Therapy in alleviating psychological distress among cancer patients. World Health Organization and medical experts have expressed alarm about constantly the growing problem of cancer patients in the world. The researcher emphasize that the diagnosis of cancer not only has obvious physical ramifications for the patient, but also the trauma of a diagnosis produces psychological problem such as somewhat hardly manageable distress as well, and in the face of psychological stressors that negatively impact the patient’s overall quality of life. The present study examined the results of various studies, for identifying the potential efficacy of MBCT as it could be applied to patients with cancer which presents psychological distress. Research on Mindfulness-Based Cognitive Therapy has supported the safety and effectiveness of this approach might be used with distress associated problems among cancer patients also other studies obtained results signified the effectiveness of this therapy while dealing with cancer patients showed significant impact in alleviating different type of problems associated with this disease. It suggests need for a comprehensive solution that combines medical, psychological, social and behavioral approach to this complex problem in initiating the distress of cancer patients.

Ethical allocation of drugs and vaccines in the West African ebola epidemic.

The West African epidemic of Ebola virus disease (EVD) is spiraling out of control, with an exponential increase in cases, projected to infect 10,000 people per week by December.1 Despite the rising death toll and regional spread, a major international response did not occur until 2 US aid workers and a Spanish priest were treated with the investigational drug ZMapp, a monoclonal antibody developed by Mapp Biopharmaceutical. Vaccines and drugs that have never been tested in humans, and are in scarce supply, could never have contained this outbreak. Nonetheless, what if good evidence emerged demonstrating their safety and efficacy? What would be an ethical method of allocating scarce beneficial resources? The apparent preference given to foreign aid workers over West Africans provoked a firestorm. Before discussing the ethical allocation of scarce drugs, we should ask a more fundamental question: Why did it take nearly 40 years after the first outbreak in 1976 to launch clinical trials? After more than 20 outbreaks of EVD and 5 months after its international spread, governments and industry have begun to ramp up research, with expedited regulatory processes and clinical protocols. On September 5, 2014, a World Health Organization (WHO) expert committee reviewed, and vowed to accelerate development of, promising drug and vaccine candidates, including blood transfusions from recovered Ebola patients and antibody treatments.2 Days earlier, the National Institutes of Health (NIH) launched vaccine safety trials, and preliminary clinical trial results for a GlaxoSmithKline vaccine are expected by November. The US Department of Health and Human Services promised Mapp Biopharmaceutical up to $42.3 million to develop ZMapp. Although these therapeutic agents offer some hope, with Ebola treatment centers currently overwhelmed, the global community must assist countries in building domestic health systems. Countries will require more human resources and technical assistance with, for example, transfusing whole blood, plasma, or serums derived from recovered Ebola patients. At the same time, the global community must help transport and deliver therapeutics to local facilities, while rigorously maintaining a cold-storage supply chain. Many factors have dissuaded investment in EVD countermeasures. Ebola outbreaks are sporadic, with an unpredictable market for interventions. These outbreaks typically occur in countries ranked lowest in economic development, which cannot afford the high price of patented medications. Rich countries have had other international funding priorities that better reflect the global burden of disease (eg, AIDS, tuberculosis, and malaria). But EVD has epidemic potential, and once it takes hold in highly congested, impoverished, capital cities, it can spread exponentially. The West African epidemic has provoked a public health crisis and a security threat, further weakening economically and politically fragile states. The UN Security Council should act boldly to ameliorate the crisis, with Secretary-General Ban Ki-moon framing the mobilization as “an international rescue call.”3

Distribution of Heavy Metals in Muscles and Internal Organs of Korean Cephalopods and Crustaceans: Risk Assessment for Human Health

Samples of seven species of cephalopods and crustaceans were collected from major fish markets on the Korean coast and analyzed for mercury (Hg) using a direct Hg analyzer and for the metals cadmium (Cd), lead (Pb), chromium, silver, nickel, copper, and zinc using inductively coupled plasma mass spectrometry. The distributions of heavy metals in muscles, internal organs, and whole tissues were determined, and a risk assessment was conducted to provide information concerning consumer safety. The heavy metals accumulated to higher levels (P < 0.05) in internal organs than in muscles for all species. The mean concentrations of Cd, which had the highest concentrations of the three hazardous metals (Cd, Pb, and Hg), in all internal organs (except those of blue crab) exceeded the regulatory limits set by Korea and the European Union. The Cd concentrations in all whole tissues of squid and octopus (relatively large cephalopods), red snow crab, and snow crab exceeded the European Union limits. The estimated dietary intake of Cd, Pb, and Hg for each part of all species accounted for 1.73 to 130.57%, 0.03 to 0.39%, and 0.93 to 1.67%, respectively, of the provisional tolerable daily intake adopted by the Joint Food and Agriculture Organization and World Health Organization Expert Committee on Food Additives; the highest values were found in internal organs. The hazard index (HI) is recognized as a reasonable parameter for assessing the risk of heavy metal consumption associated with contaminated food. Because of the high HI (>1.0) of the internal organs of cephalopods and the maximum HI for whole tissue of 0.424, consumers eating internal organs or whole tissues of cephalopods could be at risk of high heavy metal exposure. Therefore, the internal organs of relatively large cephalopods and crabs (except blue crab) are unfit for consumption. However, consumption of flesh after removing internal organs is a suitable approach for decreasing exposure to harmful metals.