Unanticipated Risks Research Articles

The Food and Drug Administration and the Future of Drug Development for the Treatment of Diabetes.

The U.S. Food and Drug Administration (FDA) regulates the marketing of drugs in the United States. The FDA staff faces substantial challenges in evaluating preclinical and clinical trial data for a proposed new drug and deciding whether the resultant benefit-risk assessment supports marketing approval. Any approval decision will be associated with uncertainty regarding the drug's true risks and benefits because of the inherent limits of testing in pre-approval development programs, the sample sizes included in clinical trials, and the structured environment of clinical trials versus patterns of use in general clinical practice. Indeed, the only way to completely avoid the occurrence of unanticipated risks after drug approval would be to stop approving new drugs. How the FDA deals with this uncertainty in benefit-risk assessment will profoundly affect treatment options for people with diabetes and for the health care professionals who care for them. The challenges facing the FDA in the field of diabetes have been all too well illustrated in recent years. After many years of treating patients with a relatively limited pharmacological armamentarium, the past 20 years have witnessed the discovery of new drug targets and the development of new therapeutic options for people with diabetes. However, the risks of rapid advances have also become apparent. The introduction of thiazolidinediones was greeted with excitement because of their potential to change treatment paradigms. The subsequent withdrawal of troglitazone because of hepatotoxicity concerns made clear the potential hazards of early adoption of new drugs.1 In 2007, analyses suggesting that rosiglitazone increased cardiovascular event rates in people with type 2 diabetes2 caused concern among both patients and physicians. Subsequent publications and regulatory reviews motivated by the rosiglitazone analyses fundamentally changed the landscape for diabetes drug development. Cardiovascular events, including myocardial infarctions (MIs) and stroke, are major causes of mortality and …

Technological affordances of risk and blame: the case of the electronic prescription service in England

Information and communication technology (ICT) is often presented by health policymakers and software designers as a means for reducing clinical risk, leading to safer clinical practice. Studies have challenged this view, showing how technology can produce new or unanticipated risks. Although research seeks to objectively identify these risks, we recognise that technological risks are socially constructed through the interaction of technology and practice. The aim of this article is to explore how technology affords opportunities for the social construction and control of risk in health care settings. Drawing upon a study of the electronic prescription service introduced in the National Health Service in England, we make three arguments. Firstly, as technology interacts with social practice (for example, through policy and the design and use of ICT) it affords opportunities for the construction of risk through its interpretive flexibility, transformative capacity and materiality. Secondly, social actors interpret these risks within and across professional boundaries and cultures. Thirdly, the social construction of risk affords certain implications to policymakers, designers and users of health ICT, specifically a reordering of power and responsibility and a recasting of questions of blame. These, in turn, raise questions concerning the boundaries and bearers of responsibility.

Health risks, travel preparation, and illness among public health professionals during international travel

Few data currently exist on health risks faced by public health professionals (PHP) during international travel. We conducted pre- and post-travel health surveys to assess knowledge, attitudes, and practices (KAP), and illnesses among PHP international travelers. Anonymous surveys were completed by PHP from a large American public health agency who sought a pre-travel medical consult from September 1, 2009, to September 30, 2010. Surveys were completed by 122 participants; travelers went to 163 countries. Of the 122 respondents, 97 (80%) reported at least one planned health risk activity (visiting rural areas, handling animals, contact with blood or body fluids, visiting malarious areas), and 50 (41%) reported exposure to unanticipated health risks. Of the 62 travelers who visited malarious areas, 14 (23%) reported inconsistent or no use of malaria prophylaxis. Illness during travel was reported by 33 (27%) respondents. Most of the PHP travelers in our study reported at least one planned health risk activity, and almost half reported exposure to unanticipated health risks, and one-quarter of travelers to malarious areas reported inconsistent or no use of malaria chemoprophylaxis. Our findings highlight that communication and education outreach for PHP to prevent travel-associated illnesses can be improved.

250 Robotic Pancreatic Resections

Computer-assisted robotic surgery allows complex resections and anastomotic reconstructions to be performed with nearly identical standards to open surgery. We applied this technology to a variety of pancreatic resections to assess the safety, feasibility, versatility, and reliability of this technology. A retrospective review of a prospective database of robotic pancreatic resections at a single institution between August 2008 and November 2012 was performed. Perioperative outcomes were analyzed. A total of 250 consecutive robotic pancreatic resections were analyzed; pancreaticoduodenectomy (132), distal pancreatectomy (83), central pancreatectomy (13), pancreatic enucleation (10), total pancreatectomy (5), Appleby resection (4), and Frey procedure (3). Thirty-day and 90-day mortality was 0.8% and 2.0%. Rate of Clavien 3 and 4 complications was 14% and 6%. The International Study Group on Pancreatic Fistula grade C fistula rate was 4%. Mean operative time for the 2 most common procedures was 529 ± 103 minutes for pancreaticoduodenectomy and 257 ± 93 minutes for distal pancreatectomy. Continuous improvement in operative times was observed over the course of the experience. Conversion to open procedure was required in 16 patients (6%) (11 with pancreaticoduodenectomy, 2 with distal pancreatectomy, 2 with central pancreatectomy, 1 with total pancreatectomy) for failure to progress (14) and bleeding (2). This represents to our knowledge the largest series of robotic pancreatic resections. Safety and feasibility metrics including the low incidence of conversion support the robustness of this platform and suggest no unanticipated risks inherent to this new technology. By defining these early outcome metrics, this report begins to establish a framework for comparative effectiveness studies of this platform.

Risk perceptions and approaches in multi-organizations: A research review 2000–2012

Shared risks and opportunities set specific premises for risk management (RM) in temporary multi-organizations (TMOs). However, most project RM research is presented from the perspective of a single-organizational project delivery team or covers limited risk perceptions and RM approaches. This paper aims to address how well the body of knowledge on multi-organizational RM corresponds to a state-of-art understanding on project RM and to identify which gaps need to be addressed in future research. The review involves: 1) the preferred view of risk as threat and/or opportunity, 2) the nature of addressed risks as anticipated or unanticipated risks or unrealistic assumptions, 3) the role of the multi-organization as the source of risks and/or resources for risk management (RM), and 4) the allocation of risk responsibilities. The review covers research papers published between 2000 and 2012 in four journals: International Journal of Project Management (IJPM), Project Management Journal (PMJ), Journal of Construction Engineering and Management (JCEM), and IEEE Transactions on Software Engineering (TSE). 105 eligible research papers were identified. The results and conclusion outline the identified main gaps in multi-organizational RM research compared to the state-of-art RM research and TMO-specific characteristics. The results can be used to inform research agendas on more holistic and dynamic multi-organizational RM concepts.

Revamping occupational safety and health training: Integrating andragogical principles for the adult learner

Despite attempts to improve safety performance, the construction industry continues to account for a disproportionate rate of injuries. A large proportion of these injuries occur because workers are unable to recognize and respond to hazards in dynamic and unpredictable environments. Unrecognized hazards expose workers to unanticipated risks and can lead to catastrophic accidents. In order to enhance hazard recognition skills, employers often put new and experienced workers through formal hazard recognition training programs. Unfortunately, current training programs primarily rely on instructor-centric pedagogical approaches, which are insensitive to the adult learning process. In order to ensure effective adult learning, training programs must integrate learner-centric andragogical principles to improve engagement and retention in adult trainees. This paper aims to discuss training program elements that can potentially accelerate the adult learning process while improving safety knowledge retention. To this end, the researchers reviewed relevant literature on the cognitive processes of adult learning, essential components of effectual training programs and developed a reliable framework for the training and transfer of safety knowledge. A case example of successfully using the framework is also presented. The results of the study will provide safety trainers and construction professionals with valuable information on developing effective hazard recognition and receptor training programs, with the goal of improving construction safety performance.

Risk Management: History, Definition, and Critique

AbstractThe study of risk management began after World War II. Risk management has long been associated with the use of market insurance to protect individuals and companies from various losses associated with accidents. Other forms of risk management, alternatives to market insurance, surfaced during the 1950s when market insurance was perceived as very costly and incomplete for protection against pure risk. The use of derivatives as risk management instruments arose during the 1970s, and expanded rapidly during the 1980s, as companies intensified their financial risk management. International risk regulation began in the 1980s, and financial firms developed internal risk management models and capital calculation formulas to hedge against unanticipated risks and reduce regulatory capital. Concomitantly, governance of risk management became essential, integrated risk management was introduced, and the chief risk officer positions were created. Nonetheless, these regulations, governance rules, and risk management methods failed to prevent the financial crisis that began in 2007.

Risk Management: History, Definition and Critique

The study of risk management began after World War II. Risk management has long been associated with the use of market insurance to protect individuals and companies from various losses associated with accidents. Other forms of risk management, alternatives to market insurance, surfaced during the 1950s when market insurance was perceived as very costly and incomplete for protection against pure risk. The use of derivatives as risk management instruments arose during the 1970s, and expanded rapidly during the 1980s, as companies intensified their financial risk management. International risk regulation began in the 1980s, and financial firms developed internal risk management models and capital calculation formulas to hedge against unanticipated risks and reduce regulatory capital. Concomitantly, governance of risk management became essential, integrated risk management was introduced and the chief risk officer positions were created. Nonetheless, these regulations, governance rules and risk management methods failed to prevent the financial crisis that began in 2007.

Docetaxel induced interstitial pneumonitis: a case report

Incidence of diffuse alveolar damage is rarely seen after administration of docetaxel used alone or in combination with other chemotherapeutic drugs in absence of radiation. Here we present one such patient who developed diffuse alveolar pneumonitis after administration of first dose of docetaxel and the patient responded to steroids rather than antibiotics and antifungal drugs confirming the cause. This rapid onset drug induced alveolar pneumonitis illustrates that no therapeutic intervention is without its intrinsic and unanticipated risks.

Pneumonitis and pulmonary fibrosis in a patient receiving adjuvant docetaxel and cyclophosphamide for stage 3 breast cancer: a case report and literature review

IntroductionPulmonary toxicities associated with chemotherapeutic agents utilized as adjuvant therapy in patients with breast cancer are distinctly uncommon. The chemotherapy regimen of docetaxel/cyclophosphamide has a more favorable therapeutic index compared to anthracycline-based regimens due to a significantly lower incidence of heart failure and leukemia. Consequently, docetaxel/cyclophosphamide is the preferred adjuvant chemotherapy of choice in older women or in women where anthracyclines may be contraindicated. Pulmonary complications in patients with breast cancer receiving taxane-based adjuvant chemotherapy in the absence of radiation are distinctly uncommon. Here, we report the case of a patient receiving adjuvant docetaxel/cyclophosphamide who developed rapid-onset, biopsy-proven interstitial pneumonitis.Case presentationA 72-year-old Hispanic woman was diagnosed as having stage 3 hormone-receptor positive, human epidermal growth factor receptor 2/neu negative, invasive breast cancer. Due to the estimated 10-year risk of recurrence of approximately 80 percent, a decision was made to treat our patient with adjuvant chemotherapy. Due to her age and increased risk of cardiac toxicity with anthracycline-based chemotherapy regimens, our patient was treated with docetaxel/cyclophosphamide chemotherapy for a total of four planned cycles. However, approximately two weeks after receiving the third cycle of chemotherapy, our patient developed rapidly progressive dyspnea, and a non-productive cough and went to the emergency room at an outside medical facility. She was found to have mild hypoxemia, and new onset of peripheral, subpleural fibrotic changes not present on pre-treatment scans. A thorascopic-guided wedge biopsy of the lung tissue revealed subacute interstitial pneumonitis. Our patient made a rapid clinical recovery after treatment with corticosteroids.ConclusionsInterstitial pneumonitis is a rare complication of docetaxel/cyclophosphamide chemotherapy that carries a high mortality rate. The only way to make a definitive diagnosis is with a wedge biopsy of the lung, which should be performed when feasible. Our patient’s case illustrates that no therapeutic intervention is without its intrinsic and unanticipated risks, and interstitial pneumonitis should be discussed as a potential side effect with all patients prior to administering docetaxel/cyclophosphamide chemotherapy.

Bribery and Corruption in Telecommunications – Best Practice in Prevention and Remedies

This paper analyses a collection of cases of corruption in telecommunications to identify failings and best practice in legislation, regulation and practice, plus measures to reduce occurrences. The Washington Consensus as applied to telecommunications creating efficient and competitive markets that would better meet the needs of consumers and businesses, while supporting economic development and avoiding being a burden on the taxpayer. The recipe contained significant but, apparently, unanticipated risks of and opportunities for holders of public office to make private and illegal gains. No measures were put in place to contain or to detect the corruption, with the result that individual cases came to light only slowly. The current trials in India concerning the “2G spectrum scam” and the settlement by Siemens AG with prosecutors in Germany and the USA are the most conspicuous examples. Work to bolster anti-corruption efforts in developing countries has been separate from support for reform in telecommunications, with no special attention given to the sector. The traditional form of corruption was in procurement, with payments for contracts for network equipment. Purchasing shifted to private-sector operators, supposedly disciplined by investors and markets against corrupt practices. The risks of corruption were raised by all three telecommunications pillars of the Washington Consensus. Liberalisation required the issuance of new licences which were assigned in whole or in part to family members, cronies and to bribe payers. Licence conditions could be varied by bribes – buying lower levels of competition or exclusivity. Privatisation has seen the sale to cronies and bribe payers. Often the price was raised and with it the bribes by sweetening the terms (e.g., adding a wireless licence). Policy and regulation have both been controlled by operators, by bribes and regulatory capture. Action within the sector is now essential first to identify and then implement best practice in the avoidance and elimination of corruption. Transparency in ownership requires disclosure of the beneficial owners of operators, avoiding the anonymity of holding companies in tax havens, to reduce the problems of stakes being assigned to the family and cronies of politicians. Major multi-national groups should identify their minority “business partners”, which they have avoided by terms such as “local investors”. Registers of the financial interests of heads of state, ministers, members of parliament, and senior officials are essential, with penalties for errors and criminal sanctions for unexplained accumulation of assets. Key individuals, such as heads of state, ministers of communications and regulators should be precluded from holding financial interests in the sector. A further area where transparency is required is in payments made for privatisation and for licences. All payments should be fully declared so that records can be checked against expenditure. Systems of governance for telecommunications must reflect the risks of corruption. Any remaining public procurement contracts need to be subject to strict rules, with a high level of transparency. Similar practices are required for development aid, to ensure that any money is identified and the terms made clear. The success of the US Foreign Corrupt Practices Act combined with the Securities Exchange Act point to the need for detailed accounting rules, with published audited reports – country by country – and strict obligations to investigate malfeasance. Provision must also be made to protect whistleblowers. Ministries and regulators need to adopt integrity policies including explicit anti-bribery rules, with training, signed annual declarations by key individuals and robust protection for whistleblowing. They also need to ensure transparency of their own accounts, to show payments received from operators and its disbursement or retention (e.g., in universal service or rural subsidy funds), this includes remuneration and benefits paid to senior officials. A range of practices in better regulation can be adopted to reduce the risks of corruption, including annual work plans, key performance indicators, annual reports to parliament, impact assessments for proposed measures, consultations on those measures and a robust appellate system.

Student Mobility and Internationalization: Trends and Tribulations

There is no question that internationalization, and particularly international student mobility, has transformed the higher education landscape in the last decade. It has brought diverse benefits to students, institutions, communities and countries. But there are unanticipated outcomes and risks as well. The purpose of this article is look at the complexities and current trends of student mobility and to invite reflection on some of the new developments and unintended consequences. These include granting and recognition of academic credentials; diploma and accreditation mills; collaborative programs such as joint or double degree programs and twinning and franchise arrangements; the great brain race and its implications for brain gain, brain drain, and brain train; the competitiveness agenda; status building and world rankings; regional identity and global citizenship. These macro issues often become an implicit part of the culture or environment of international education without being questioned. Focusing on some worrisome trends and outcomes of new developments in student mobility and internationalization does not deny the multitude of positive results; it is only an attempt to encourage a 360–degree look at the current state of student mobility and to encourage more research and reflection on some important trends and unexpected results.

Parents, partners and peers: bearing the hidden costs of lifelong learning

This paper examines data from three projects to explore the ‘hidden costs’ of participating in lifelong learning. Whilst other potential risks (financial for instance) are anticipated, those around family and friendship ties are usually not. Adult re-engagement with education can result in unexpected negative consequences for learners’ existing relationships, something addressed in academic literature but rarely in official policy rhetoric. We draw upon data from the projects to demonstrate how these unanticipated risks are negotiated and the impact of this discursive practice on those involved. We discuss this sense of risk, and also concepts of entitlement to one aspect of lifelong learning, higher education (HE) amongst those traditionally excluded from it in the UK. Entry to HE alone does not secure either a sense of entitlement, or a reduction of risk in terms of social justice, viewed as a means of fairly redistributing opportunities to compete for credentials. For some non-traditional learners, their sense of a lack of entitlement and levels of loss and risk to identity increase as they participate in university. We conclude by discussing how these ‘hidden costs’ of lifelong learning are borne by learners and those closest to them, their parents, partners and peers, and how institutions may offer support through processes of transition to adult learner.

Risk factors in the development of stem cell therapy

Stem cell therapy holds the promise to treat degenerative diseases, cancer and repair of damaged tissues for which there are currently no or limited therapeutic options. The potential of stem cell therapies has long been recognised and the creation of induced pluripotent stem cells (iPSC) has boosted the stem cell field leading to increasing development and scientific knowledge. Despite the clinical potential of stem cell based medicinal products there are also potential and unanticipated risks. These risks deserve a thorough discussion within the perspective of current scientific knowledge and experience. Evaluation of potential risks should be a prerequisite step before clinical use of stem cell based medicinal products.The risk profile of stem cell based medicinal products depends on many risk factors, which include the type of stem cells, their differentiation status and proliferation capacity, the route of administration, the intended location, in vitro culture and/or other manipulation steps, irreversibility of treatment, need/possibility for concurrent tissue regeneration in case of irreversible tissue loss, and long-term survival of engrafted cells. Together these factors determine the risk profile associated with a stem cell based medicinal product. The identified risks (i.e. risks identified in clinical experience) or potential/theoretical risks (i.e. risks observed in animal studies) include tumour formation, unwanted immune responses and the transmission of adventitious agents.Currently, there is no clinical experience with pluripotent stem cells (i.e. embryonal stem cells and iPSC). Based on their characteristics of unlimited self-renewal and high proliferation rate the risks associated with a product containing these cells (e.g. risk on tumour formation) are considered high, if not perceived to be unacceptable. In contrast, the vast majority of small-sized clinical trials conducted with mesenchymal stem/stromal cells (MSC) in regenerative medicine applications has not reported major health concerns, suggesting that MSC therapies could be relatively safe. However, in some clinical trials serious adverse events have been reported, which emphasizes the need for additional knowledge, particularly with regard to biological mechanisms and long term safety.

Long‐term magnetic resonance imaging of stem cells in neonatal ischemic injury

Quantitative magnetic resonance imaging (MRI) can serially and noninvasively assess the degree of injury in rat pup models of hypoxic ischemic injury (HII). It can also noninvasively monitor stem cell migration following iron oxide prelabeling. Reports have shown that neural stem cells (NSCs) may help mediate neuroprotection or stimulate neuroreparative responses in adult and neonatal models of ischemic injury. We investigated the ability of high-field MRI to monitor and noninvasively quantify the migration, proliferation, and location of iron oxide-labeled NSCs over very long time periods (58 weeks) in real time while contemporaneously correlating this activity with the evolving severity and extent of neural damage. Labeled clonal murine NSCs (mNSCs) were implanted 3 days after unilateral HII in 10-day-old rat pups into the contralateral striatum or ventricle. We developed methods for objectively quantifying key aspects of dynamic NSC behavior (eg, viability; extent, and speed of migration; degree of proliferation; extent of integration into host parenchyma). MRI images were validated with histological and immunohistochemical assessments. mNSCs rapidly migrated (100 μm/day) to the lesion site. Chains of migrating NSCs were observed in the corpus callosum. In pups subjected to HII, though not in intact control animals, we observed a 273% increase in the MR-derived volume of mNSCs 4 weeks after implantation (correlating with the known proliferative behavior of endogenous and exogenous NSCs) that slowly declined over the 58-week time course, with no adverse consequences. Large numbers of now quiescent mNSCs remained at the site of injury, many retaining their iron oxide label. Our studies demonstrate that MRI can simultaneously monitor evolving neonatal cerebral injury as well as NSC migration and location. Most importantly, it can noninvasively monitor proliferation dynamically for prolonged time periods. To be able to pursue clinical trials in newborns using stem cell therapies it is axiomatic that safety be insured through the long-term real time monitoring of cell fate and activity, particularly with regard to observing unanticipated risks to the developing brain. This study supports the feasibility of reliably using MRI for this purpose.

Researching Technoscientific Concerns in the Making: Narrative Structures, Public Responses, and Emerging Nanotechnologies

In this paper I engage with debates on technoscientific governance, narrative, and emergent public attitudes. Building on a piece of social research addressing public responses to the social and ethical dimensions of emerging nanotechnologies, I develop a methodology and mode of analysis designed to take into account four distinctive features of nanotechnology discourse and its constitution in the public sphere, namely: its unfamiliarity; its promissory quality; its uncanniness; and its metaphysical assumptions of progress. Through an analysis of common narratives that shape and structure lay public responses to the technology, and in response to framings of how the technology and its applications are being crafted in the public domain, I argue that nanotechnologies offer a site for an intense future politics centred on dilemmas of body invasion, unanticipated risks, nature's revenge, control, inequalities, and pace of change. I conclude with a set of reflections on the role of the critical social sciences in such a future technopolitics.

Opportunisme ou équité ? Le cas des contrats d’approvisionnement de défense

How are extra costs resulting from the occurrence of unanticipated risks allocated in a procurement setting ? This paper develops a theoretical framework combining transaction cost economics with equity theory in order to explain why parties endorse cooperative strategies, basically a 50-50 sharing rule, that prevail over their propensity to behave opportunistically. We derive two propositions that we test on a dataset of 48 contracts in the French defense procurement. We find that perception of equity turns out to be a key factor in the contractual relationship. This interpretation challenges the prevailing interpretation of a key assumption in transaction cost economics.

Opportunisme ou équité ? Le cas des contrats d'approvisionnement de défense

Résumé Comment sont répartis les surcoûts qui résultent de la matérialisation de risques dans le cadre de relations contractuelles ? Nous proposons une réponse qui combine théorie des coûts de transaction et approche en termes d’équité, de manière à expliquer pourquoi des stratégies coopératives de répartition du type 50-50 prévalent sur la propension des partenaires à se comporter de façon opportuniste. Nous en dérivons deux propositions que nous confrontons à une base de données inédite composée de 48 contrats concernant l’approvisionnement de défense en France. Nous montrons que, sous certaines conditions, la perception d’une allocation équitable se révèle être un facteur clé de la relation contractuelle, ce qui constitue un défi pour l’interprétation habituelle de la théorie des coûts de transaction.

Investing in lay researchers for community-based health action research: implications for research, policy and practice

Calls for greater community participation health-related research are increasingly made and, it seems, heeded–albeit to varying degrees. We report here, from the perspective of external evaluators, on practical efforts by the leaders of two community-based health action research projects to enhance such participation still further by employing a small number of local people as lay action researchers within their own community. ‘Action research’ in this context was conceived as an approach by which comparatively small projects, based on partnerships between academics, communities and public sector organisations, could address local issues of health and well-being. The purpose of the paper is to examine project leaders’ initial assumptions and expectations of the lay action research role and to compare these with the actual experience of those researchers. On this basis we consider the value to organisations and communities of the lay action research role for community health development and point out some of the unanticipated risks such individuals may face. We conclude by highlighting implications for future policy and practice in this area.

Unanticipated risks in morbidly obese patients.

Corresponding author: Young-Cheol Woo, M.D., Ph.D., Department of Anesthesiology and Pain Medicine, Chung-Ang University Hospital, 224-1, Heukseok-dong, Dongjak-gu, Seoul 156-070, Korea. Tel: 82-2-6299-2584, Fax: 82-2-6299-2585, E-mail: wj12@naver.com Copyright c Korean Society of Anesthesiologists, 2009 cc This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In Korea, 32% of adult are obese. Although this rate is based on Asian body mass index (BMI), obese patients have been increasing suddenly and today anesthesiologists can frequently meet morbidly obese patients (MOPs) in the operating rooms. “Morbid obesity” describes obesity that, if untreated, will significantly shorten the patient’s life. The criteria is BMI over 40 kg/m or 100% over ideal body weight. Studies have reported up to a 12-fold excess mortality rate in association with morbid obesity along with an exceptionally high incidence of co-morbidities [1]. In August and October 2009 issues of Korean Journal of Anesthesiology, two case reports warned the risks in MOPs. Kim et al. experienced a respiratory failure and subsequent cardiac arrest after change to supine position in MOP with a BMI of about 62 kg/m [2]. The patient was bearable in lateral position. As position was changed to supine for urologic procedure under local anesthesia in the operating room, he showed dyspnea and agitation. The anesthesiologists were asked for help but cardiopulmonary resuscitation (CPR) was in vain. And they pointed out that there was no CPR guideline for MOPs. Song et al. reported the patient with dyspnea and chest pain after brachial plexus block (BPB) due to phrenic nerve block whose respiratory reserve was decreased [3]. The patient was morbidly obese and general anesthesia was induced because of the unsuccessful BPB and dyspnea. Although she recovered without any residual complication, this case shows that anesthesiologists should have preoperative consideration for decreased respiratory reserves in MOPs. These cases give us a lesson that high vigilance is necessary for management of MOPs. A very small change such as position change and sedatives administration can make patients lethal. Postoperative analgesics given in general ward may cause respiratory failure in MOPs. Because obesity increases risk of multiple organ failure (MOF) after severe trauma [4], multiple fractures in MOPs may cause perioperative death. MOF is more likely to develop within 72 hours of injury in obese patients than non-obese patients and this probably comes from proinflammatory nature of the obese state. Obstructive sleep apnea syndrome (OSAS) is a predominant cause of sudden death in obese persons. Pickwickian syndrome is the most serious OSAS and the patients go as far as to be found dead [5]. One report shows that 15% of severely obese men with OSAS died suddenly and unexpectedly due to acute myocardial infarction and pulmonary edema during a 4-year follow-up. Their mean age was 46 years and mean BMI was 41 kg/m. They did not have other conventional risk factors [6]. MOPs are at risk for various causes of death. And also, perioperative complications may develop suddenly and unexpectedly in MOPs, which may cause legal problems. Therefore prudential approach and high vigilance are essential. However it is not easy to make full evaluation in emergency situation. If anesthesiologists are not familiar with MOPs and there is no treatment guideline including CPR yet, the outcomes will be not good. Nowadays, the anesthesiologists are challenged for management of MOPs and should consider the potential risks for caring for the MOPs.