Planned adaptation in risk regulation: An initial survey of US environmental, health, and safety regulation

In principle, we want regulatory programs to be based on current realities, as reflected for example in the best knowledge of relevant experts. That would imply that old rules now on the books should be consistent with today's knowledge base, not just what was known when a rule or standard was originally set. This paper reports on a survey of US programs, examining how often existing rules are actually updated in light of better knowledge, and identifies five programs that attempt to make policy routinely adaptive. These programs exhibit what we term Planned Adaptation: they both revise rules when relevant new knowledge appears, and take steps to produce such improved knowledge. While Planned Adaptation is rare, it is used in several nationally prominent programs, including air pollution, airplane safety, and drug safety. Planned Adaptation is a policy tool that deserves more attention

Toward a New Technology and Policy Program (TPP) Curriculum

The mission of the MIT Technology and Policy Program (TPP) is: “Provide an integrative education to scientists and engineers who wish to lead in the development and implementation of responsible strategies and policies for exploitation of technology for the benefit of their communities” (Hastings, 2000). Embedded in the TPP mission statement are several educational requirements: (1) a comprehensive and diverse set of solid analytical skills needed to develop and assess strategies and policies, (2) the flexibility to manage the conflicting interests and values that are present at all stages of the policy process, and (3) the ability to provide leadership at each stage in the policy process. With these concepts in mind, the TPP Curriculum Development Committee will work to place TPP at the forefront of educating the “leaders (researchers and practitioners) of the fields of technology and policy studies” (Hastings, 2000)

The next frontier: Fostering innovation by improving health data access and utilization

Beneath most lively policy debates sit dry-as-dust theoretical and methodological discussions. Current disputes over the EU Adaptive Pathways initiative and the proposed US 21st Century Cures Act may ultimately rest on addressing arcane issues of data curation, standardization, and utilization. Improved extraction of inform ation on the safety and effectiveness of drugs-in-use must parallel adjustments in evidence requirements at the time of licensing. To do otherwise may compromise safety and efficacy in the name of fostering innovation

A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical Trials

We propose an “efficacy-to-effectiveness” (E2E) clinical trial design, in which an effectiveness trial would commence seamlessly upon completion of the efficacy trial. Efficacy trials use inclusion/exclusion criteria to produce relatively homogeneous samples of participants with the target condition, conducted in settings that foster adherence to rigorous clinical protocols. Effectiveness trials use inclusion/exclusion criteria that generate heterogeneous samples that are more similar to the general patient spectrum, conducted in more varied settings, with protocols that approximate typical clinical care. In E2E trials, results from the efficacy trial component would be used to design the effectiveness trial component, to confirm and/or discern associations between clinical characteristics and treatment effects in typical care, and potentially to test new hypotheses. An E2E approach may improve the evidentiary basis for selecting treatments, expand understanding of the effectiveness of treatments in subgroups with particular clinical features, and foster incorporation of effectiveness information into regulatory processes.National Center for Research Resources (U.S.) (Grant UL1 RR025752)National Center for Advancing Translational Sciences (U.S.) (Grant UL1 TR000073

Transatlantic Patterns of Risk Regulation: Implications for International Trade and Cooperation

This report presents a study commissioned by the European Parliament to compare regulatory standards in the EU and the US in four key sectors (food safety, automobiles, chemicals, and pharmaceuticals), chosen for their relevance both to consumer protection and transatlantic trade, and focusing on whether different approaches to risk regulation may lead to different levels of protection. How risks are regulated in the US and the EU can affect domestic outcomes (such as the benefits and costs of protecting consumers, health and environment), and can also foster or limit the opportunities for international trade

Improving Risk Regulation

Confronted with the challenge of improving regulatory performance, many governments in the world are looking for ways to better manage risks, in particular those risks that develop in complex systems, with stakeholders from various sectors, and that are marked by uncertainty. This report includes five authored pieces about: The contribution of transnational private regulation to revisiting risk regulation (Scott), Emerging strategies to manage system-level risks: an examination of private sector, government and non-governmental organization initiative (Yosie), Potential scope and challenges of behaviourally informed regulation (Renn and Florin), and Managing uncertainty in drug development and use, by enhancing adaptability and flexibility in pharmaceuticals regulation (Oye et al.)

Building biosecurity for synthetic biology.

The fast-paced field of synthetic biology is fundamentally changing the global biosecurity framework. Current biosecurity regulations and strategies are based on previous governance paradigms for pathogen-oriented security, recombinant DNA research, and broader concerns related to genetically modified organisms (GMOs). Many scholarly discussions and biosecurity practitioners are therefore concerned that synthetic biology outpaces established biosafety and biosecurity measures to prevent deliberate and malicious or inadvertent and accidental misuse of synthetic biology's processes or products. This commentary proposes three strategies to improve biosecurity: Security must be treated as an investment in the future applicability of the technology; social scientists and policy makers should be engaged early in technology development and forecasting; and coordination among global stakeholders is necessary to ensure acceptable levels of risk

The bi-directional associations between psychotic experiences and DSM-IV mental disorders

OBJECTIVE: While it is now recognized that psychotic experiences are associated with an increased risk of later mental disorders, we lack a detailed understanding of the reciprocal time-lagged relationships between first onsets of psychotic experiences and mental disorders. Using data from World Health Organization World Mental Health (WMH) Surveys, the authors assessed the bidirectional temporal associations between psychotic experiences and mental disorders. METHOD: The WMH Surveys assessed lifetime prevalence and age at onset of psychotic experiences and 21 common DSM-IV mental disorders among 31,261 adult respondents from 18 countries. Discrete-time survival models were used to examine bivariate and multivariate associations between psychotic experiences and mental disorders. RESULTS: Temporally primary psychotic experiences were significantly associated with subsequent first onset of eight of the 21 mental disorders (major depressive disorder, bipolar disorder, generalized anxiety disorder, social phobia, posttraumatic stress disorder, adult separation anxiety disorder, bulimia nervosa, and alcohol abuse), with odds ratios ranging from 1.3 (95% CI=1.2-1.5) for major depressive disorder to 2.0 (95% CI=1.5-2.6) for bipolar disorder. In contrast, 18 of 21 primary mental disorders were significantly associated with subsequent first onset of psychotic experiences, with odds ratios ranging from 1.5 (95% CI=1.0-2.1) for childhood separation anxiety disorder to 2.8 (95% CI=1.0-7.8) for anorexia nervosa. CONCLUSIONS: While temporally primary psychotic experiences are associated with an elevated risk of several subsequent mental disorders, these data show that most mental disorders are associated with an elevated risk of subsequent psychotic experiences. Further investigation of the underlying factors accounting for these time-order relationships may shed light on the etiology of psychotic experiences

findings from the World Health Organization World Mental Health surveys

Funding Information: The World Health Organization World Mental Health (WMH) Survey Initiative is supported by the United States National Institute of Mental Health (NIMH; R01 MH070884), the John D. and Catherine T. MacArthur Foundation, the Pfizer Foundation, the United States Public Health Service (R13-MH066849, R01-MH069864 and R01 DA016558), the Fogarty International Center (FIRCA R03-TW006481), the Pan American Health Organization, Eli Lilly and Company, Ortho-McNeil Pharmaceutical Inc., GlaxoSmithKline and Bristol-Myers Squibb. We thank the staff of the WMH Data Collection and Data Analysis Coordination Centres for assistance with instrumentation, fieldwork and consultation on data analysis. The Argentina survey—Estudio Argentino de Epidemiología en Salud Mental (EASM)— was supported by a grant from the Argentinian Ministry of Health (Ministerio de Salud de la Nación). The São Paulo Megacity Mental Health Survey is supported by the State of São Paulo Research Foundation (FAPESP) Thematic Project Grant 03/00204–3. The Colombian National Study of Mental Health (NSMH) is supported by the Ministry of Social Protection. The ESEMeD surveys were funded by the European Commission (contracts QLG5–1999-01042; SANCO 2004123 and EAHC 20081308), the Piedmont Region, Italy, Fondo de Investigación Sanitaria, Instituto de Salud Carlos III, Spain (FIS 00/0028), Ministerio de Ciencia y Tecnología, Spain (SAF 2000– 158-CE), Departament de Salut, Generalitat de Catalunya, Spain, Instituto de Salud Carlos III (CIBER CB06/02/0046, RETICS RD06/0011 REM-TAP) and other local agencies and by an unrestricted educational grant from GlaxoSmithKline. Implementation of the Iraq Mental Health Survey (IMHS) and data entry were carried out by the staff of the Iraqi MOH and MOP with direct support from the Iraqi IMHS team with funding from both the Japanese and European Funds through the United Nations Development Group Iraq Trust Fund (UNDG ITF). The Lebanese Evaluation of the Burden of Ailments and Needs of the Nation (L.E.B.A.N.O.N.) is supported by the Lebanese Ministry of Public Health, the WHO (Lebanon), National Institute of Health/Fogarty International Center (R03 TW006481–01), anonymous private donations to IDRAAC, Lebanon and unrestricted grants from, Algorithm, AstraZeneca, Benta, Bella Pharma, Eli Lilly, Glaxo Smith Kline, Lundbeck, Novartis, OmniPharma, Pfizer, Phenicia, Servier, UPO. The Mexican National Comorbidity Survey (MNCS) is supported by The National Institute of Psychiatry Ramon de la Fuente (INPRFMDIES 4280) and by the National Council on Science and Technology (CONACyT-G30544-H), with supplemental support from the PanAmerican Health Organization (PAHO). Te Rau Hinengaro: the New Zealand Mental Health Survey (NZMHS) is supported by the New Zealand Ministry of Health, Alcohol Advisory Council and the Health Research Council. The Nigerian Survey of Mental Health and Wellbeing (NSMHW) is supported by the WHO (Geneva), the WHO (Nigeria) and the Federal Ministry of Health, Abuja, Nigeria. The Peruvian World Mental Health Study was funded by the National Institute of Health of the Ministry of Health of Peru. The Portuguese Mental Health Study was carried out by the Department of Mental Health, Faculty of Medical Sciences, NOVA University of Lisbon, with collaboration of the Portuguese Catholic University, and was funded by Champalimaud Foundation, Gulbenkian Foundation, Foundation for Science and Technology (FCT) and Ministry of Health. The Romania WMH study projects ‘Policies in Mental Health Area’ and ‘National Study regarding Mental Health and Services Use’ were carried out by the National School of Public Health and Health Services Management (former National Institute for Research and Development in Health, present National School of Public Health Management and Professional Development, Bucharest), with technical support of Metro Media Transilvania, the National Institute of Statistics—National Centre for Training in Statistics, SC. Cheyenne Services SRL, Statistics Netherlands and were funded by the Ministry of Public Health (former Ministry of Health) with supplemental support of Eli Lilly Romania SRL. The US National Comorbidity Survey Replication (NCS-R) is supported by the National Institute of Mental Health (NIMH; U01-MH60220) with supplemental support from the National Institute of Drug Abuse (NIDA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Robert Wood Johnson Foundation (RWJF; grant 044708) and the John W. Alden Trust. None of the funders had any role in the design, analysis, interpretation of results or preparation of this paper. The views and opinions expressed in this report are those of the authors and should not be construed to represent the views of the World Health Organization, other sponsoring organizations, agencies or governments. J.J.M. received the John Cade Fellowship APP1056929 from the National Health and Medical Research Council and the Niels Bohr Professorship from the Danish National Research Foundation. A complete list of all within-country and cross-national WMH publications can be found at http://www.hcp.med. harvard.edu/wmh/. Publisher Copyright: © 2017 Society for the Study of AddictionBackground and aims: Prior research has found bidirectional associations between psychotic experiences (PEs) and selected substance use disorders. We aimed to extend this research by examining the bidirectional association between PEs and various types of substance use (SU) and substance use disorders (SUDs), and the influence of antecedent mental disorders on these associations. Design, setting, participants and measurements: We used data from the World Health Organization World Mental Health surveys. A total of 30 902 adult respondents across 18 countries were assessed for (a) six types of life-time PEs, (b) a range of types of SU and DSM-IV SUDs and (c) mental disorders using the Composite International Diagnostic Interview. Discrete-time survival analyses based on retrospective age-at-onset reports examined the bidirectional associations between PEs and SU/SUDs controlling for antecedent mental disorders. Findings: After adjusting for demographics, comorbid SU/SUDs and antecedent mental disorders, those with prior alcohol use disorders [odds ratio (OR) = 1.6, 95% confidence interval (CI) = 1.2–2.0], extra-medical prescription drug use (OR = 1.5, 95% CI = 1.1–1.9), alcohol use (OR = 1.4, 95% CI = 1.1–1.7) and tobacco use (OR = 1.3, 95% CI = 1.0–1.8) had increased odds of subsequent first onset of PEs. In contrast, those with temporally prior PEs had increased odds of subsequent onset of tobacco use (OR = 1.5, 95% CI = 1.2–1.9), alcohol use (OR = 1.3, 95% CI = 1.1–1.6) or cannabis use (OR = 1.3, 95% CI = 1.0–1.5) as well as of all substance use disorders (ORs ranged between 1.4 and 1.5). There was a dose response relationship between both count and frequency of PEs and increased subsequent odds of selected SU/SUDs. Conclusions: Associations between psychotic experiences (PEs) and substance use/substance use disorders (SU/SUDs) are often bidirectional, but not all types of SU/SUDs are associated with PEs. These findings suggest that it is important to be aware of the presence of PEs within those with SUDs or at risk of SUDs, given the plausibility that they may each impact upon the other.publishersversionpublishe