Regulatory Improvement Legislation: Risk Assessment, Cost-Benefit Analysis, and Judicial Review

As the number, cost, and complexity of federal regulations have grown over the past twenty years, there has been growing interest in the use of analytic tools such as risk assessment and cost-benefit analysis to improve the regulatory process. The application of these tools to public health, safety, and environmental problems has become commonplace in the peer-reviewed scientific and medical literatures. Recent studies prepared by Resources for the Future, the American Enterprise Institute, the Brookings Institution, and the Harvard Center for Risk Analysis have demonstrated how formal analyses can and often do help government agencies achieve more protection against hazards at less cost than would otherwise occur. Although analytic tools hold great promise, their use by federal agencies is neither consistent nor rigorous. The 103rd, 104th, 105th and 106th Congresses demonstrated sustained interest in the passage of comprehensive legislation governing the employment of these tools in the federal regulatory process. While legislative proposals on this issue have attracted significant bipartisan interest, and recent amendments to particular enabling statutes have incorporated some of these analytical requirements, no comprehensive legislation has been enacted into law since passage of the Administrative Procedure Act in 1946. The inability to pass such legislation has been attributed to a variety of factors, but a common substantive concern has been uncertainty and controversy about how such legislation should address judicial review issues. For example, the judicial review portion of The Regulatory Improvement Act (S. 981), the 105th Congress\u27s major legislative initiative, was criticized simultaneously as meaningless (for allegedly offering too few opportunities for petitioners to challenge poorly reasoned agency rules) and dangerous (as supposedly enabling petitioners to paralyze even well-reasoned agency rules). Thus, a significant obstacle to regulatory improvement legislation appears to be the conflicting opinions among legal scholars and practitioners about how judicial review issues should be addressed in such legislation. The Clinton Administration and the authors of S. 981 believe they have crafted a workable compromise, one that accommodates the need to bring more rigor and transparency to an agency\u27s decisional processes without imposing excessive judicial review. Nevertheless, it is clear that their agreement on this subject, if included in future legislative deliberations, will be scrutinized and contested. Recognizing the importance of the judicial review issue to this and, indeed, any effort to improve the regulatory process, the Center for Risk Analysis at the Harvard School of Public Health convened an invitational Workshop of accomplished legal practitioners and scholars to discuss how judicial review should be handled in legislation of this kind. The full-day Workshop was conducted in Washington, D.C. on December 17, 1998. Its purpose was to discuss principles, experiences, and insights that might inform future public debate about how judicial review should be addressed in legislative proposals that entail use of risk assessment and/or cost-benefit analysis in agency decision-making (whether the proposals are comprehensive or agency-specific). In order to provide the Workshop a practical focus, participants analyzed the provisions of S. 981 (as modified at the request of the Clinton Administration). An exchange of letters between S. 981\u27s chief sponsors and the Clinton Administration defining the terms of the agreement was examined as well. This Report highlights the themes of the Workshop discussion and offers some specific commentary on how proposed legislation (including but not limited to S. 981) could be improved in future legislative deliberations

Regulatory Improvement Legislation: Risk Assessment, Cost-Benefit Analysis, and Judicial Review

As the number, cost, and complexity of federal regulations have grown over the past twenty years, there has been growing interest in the use of analytic tools such as risk assessment and cost-benefit analysis to improve the regulatory process. The application of these tools to public health, safety, and environmental problems has become commonplace in the peer-reviewed scientific and medical literatures. Recent studies prepared by Resources for the Future, the American Enterprise Institute, the Brookings Institution, and the Harvard Center for Risk Analysis have demonstrated how formal analyses can and often do help government agencies achieve more protection against hazards at less cost than would otherwise occur. Although analytic tools hold great promise, their use by federal agencies is neither consistent nor rigorous. The 103rd, 104th, 105th and 106th Congresses demonstrated sustained interest in the passage of comprehensive legislation governing the employment of these tools in the federal regulatory process. While legislative proposals on this issue have attracted significant bipartisan interest, and recent amendments to particular enabling statutes have incorporated some of these analytical requirements, no comprehensive legislation has been enacted into law since passage of the Administrative Procedure Act in 1946. The inability to pass such legislation has been attributed to a variety of factors, but a common substantive concern has been uncertainty and controversy about how such legislation should address judicial review issues. For example, the judicial review portion of The Regulatory Improvement Act (S. 981), the 105th Congress\u27s major legislative initiative, was criticized simultaneously as meaningless (for allegedly offering too few opportunities for petitioners to challenge poorly reasoned agency rules) and dangerous (as supposedly enabling petitioners to paralyze even well-reasoned agency rules). Thus, a significant obstacle to regulatory improvement legislation appears to be the conflicting opinions among legal scholars and practitioners about how judicial review issues should be addressed in such legislation. The Clinton Administration and the authors of S. 981 believe they have crafted a workable compromise, one that accommodates the need to bring more rigor and transparency to an agency\u27s decisional processes without imposing excessive judicial review. Nevertheless, it is clear that their agreement on this subject, if included in future legislative deliberations, will be scrutinized and contested. Recognizing the importance of the judicial review issue to this and, indeed, any effort to improve the regulatory process, the Center for Risk Analysis at the Harvard School of Public Health convened an invitational Workshop of accomplished legal practitioners and scholars to discuss how judicial review should be handled in legislation of this kind. The full-day Workshop was conducted in Washington, D.C. on December 17, 1998. Its purpose was to discuss principles, experiences, and insights that might inform future public debate about how judicial review should be addressed in legislative proposals that entail use of risk assessment and/or cost-benefit analysis in agency decision-making (whether the proposals are comprehensive or agency-specific). In order to provide the Workshop a practical focus, participants analyzed the provisions of S. 981 (as modified at the request of the Clinton Administration). An exchange of letters between S. 981\u27s chief sponsors and the Clinton Administration defining the terms of the agreement was examined as well. This Report highlights the themes of the Workshop discussion and offers some specific commentary on how proposed legislation (including but not limited to S. 981) could be improved in future legislative deliberations

Brief psychosocial education, not core stabilization, reduced incidence of low back pain: results from the Prevention of Low Back Pain in the Military (POLM) cluster randomized trial

<p>Abstract</p> <p>Background</p> <p>Effective strategies for the primary prevention of low back pain (LBP) remain elusive with few large-scale clinical trials investigating exercise and education approaches. The purpose of this trial was to determine whether core stabilization alone or in combination with psychosocial education prevented incidence of low back pain in comparison to traditional lumbar exercise.</p> <p>Methods</p> <p>The Prevention of Low Back Pain in the Military study was a cluster randomized clinical study with four intervention arms and a two-year follow-up. Participants were recruited from a military training setting from 2007 to 2008. Soldiers in 20 consecutive companies were considered for eligibility (n = 7,616). Of those, 1,741 were ineligible and 1,550 were eligible but refused participation. For the 4,325 Soldiers enrolled with no previous history of LBP average age was 22.0 years (SD = 4.2) and there were 3,082 males (71.3%). Companies were randomly assigned to receive traditional lumbar exercise, traditional lumbar exercise with psychosocial education, core stabilization exercise, or core stabilization with psychosocial education, The psychosocial education session occurred during one session and the exercise programs were done daily for 5 minutes over 12 weeks. The primary outcome for this trial was incidence of low back pain resulting in the seeking of health care.</p> <p>Results</p> <p>There were no adverse events reported. Evaluable patient analysis (4,147/4,325 provided data) indicated no differences in low back incidence resulting in the seeking of health care between those receiving the traditional exercise and core stabilization exercise programs. However, brief psychosocial education prevented low back pain episodes regardless of the assigned exercise approach, resulting in a 3.3% (95% CI: 1.1 to 5.5%) decrease over two years (numbers needed to treat (NNT) = 30.3, 95% CI = 18.2 to 90.9).</p> <p>Conclusions</p> <p>Core stabilization has been advocated as preventative, but offered no such benefit when compared to traditional lumbar exercise in this trial. Instead, a brief psychosocial education program that reduced fear and threat of low back pain decreased incidence of low back pain resulting in the seeking of health care. Since this trial was conducted in a military setting, future studies are necessary to determine if these findings can be translated into civilian populations.</p> <p>Trial Registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT00373009">NCT00373009</a> at ClinicalTrials.gov - <url>http://clinicaltrials.gov/</url></p

Genome-wide meta-analysis of 158,000 individuals of European ancestry identifies three loci associated with chronic back pain

Back pain is the #1 cause of years lived with disability worldwide, yet surprisingly little is known regarding the biology underlying this symptom. We conducted a genome-wide association study (GWAS) meta-analysis of ch

Vaccine-associated enhanced respiratory pathology in COVID-19 hamsters after T(H)2-biased immunization

Vaccine-associated enhanced respiratory disease (VAERD) is a severe complication for some respiratory infections. To investigate the potential for VAERD induction in coronavirus disease 2019 (COVID-19), we evaluate two vaccine leads utilizing a severe hamster infection model: a T helper type 1 (T(H)1)-biased measles vaccine-derived candidate and a T(H)2-biased alum-adjuvanted, non-stabilized spike protein. The measles virus (MeV)-derived vaccine protects the animals, but the protein lead induces VAERD, which can be alleviated by dexamethasone treatment. Bulk transcriptomic analysis reveals that our protein vaccine prepares enhanced host gene dysregulation in the lung, exclusively up-regulating mRNAs encoding the eosinophil attractant CCL-11, T(H)2-driving interleukin (IL)-19, or T(H)2 cytokines IL-4, IL-5, and IL-13. Single-cell RNA sequencing (scRNA-seq) identifies lung macrophages or lymphoid cells as sources, respectively. Our findings imply that VAERD is caused by the concerted action of hyperstimulated macrophages and T(H)2 cytokine-secreting lymphoid cells and potentially links VAERD to antibody-dependent enhancement (ADE). In summary, we identify the cytokine drivers and cellular contributors that mediate VAERD after T(H)2-biased vaccination

Comparative study of the biological behaviour in hamster of two isolates of leishmania characterized respectively as L. major-like and L. donovani

Hamster inoculated intraperitoneally with 1 x 10(7) parasites of L. donovani and L. major-like of the New World were studied in groups of 15, 30, 60 and 90 days of infection. The parasite load and density showed progressive increase with the evolution of the infection and was higher in the L. donovani groups than in the L. major-like groups. The L. major-like groups showed parasite density higher in the spleen than in the liver and was similar in both organs in L. donovani groups. The histopathology showed a diffuse marked hyperplasia and hypertrophy of the reticuloendothelial system with high parasitism in the L. donovani groups while there was focal involvement of these organs in L. major-like groups, forming nodules of macrophages that were scantly parasitised. The biological behaviour could be useful in the preliminary studies of Leishmania strain in regional laboratories and understanding the histopathology of lesions caused by different leishmania species

A neurophysiological interpretation of the respiratory act

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/47945/1/10254_2005_Article_BF02320667.pd