Five-Hundred Life-Saving Interventions and Their Misuse in the Debate over Regulatory Reform

The author argues that John D. Graham, administrator of the Office of Information and Regulatory Affairs, holds strong anti-environmental biases and has perpetuated and encouraged a misrepresentation of his own research, which has largely influenced health, safety, and environmental regulation

What\u27s the Risk in Risk?

Risk vs. Risk: Tradeoffs in Protecting Health and the Environment, John D. Graham and Jonathan Baert Wiener eds., Cambridge: Harvard University Press, 1995. 337 pages. Risk has become a four-letter word in much of the environmental community. Carol Browner, the Clinton Administration\u27s Environmental Protection Agency (EPA) Administrator recently deleted risk from the list of the EPA\u27s Guiding Principles, reportedly at the behest of environmental group leaders.This action, reversing the focus of prior administrations on risk-based priority setting, reflected the perception among environmentalists that making risk analysis a centerpiece of EPA\u27s work inhibits regulatory activity and hampers environmental protection

Kristin S. Seefeldt and John D. Graham, America’s Poor and the Great Recession

In this concise yet highly informative study, Kristin Seefeldt and John Graham examine the multiple ways in which the Great Recession of the period from December 2007 to June 2009 and its aftermath affected the lives of low-income Americans. Appropriately enough, the authors set out to explain the terms in which poverty is defined in contemporary U.S. before they can first consider the efficacy of federal anti-poverty programs and then conclude the work with their own suggestions on how the g..

Only a Poor Workman Blames His Tools: On Uses and Abuses of Benefit-Cost Analysis in Regulatory Decision Making About the Environment

In response to John D. Graham, Saving Lives Through Administrative Law and Economics, 157 U. PA. L. Rev. 395 (2008). The debate that has raged in the legal literature for the last decade about benefit-cost analysis (BCA) in regulatory decision making about the environment has not been very productive for two key reasons: (1) it has focused on the way that BCA is used in the OIRA review process to fine tune regulations just before they are issued, and (2) it has suffered from selective realism - by discussing the flaws of BCA but not comparing them to the flaws of human decision making unaided by BCA. John Graham\u27s 146 page, fiull-throated defense of BCA brings much needed balance to this debate by answering the critics. His article is particularly useful for making accessible to lawyers and law students the ethical and philosophical underpinnings of BCA, and also for demonstrating by example that BCA is not inherently antiregulatory and can be useful for convincing skeptical politicians to sign off on tough environmental regulations. But, unfortunately, Graham\u27s article implicitly buys into the two conceptual traps that it inherits from the critics: both the fine tuning and the selective realism fallacies

Regleprudence – at OIRA and Beyond

There are significant domains of legality within the administrative state that are mostly immune from judicial review and have mostly escaped the attention of legal theorists. While administrative law generally focuses on the products of agency action as they are reviewed by the judiciary, there are important aspects of regulatory activity that are legal or law-like but rarely interrogated by systematic analysis with reference to accounts about the role and nature of law. In this Article, we introduce a category of analysis we call regleprudence, a sibling of jurisprudence and legisprudence. Once we explore some regleprudential norms, we delve into one case study – the Office of Information and Regulatory Affairs and the legal work it undertakes through regulatory review – and gesture at how more general attention to regleprudence can improve our understanding of important corners of the Executive Branch

Regleprudence – at OIRA and Beyond

There are significant domains of legality within the administrative state that are mostly immune from judicial review and have mostly escaped the attention of legal theorists. While administrative law generally focuses on the products of agency action as they are reviewed by the judiciary, there are important aspects of regulatory activity that are legal or law-like but rarely interrogated by systematic analysis with reference to accounts about the role and nature of law. In this Article, we introduce a category of analysis we call regleprudence, a sibling of jurisprudence and legisprudence. Once we explore some regleprudential norms, we delve into one case study – the Office of Information and Regulatory Affairs and the legal work it undertakes through regulatory review – and gesture at how more general attention to regleprudence can improve our understanding of important corners of the Executive Branch

Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Survival results from an adaptive, multiarm, multistage, platform randomised controlled trial

BACKGROUND Long-term hormone therapy has been the standard of care for advanced prostate cancer since the 1940s. STAMPEDE is a randomised controlled trial using a multiarm, multistage platform design. It recruits men with high-risk, locally advanced, metastatic or recurrent prostate cancer who are starting first-line long-term hormone therapy. We report primary survival results for three research comparisons testing the addition of zoledronic acid, docetaxel, or their combination to standard of care versus standard of care alone. METHODS Standard of care was hormone therapy for at least 2 years; radiotherapy was encouraged for men with N0M0 disease to November, 2011, then mandated; radiotherapy was optional for men with node-positive non-metastatic (N+M0) disease. Stratified randomisation (via minimisation) allocated men 2:1:1:1 to standard of care only (SOC-only; control), standard of care plus zoledronic acid (SOC + ZA), standard of care plus docetaxel (SOC + Doc), or standard of care with both zoledronic acid and docetaxel (SOC + ZA + Doc). Zoledronic acid (4 mg) was given for six 3-weekly cycles, then 4-weekly until 2 years, and docetaxel (75 mg/m(2)) for six 3-weekly cycles with prednisolone 10 mg daily. There was no blinding to treatment allocation. The primary outcome measure was overall survival. Pairwise comparisons of research versus control had 90% power at 2·5% one-sided α for hazard ratio (HR) 0·75, requiring roughly 400 control arm deaths. Statistical analyses were undertaken with standard log-rank-type methods for time-to-event data, with hazard ratios (HRs) and 95% CIs derived from adjusted Cox models. This trial is registered at ClinicalTrials.gov (NCT00268476) and ControlledTrials.com (ISRCTN78818544). FINDINGS 2962 men were randomly assigned to four groups between Oct 5, 2005, and March 31, 2013. Median age was 65 years (IQR 60-71). 1817 (61%) men had M+ disease, 448 (15%) had N+/X M0, and 697 (24%) had N0M0. 165 (6%) men were previously treated with local therapy, and median prostate-specific antigen was 65 ng/mL (IQR 23-184). Median follow-up was 43 months (IQR 30-60). There were 415 deaths in the control group (347 [84%] prostate cancer). Median overall survival was 71 months (IQR 32 to not reached) for SOC-only, not reached (32 to not reached) for SOC + ZA (HR 0·94, 95% CI 0·79-1·11; p=0·450), 81 months (41 to not reached) for SOC + Doc (0·78, 0·66-0·93; p=0·006), and 76 months (39 to not reached) for SOC + ZA + Doc (0·82, 0·69-0·97; p=0·022). There was no evidence of heterogeneity in treatment effect (for any of the treatments) across prespecified subsets. Grade 3-5 adverse events were reported for 399 (32%) patients receiving SOC, 197 (32%) receiving SOC + ZA, 288 (52%) receiving SOC + Doc, and 269 (52%) receiving SOC + ZA + Doc. INTERPRETATION Zoledronic acid showed no evidence of survival improvement and should not be part of standard of care for this population. Docetaxel chemotherapy, given at the time of long-term hormone therapy initiation, showed evidence of improved survival accompanied by an increase in adverse events. Docetaxel treatment should become part of standard of care for adequately fit men commencing long-term hormone therapy. FUNDING Cancer Research UK, Medical Research Council, Novartis, Sanofi-Aventis, Pfizer, Janssen, Astellas, NIHR Clinical Research Network, Swiss Group for Clinical Cancer Research

A Survey of Residual Cancer Risks Permitted by Health, Safety and Environmental Policy

The authors describe permitted U.S. residual cancer risks, focusing on numerical levels specifically and implicitly authorized by statute or regulation. They also discuss potential changes