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The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) was developed more than 25 years ago as an instrument to monitor functional change over time in patients with ALS. It has since been revised and extended to meet the needs of high data quality in ALS trials (ALSFRS-R), however a full re-validation of the scale was not completed. Despite this, the scale has remained a primary outcome measure in clinical trials. We convened a group of clinical trialists to discuss and explore opportunities to improve the scale and propose alternative measures. In this meeting report, we present a call to action on the use of the ALSFRS-Revised scale in clinical trials, focusing on the need for (1) harmonization of the ALSFRS-R administration globally, (2) alignment on a set of recommendations for clinical trial design and statistical analysis plans (SAPs), and (3) use of additional outcome measures. [ABSTRACT FROM AUTHOR]

A study to examine suicide-related events in acute, double-blind, and placebo controlled trials with atomoxetine is conducted. Results conclude that the incidences of suicide were more frequent in children suffering from ADHD treated with atomoxetine as compared to those treated with placebo.

OBJECTIVE -- Inflammation is associated with pancreatic β-cell apoptosis and reduced insulin sensitivity. Literature suggests that interleukin (IL)-1β may contribute to the pathogenesis of type 2 diabetes mellitus (T2DM). This study aimed to determine the efficacy, safety, and tolerability of LY2189102, a neutralizing IL-1β antibody, in T2DM patients. RESEARCH DESIGN AND METHODS -- Phase II, randomized, double-blind, parallel, placebo-controlled study of subcutaneous LY2189102 (0.6, 18, and 180 mg) administered weekly for 12 weeks in T2DM patients on diet and exercise, with or without approved antidiabetic medications. RESULTS -- LY2189102 reduced HbA1c at 12 weeks (adjusted mean differences versus placebo: 20.27, 20.38 and 20.25% for 0.6, 18 and 180 mg doses, respectively), and fasting glucose at multiple time points compared with placebo. LY2189102 also reduced postprandial glycemia, and inflammatory biomarkers, including hs-CRP and IL-6. LY2189102 was generally well tolerated. CONCLUSIONS -- Weekly subcutaneous LY2189102 for 12 weeks was well tolerated, modestly reduced HbA1c and fasting glucose, and demonstrated significant anti-inflammatory effects in T2DM patients. Neutralizing IL-1β holds promise as a convenient adjuvant treatment for T2DM. [ABSTRACT FROM AUTHOR]

Prosecutorial misconduct is not a rare event, but it often goes undetected, unreported, or no action is taken by the criminal justice system. However, when one Texas prosecutor, Ken Anderson, served jail time for wrongfully prosecuting an innocent man, Michael Morton, for murdering his wife, he made history. Anderson withheld exculpatory evidence leading to Morton wrongfully serving 25 years before being released with new DNA evidence. However, Anderson only served a five-day sentence and $500 fine. We discuss the case in the context of inequality and legal realism in the criminal justice system. Also, we look at the implications and new legal action taken by the state of Texas to try and combat this problem, along with looking at these secretive occupational subcultures. [ABSTRACT FROM AUTHOR]

Highlights: [•] We examine of the use of the Alford plea in the West Memphis Three case. [•] The potential of misuse of this plea could become rampant. [•] The legal incentive to use the Alford plea instead of exoneration and compensation should be worrisome. [•] Use of Alford plea by a powerful system could bully the less fortunate in terms of legal wrangling for freedoms and compensation. [ABSTRACT FROM AUTHOR]