Supreme Court Amicus Brief Regarding Wyeth v. Diana Levine

Prominent in arguments opposing preemption of state tort law liability for alleged inadequacies in prescription drug labeling is the argument that such liability can complement FDA regulation by improving on a regulatory scheme that fails to provide adequate deterrence against the marketing of unsafe or inadequately labeled drugs. The premise of this argument is faulty. Fundamental principles of economics and numerous studies of FDA drug regulation reveal that FDA in fact errs on the side of overregulation of prescription drugs. Product liability litigation focused solely on one side of the prescription drug public health equation leads to further distortions of the drug approval and labeling process and exacerbates FDA's inherent overly cautious approach. Preemption of state tort law where it conflicts with FDA requirements will minimize these distortions and thereby maximize public health.Health and Safety, Other Topics

Postural stability in older adults with a distal radial fracture

BACKGROUND: The physical risk factors leading to distal radial fractures are poorly understood. The goal of this study was to compare postural stability between older adults with and without a prior distal radial fragility fracture. METHODS: This case-control evaluation was performed at a single tertiary institution. The fracture cohort comprised 23 patients treated for a low-energy distal radial fracture within 6 to 24 months prior to this study. Twenty-three age and sex-matched control participants, without a prior fragility fracture, were selected from an outpatient clinic population. All participants completed a balance assessment with a computerized balance platform device. Dynamic motion analysis (DMA) scores ranging from 0 to 1,440 points are produced, with lower scores indicating better postural stability. Participants also completed validated questionnaires for general health quality (EuroQol-5D-3L [EQ-5D-3L]) and physical activity (Physical Activity Scale for the Elderly [PASE]) and comprehensive health and demographic information including treatment for compromised balance or osteoporosis. Statistical analysis compared data between cases and controls using either the Student t test or the Mann-Whitney U test. RESULTS: There were no significant differences (p > 0.05) in age, sex, body mass index, physical activity score, or EQ-5D-3L general health visual analog scale score between participants with or without prior distal radial fracture. The fracture cohort demonstrated poorer balance, with higher DMA scores at 933 points compared with 790 points for the control cohort (p = 0.008). Nineteen patients (83%) in the fracture cohort reported having dual x-ray absorptiometry (DXA) scans within 5 years prior to this study, but only 2 patients (9%) had ever been referred for balance training with physical therapy. CONCLUSIONS: Older adults who sustain low-energy distal radial fractures demonstrate impaired postural stability compared with individuals of a similar age who have not sustained such fractures. Following a distal radial fracture, these patients may benefit from interventions to improve postural stability. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence

Vitamin D deficiency contributes directly to the acute respiratory distress syndrome (ARDS)

Rationale: Vitamin D deficiency has been implicated as a pathogenic factor in sepsis and intensive therapy unit mortality but has not been assessed as a risk factor for acute respiratory distress syndrome (ARDS). Causality of these associations has never been demonstrated. Objectives: To determine if ARDS is associated with vitamin D deficiency in a clinical setting and to determine if vitamin D deficiency in experimental models of ARDS influences its severity. Methods: Human, murine and in vitro primary alveolar epithelial cell work were included in this study. Findings: Vitamin D deficiency (plasma 25(OH)D levels 600 genes. In a clinical setting, pharmacological repletion of vitamin D prior to oesophagectomy reduced the observed changes of in vivo measurements of alveolar capillary damage seen in deficient patients. Conclusions: Vitamin D deficiency is common in people who develop ARDS. This deficiency of vitamin D appears to contribute to the development of the condition, and approaches to correct vitamin D deficiency in patients at risk of ARDS should be developed

Consumer Response to Drug Risk Information:The Role of Positive Affect

Risk disclosure is an essential element of the marketing of prescription drugs and other medical products. This study examines how consumers respond to verbal information about the frequency and severity of medical-product risks and how media-induced affect can moderate such responses. The study finds that consumers tend to overestimate the actual likelihood of adverse events described with words such as “common” or “rare” (compared with the probabilities such terms are typically intended to convey) and that consumers tend to give little weight to such probability language when forming product use intentions. However, consumers in positive media-induced moods seem to engage in more nuanced evaluation of product risk information, weighing both frequency and severity information and using such information to make inferences about other product attributes (e.g., product efficacy). These findings suggest that medical marketers and regulators need to devise more effective means of communicating risk probability to consumers and that positive mood induction (e.g., by placing advertisements in upbeat media environments) can enhance consumers' ability to process product risk information

Subphenotypes of Acute Respiratory Distress Syndrome: Advancing Towards Precision Medicine

Acute respiratory distress syndrome (ARDS) is a common cause of severe hypoxemia defined by the acute onset of bilateral non-cardiogenic pulmonary edema. The diagnosis is made by defined consensus criteria. Supportive care, including prevention of further injury to the lungs, is the only treatment that conclusively improves outcomes. The inability to find more advanced therapies is due, in part, to the highly sensitive but relatively non-specific current syndromic consensus criteria, combining a heterogenous population of patients under the umbrella of ARDS. With few effective therapies, the morality rate remains 30% to 40%. Many subphenotypes of ARDS have been proposed to cluster patients with shared combinations of observable or measurable traits. Subphenotyping patients is a strategy to overcome heterogeneity to advance clinical research and eventually identify treatable traits. Subphenotypes of ARDS have been proposed based on radiographic patterns, protein biomarkers, transcriptomics, and/or machine-based clustering of clinical and biological variables. Some of these strategies have been reproducible across patient cohorts, but at present all have practical limitations to their implementation. Furthermore, there is no agreement on which strategy is the most appropriate. This review will discuss the current strategies for subphenotyping patients with ARDS, including the strengths and limitations, and the future directions of ARDS subphenotyping