• Canada finally opens up data on new drugs and devices: Other regulators should take note of Health Canada’s substantive reforms

  Doshi, Peter (BMJ Publishing Group, 2019-04-17)
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  The assessment of resistance to antidepressant treatment: Rationale for the Antidepressant Treatment History Form: Short Form (ATHF-SF)

  Sackeim, H. (Elsevier Inc., 2019-03-21)

  There is considerable diversity in how treatment-resistant depression (TRD) is defined. However, every definition incorporates the concept that patients with TRD have not benefited sufficiently from one or more adequate trials of antidepressant treatment. This review examines the issues fundamental to the systematic evaluation of antidepressant treatment adequacy and resistance. These issues include the domains of interventions deemed effective in treatment of major depressive episodes (e.g., pharmacotherapy, brain stimulation, and psychotherapy), the subgroups of patients for whom distinct adequacy criteria are needed (e.g., bipolar vs. unipolar depression, psychotic vs. nonpsychotic depression), whether trials should be rated dichotomously as adequate or inadequate or on a potency continuum, whether combination and augmentation strategies require specific consideration, and the criteria used to evaluate the adequacy of treatment delivery (e.g., dose, duration), trial adherence, and clinical outcome. This review also presents the Antidepressant Treatment History Form: Short-Form (ATHF-SF), a completely revised version of an earlier instrument, and details how these fundamental issues were addressed in the ATHF-SF. © 2019 The Authors
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  Factors affecting interpretation of national biomonitoring data from multiple countries: BPA as a case study

  LaKind, J. (Elsevier Inc., 2019-03-19)

  Introduction: The use of biomonitoring data as an indicator of national levels of human exposure to environmental chemicals has grown in importance and prevalence. Nationally representative urinary bisphenol A (BPA) data are now available for Canada, the United States and Korea. Here we address the following questions: Are urinary BPA data from these countries comparable? What can be discerned regarding geographic and/or temporal similarities or differences? Are there generalizable lessons to be learned regarding comparison of biomonitoring results from different countries? Methods: We examined underlying methods and resultant urinary BPA data from national surveys of three countries: Canada (Canadian Health Measures Survey, CHMS, 2009-2015); United States (National Health and Nutrition Examination Survey, NHANES, 2009–2014); and Korea (Korean National Environmental Health Survey, KoNEHS, 2009–2014). We estimated BPA daily intakes on both a volume- and creatinine-adjusted basis. Results: The three countries use similar methods for analyzing urine samples for BPA and participate in external proficiency testing with acceptable results. Field blanks are only used in the CHMS program. There were program-specific differences in fasting times of participants. Median urinary BPA levels in Canada remained relatively constant over the three cycles (1.1–1.2 ng/ml), while US levels decreased (from 1.9 to 1.3 ng/ml) and Korean levels increased (from 0.7 to 1.1 ng/ml) over similar time periods. The most recent survey year data indicate that levels do not differ substantially across countries. Canadian urinary BPA levels have been stable; the subtle, non-significant decrease in intakes may be due to higher body weight in the more recent Canadian surveys. In contrast, the decrease in intakes in the US appears to be due to decreases in urinary BPA as body weights in the US have been stable. Estimated 95th percentile intakes are over an order of magnitude below current health-based guidance values. Discussion: Our assessment of urinary BPA data from Canada, the US and Korea indicates that methodological differences, methods for dilution adjustment, and population characteristics should be carefully considered when interpreting biomonitoring data. Despite the plethora of publications describing issues with use of creatinine levels for urinary dilution adjustment, there have been no major methodological advances that would assist in interpreting urinary chemical data. A combination of biomonitoring and traditional exposure assessment approaches may be needed to fully assess human exposures to BPA and other chemicals. Conclusions: National biomonitoring surveys provide important information on population levels of chemicals such as BPA and can assist in understanding temporal and geographic similarities, differences, and trends. However, caution must be exercised when using these data to draw anything but broad conclusions, due to both intercountry methodological differences and factors affecting urinary chemical levels that are still poorly understood. While the issues raised in this paper do not appear to be a major concern specifically for the national-scale monitoring of BPA described here, they must be considered when comparing data for other chemicals measured as part of both national and smaller-scale biomonitoring-based research as well as for BPA data from other studies. © 2019
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  Chronic pain after blast-induced traumatic brain injury in awake rats

  Uddin, O. (Elsevier Inc., 2019-04-01)

  Explosive blast-induced traumatic brain injury (blast-TBI) in military personnel is a leading cause of injury and persistent neurological abnormalities, including chronic pain. We previously demonstrated that chronic pain after spinal cord injury results from central sensitization in the posterior thalamus (PO). The presence of persistent headaches and back pain in veterans with blast-TBI suggests a similar involvement of thalamic sensitization. Here, we tested the hypothesis that pain after blast-TBI is associated with abnormal increases in activity of neurons in PO thalamus. We developed a novel model with two unique features: (1) blast-TBI was performed in awake, un-anesthetized rats, to simulate the human experience and to eliminate confounds of anesthesia and surgery inherent in other models; (2) only the cranium, rather than the entire body, was exposed to a collimated blast wave, with the blast wave striking the posterior cranium in the region of the occipital crest and foramen magnum. Three weeks after blast-TBI, rats developed persistent, ongoing spontaneous pain. Contrary to our hypothesis, we found no significant differences in the activity of PO neurons, or of neurons in the spinal trigeminal nucleus. There were also no significant changes in gliosis in either of these structures. This novel model will allow future studies on the pathophysiology of chronic pain after blast-TBI. © 2019 The Authors
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  University of Maryland Baltimore Foundation, Inc. Financial Statements Years Ended June 30, 2018 and 2017

  BDO USA, LLP (2018-10-09)

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