Proposal for a national diagnostics action plan for the United States.

Providing a definitive diagnostic test in a disease emergency is critical to limit pathogen spread, develop and deploy medical countermeasures, and mitigate the social and economic harms of a serious epidemic. While major accomplishments have accelerated test development, expanded laboratory testing capacity, and established widespread point-of-care testing, the United States does not have a plan to rapidly respond, to develop, manufacture, deploy, and sustain diagnostic testing at a national scale. To address this gap, we are proposing a National Diagnostics Action Plan that describes the steps that are urgently needed to prepare for future infectious disease emergencies, as well as the actions we must take at the first signs of such' events. These recommendations require substantial collaboration between the US government (USG) and the private sector to solve a series of challenges now, as well as to prepare for the massive and rapid scale-up of laboratory and point-of-care test development and testing capacity in future emergencies. The recommendations include establishing pre-event contracts; ensuring rapid access to clinical samples; creating a permanent public-private testing coordinating body to allow for rapid information sharing and improved cooperation among the USG, test developers, and clinical laboratories; and accelerating testing rollout at the beginning of an event-and thus, the effective public health management of a disease crisis.

The burden of comedication among patients with inflammatory bowel disease.

BACKGROUND: Polypharmacy is of growing concern in the chronically ill, including individuals with inflammatory bowel disease (IBD). The authors aimed to describe the prevalence and predictors of non-IBD medication use and to compare drug use among individuals with and without IBD. METHODS: This cross-sectional study included members of health plans included in the Thomson Reuters MarketScan databases with continuous enrollment during 2009 and 2010. Patients with IBD were identified through diagnosis codes and IBD medication dispensings and matched to 5 individuals without IBD. The prevalences of dispensed prescriptions for analgesics (narcotics, nonnarcotics), psychiatric medications (anxiolytics/sedatives/hypnotics, antidepressants), and broad drug classes defined by the Anatomic Therapeutic Classification system were estimated. Predictors of non-IBD medication use and comparisons of drug use by IBD status were evaluated using logistic regression. RESULTS: The prevalence of medication use was higher among patients with IBD than matched members of the general population for nearly every drug class examined, including narcotic analgesics (48.1% versus 34.1%), nonnarcotic analgesics (12.8% versus 8.1%), anxiolytics/sedatives/hypnotics (25.8% versus 16.7%), and antidepressants (28.3% versus 19.4%). Medicaid insurance, middle age, gastrointestinal surgery, Crohn's disease, and increasing number of inpatient, and outpatient, and prescription events were significantly associated with analgesic and psychiatric medication use among patients with IBD. Psychiatric drug dispensings were more common among female IBD patients than male patients. CONCLUSIONS: Patients with IBD have increased medication use, particularly of analgesic and psychiatric drugs. IBD care providers should be aware of polypharmacy and its potential for drug interactions.

Mirtazapine vs. placebo in posttraumatic stress disorder: a pilot trial.

BACKGROUND: Based on an earlier pilot study, as well as a theoretical consideration of its mechanism of action, we undertook a placebo-controlled, double-blind trial of mirtazapine in posttraumatic stress disorder. METHODS: Twenty-nine patients were randomized to receive drug up to 45 mg/day or placebo double-blind on a 2:1 ratio for 8 weeks, with data being available for analysis in 26. Primary outcome measures comprised the Short Posttraumatic Stress Disorder Rating Interview (SPRINT) Global Improvement item and total score. Secondary measures comprised the Davidson Trauma Scale, Structured Interview for Posttraumatic Stress Disorder and Hospital Anxiety Depression Scale. Adverse events were also measured. RESULTS: On the Short Posttraumatic Stress Disorder Rating Interview Global Improvement measure, rates of response were 64.7% and 20.0% for mirtazapine and placebo. Treatment effects in favor of mirtazapine were noted on the Short Posttraumatic Stress Disorder Rating Interview global, Structured Interview for Posttraumatic Stress Disorder, and Hospital Anxiety Depression Scale anxiety subscale scores. The drug was well tolerated. CONCLUSIONS: Mirtazapine was more effective than placebo on some measures in posttraumatic stress disorder and general anxiety symptoms.

Investigation of Notch3 as a candidate gene for bipolar disorder using brain hyperintensities as an endophenotype.

The purpose of the study was to consider MRI hyperintensities as a potential endophenotype for bipolar disorder (BPD) and to investigate Notch3 (CADASIL) as a candidate gene for BPD. MRI scans were performed on 21 members of a family with a high incidence of BPD. Two-point and multipoint linkage analyses were performed and two exons of Notch3 were investigated with SSCP. Fifteen of 21 family members had MRI hyperintensities, including all bipolar patients and six family members with no affective illness. Two-point linkage analysis yielded negative results for all models. Multipoint linkage analysis yielded negative results except for Model 1a, in which a maximal LOD score was -1.24. A mutation screen of Exons 3 and 4 was negative. Notch3 does not appear to be a candidate gene for BPD in this family.