Suicides in National Hormone Pituitary Program Recipients of Cadaver-Derived Human Growth Hormone.

Context: Numerous reports of suicide among individuals who received cadaver-derived human growth hormone (c-hGH) through the National Hormone Pituitary Program (NHPP) raised the alarm for potentially increased suicide risk. Objective: We conducted a study to assess suicide risk in the NHPP cohort and identify contributing factors to facilitate early recognition and intervention. Methods: The study population consisted of patients receiving NHPP c-hGH starting from 1957, and cohort deaths with an ICD code consistent with suicide or possible suicide through 2020 were evaluated. Descriptive data were extracted from medical records. Standardized mortality ratios (SMRs) to compare the observed number of suicide deaths in the cohort to the expected number were calculated using general population suicide rates by sex, age group, and time period. Results: Among 6272 patients there were 1200 all-cause cohort deaths, of which 55 (52 male, 3 female) were attributed to suicide. Of these, 47 were identified by ICD code alone compared to an expected count of 37.8 (SMR = 1.25, 95% CI 0.91-1.66). Among male cohort members, the SMR was 1.33 (95% CI 0.97-1.78). Elevated risk of suicide was detected for cohort members aged 25-34 (SMR = 1.79, 95% CI 1.06-2.83) and during the period from September 19, 1985, to December 31, 1998 (SMR = 1.70, 95% CI 1.02-2.65). Conclusion: Overall, the observed number of suicides among NHPP c-hGH recipients was not significantly higher than expected. However, certain subgroups may be at elevated risk of suicide. Studies are needed to better understand the nature and magnitude of suicide risk among c-hGH recipients to facilitate early intervention to prevent suicide deaths.

Pivotal findings for a high-sensitivity cardiac troponin assay: Results of the HIGH-US study.

BACKGROUND: Cardiac troponin (cTn) is the keystone for diagnosis of acute myocardial infarction (AMI). We examined the analytical and diagnostic accuracy of the Atellica IM TnIH assay to determine high-sensitivity performance and appropriate diagnostic performance for clinical use. METHODS: Sex-specific 99th percentile upper reference limits (URLs) were determined for a healthy cohort of 1007 women and 1000 men using non-parametric statistics. High-sensitivity performance was assessed by examining if imprecision was ≤10% at sex-specific URLs and if ≥50% of cTnI values for each sex exceeded the assay's limit of detection (LoD) with the AACC Universal Sample Bank. Precision, high-dose hook effect, endogenous/exogenous interferences were examined with CLSI guidance. Clinical characterization was with 2494 suspected AMI subjects presenting to emergency departments across the United States. AMI was adjudicated by expert cardiologists and emergency medicine physicians. There were no comorbidity exclusions. RESULTS: 99th percentile URLs were 34 ng/L, 53 ng/L and 45 ng/L for the female, male and overall populations, respectively. Total imprecision was <5% from 12 ng/L to 16,000 ng/L; ≥55% of cTnI values for each sex exceeded the LoD. No high-dose hook or endogenous/exogenous interferences were identified. After 2.5-3.5 h post presentation the sensitivity and specificity were >90%; negative and positive predictive value were ≥98% and >60%, respectively. Non-AMI subjects with comorbidities and values exceeding 99th percentile URLs had absolute and percent change at 2-4 h that were lower than AMI patients with comorbidities (p = 0.001). CONCLUSION: The Atellica IM TnIH assay is a high-sensitivity method and demonstrates clinical performance appropriate for AMI diagnosis.

In utero arsenic exposure and infant infection in a United States cohort: a prospective study.

Arsenic (As), a ubiquitous environmental toxicant, has recently been linked to disrupted immune function and enhanced infection susceptibility in highly exposed populations. In drinking water, as levels above the EPA maximum contaminant level occur in our US study area and are a particular health concern for pregnant women and infants. As a part of the New Hampshire Birth Cohort Study, we investigated whether in utero exposure to As affects risk of infant infections. We prospectively obtained information on 4-month-old infants (n=214) using a parental telephone survey on infant infections and symptoms, including respiratory infections, diarrhea and specific illnesses, as well as the duration and severity of infections. Using logistic regression and Poisson models, we evaluated the association between maternal urinary As during pregnancy and infection risks adjusted for potentially confounding factors. Maternal urinary As concentrations were related to total number of infections requiring a physician visit (relative risk (RR) per one-fold increase in As in urine=1.5; 95% confidence interval (CI)=1.0, 2.1) or prescription medication (RR=1.6; 95% CI=1.1, 2.4), as well as lower respiratory infections treated with prescription medication (RR=3.3; 95% CI=1.2, 9.0). Associations were observed with respiratory symptoms (RR=4.0; 95% CI=1.0, 15.8), upper respiratory infections (RR=1.6; 95% CI=1.0, 2.5), and colds treated with prescription medication (RR=2.3; 95% CI=1.0, 5.2). Our results provide initial evidence that in utero As exposure may be related to infant infection and infection severity and provide insight into the early life impacts of fetal As exposure.