Commoning genomic solidarity to improve global health equality.

This article underlines two key asynchronies between prevailing governing logic and expanding practices in somatic human genome editing that are hindering an effective and orderly translation of the new technology into public good. The first is a "genomic sovereignty" framing adopted by a number of non-Western countries that may exacerbate data biases in global research and that directs policy attention away from the necessary structural changes required to achieve non-discriminatory and equitable genomic healthcare. The other is a global deficiency in attending to "science at large": the challenge of regulating new assemblages of societal interests that advocate controversial or experimental research, often outside of conventional institutions and aided by "policy shopping." Both issues point to the fact that genomic research does not represent a well-defined scientific commons but rather a domain that requires active "commoning," with the aim of fostering genomic solidarity that coordinates responsible research within and across national boundaries.

To Procrastinate or Not to Procrastinate: A Retrospective Study of the Optimal Timing of Containing the Global Spread of the COVID-19 Pandemic.

As global public health is under threat by the 2019-nCoV and a potential new wave of large-scale epidemic outbreak and spread is looming, an imminent question to ask is what the optimal strategy of epidemic prevention and control (P&C) measures would be, especially in terms of the timing of enforcing aggressive policy response so as to maximize health efficacy and to contain pandemic spread. Based on the current global pandemic statistic data, here we developed a logistic probability function configured SEIR model to analyse the COVID-19 outbreak and estimate its transmission pattern under different "anticipate- or delay-to-activate" policy response scenarios in containing the pandemic. We found that the potential positive effects of stringent pandemic P&C measures would be almost canceled out in case of significantly delayed action, whereas a partially procrastinatory wait-and-see control policy may still be able to contribute to containing the degree of epidemic spread although its effectiveness may be significantly compromised compared to a scenario of early intervention coupled with stringent P&C measures. A laissez-faire policy adopted by the government and health authority to tackling the uncertainly of COVID19-type pandemic development during the early stage of the outbreak turns out to be a high risk strategy from optimal control perspective, as significant damages would be produced as a consequence.

Iron stores at birth in a full-term normal birth weight birth cohort with a low level of inflammation.

Iron stores at birth are essential to meet iron needs during the first 4-6 months of life. The present study aimed to investigate iron stores in normal birth weight, healthy, term neonates. Umbilical cord blood samples were collected from apparently normal singleton vaginal deliveries (n=854). Subjects were screened and excluded if C-reactive protein (CRP) > 5 mg/l or α1-acid glycoprotein (AGP) > 1 g/l, preterm (<37 complete weeks), term < 2500g or term > 4000g. In total, 762 samples were included in the study. Serum ferritin, soluble transferrin receptor (sTfR), hepcidin, and erythropoietin (EPO) were measured in umbilical cord blood samples; total body iron (TBI) (mg/kg) was calculated using sTfR and ferritin concentrations. A total of 19.8% newborns were iron deficient (ferritin 35 µg/l) and an additional 46.6% had insufficient iron stores (ferritin < 76 µg/l). There was a positive association between serum ferritin and sTfR, hepcidin, and EPO. Gestational age was positively associated with ferritin, sTfR, EPO, and hepcidin. In conclusion, we demonstrate a high prevalence of insufficient iron stores in a Chinese birth cohort. The value of cord sTfR and TBI in the assessment of iron status in the newborn is questionable, and reference ranges need to be established.

Cord serum vitamin D in a South China birth cohort.

BACKGROUND AND OBJECTIVES: Vitamin D deficiency during pregnancy has been associated with many adverse pregnancy and birth outcomes. Low serum 25-hydroxyvitamin D (25OHD) levels (<30 nmol/L) increases the risk of nutritional rickets. This study aimed to investigate the concentration of cord serum 25OHD in a birth cohort in Guangzhou, China and determine whether maternal lifestyle factors had any effect on these levels. METHODS AND STUDY DESIGN: A total of 854 pregnant women giving birth between Dec 2016 and Dec 2017 were recruited to this study. Basic information was obtained from the clinical database. A voluntary retrospective pregnancy lifestyle questionnaire was completed by 388 participants. The concentration of serum 25OHD, calcium, phosphorus, and alkaline phosphatase (ALP) were measured in umbilical cord blood. RESULTS: The mean (SD) of cord serum 25OHD was 44.7 (16.7) nmol/L. The prevalence of cord 25OHD <30 nmol/L was 22.2% and 70.4% had levels <50 nmol/L. The prevalence of vitamin D deficiency is higher in infants born in winter months (31% <30 nmol/L and 76% <50 nmol/L), compared to those born in the summer (12% <30 nmol/L and 64% <50 nmol/L). Infants born to women taking a vitamin D containing supplement had approximately 10 nmol/L higher levels of 25OHD than those who did not supplement their diets. CONCLUSIONS: Summer born infants have higher serum 25OHD levels at birth, but there are still infants being born with vitamin D deficiency. Vitamin D containing supplement use during pregnancy was effective in raising cord serum vitamin D levels.

How to Be Modern? The Social Negotiation of 'Good Food' in Contemporary China.

Developing safe and sustainable food production for its population has been central to China's 'Modernisation Project'. Yet recent fieldwork in three Chinese cities suggests that there are two conflicting views on what a 'modern' agriculture should look like. For the government, modernisation implies a rational calculation of scale and a mirroring of global trends. But an alternative interpretation of modernity, promoted by civil society, has been gaining ground. For this camp, good food production is then established through a 'rhizomic' spread of new practices, which are inspired by world possibilities but are deeply rooted in the local context. Based on 14 interviews and five focus groups, this article investigates the ongoing social negotiation of 'good food' in China. It demonstrates how a non-western society responds to the twin processes of modernisation and globalisation and provides insights on the varieties of modernity in the making.

Lost in translation? Accountability and governance of clinical stem cell research in China.

Despite China's regulatory initiatives to promote its research accountability, it still needs to prove itself as a trusted player in life science research. In addition, in contrast to its huge investment, China is losing the race in delivering quality application of stem cells. The trial implementation of the 2015 ministerial regulations seemed to offer hope in ending this dual 'lost-in-translation'. Yet skepticism remains. By examining China's regulatory trajectory in the last 15 years, this paper illustrates that it is a post hoc pragmatic policy rationale and a soft centralization regulatory approach that have hampered China's governance. To improve China's governance of accountability, policy-makers need to get beyond an 'act-in-response' regulatory ethos and to engage with diverse stakeholders.

Baseline Assessment of 25-Hydroxyvitamin D Reference Material and Proficiency Testing/External Quality Assurance Material Commutability: A Vitamin D Standardization Program Study.

The Vitamin D Standardization Program (VDSP) coordinated a study in 2012 to assess the commutability of reference materials and proficiency testing/external quality assurance materials for total 25-hydroxyvitamin D [25(OH)D] in human serum, the primary indicator of vitamin D status. A set of 50 single-donor serum samples as well as 17 reference and proficiency testing/external quality assessment materials were analyzed by participating laboratories that used either immunoassay or LC-MS methods for total 25(OH)D. The commutability test materials included National Institute of Standards and Technology Standard Reference Material 972a Vitamin D Metabolites in Human Serum as well as materials from the College of American Pathologists and the Vitamin D External Quality Assessment Scheme. Study protocols and data analysis procedures were in accordance with Clinical and Laboratory Standards Institute guidelines. The majority of the test materials were found to be commutable with the methods used in this commutability study. These results provide guidance for laboratories needing to choose appropriate reference materials and select proficiency or external quality assessment programs and will serve as a foundation for additional VDSP studies.

Baseline Assessment of 25-Hydroxyvitamin D Assay Performance: A Vitamin D Standardization Program (VDSP) Interlaboratory Comparison Study.

The Vitamin D Standardization Program (VDSP) coordinated an interlaboratory study to assess the comparability of measurements of total 25-hydroxyvitamin D [25(OH)D] in human serum, which is the primary marker of vitamin D status. A set of 50 individual donor samples were analyzed by 15 different laboratories representing national nutrition surveys, assay manufacturers, and clinical and/or research laboratories to provide results for total 25(OH)D using both immunoassays (IAs) and LC tandem MS (MS/MS). The results were evaluated relative to bias compared with the target values assigned based on a combination of measurements at Ghent University (Belgium) and the U.S. National Institute of Standards and Technology using reference measurement procedures for the determination of 25(OH)D2 and 25(OH)D3. CV and mean bias for each laboratory and assay platform were assessed and compared with previously established VDSP performance criteria, namely CV ≤ 10% and mean bias ≤ 5%. Nearly all LC-MS/MS results achieved VDSP criteria, whereas only 50% of IAs met the criterion for a ≤10% CV and only three of eight IAs achieved the ≤5% bias. These results establish a benchmark for the evaluation of 25(OH)D assay performance and standardization activities in the future.

Vitamin D status is associated with uteroplacental dysfunction indicated by pre-eclampsia and small-for-gestational-age birth in a large prospective pregnancy cohort in Ireland with low vitamin D status.

BACKGROUND: Associations between vitamin D and pregnancy outcomes have been inconsistent. OBJECTIVES: We described the distribution of 25-hydroxyvitamin D3 [25(OH)D3], 3-epi-25(OH)D3, and 25(OH)D2 in early pregnancy and investigated associations with pre-eclampsia and small-for-gestational-age (SGA) birth, which are indicative of uteroplacental dysfunction. DESIGN: The SCOPE (Screening for Pregnancy Endpoints) Ireland prospective pregnancy cohort study included 1768 well-characterized low-risk, nulliparous women resident at 52°N. Serum 25(OH)D3, 3-epi-25(OH)D3, and 25(OH)D2 were quantified at 15 wk of gestation with the use of a CDC-accredited liquid chromatography-tandem mass spectrometry method. RESULTS: The mean ± SD total 25(OH)D concentration was 56.7 ± 25.9 nmol/L, and 17% and 44% of women had 25(OH)D concentrations <30 and <50 nmol/L, respectively. The prevalence of pre-eclampsia was 3.8%, and 10.7% of infants were SGA. There was a lower risk of pre-eclampsia plus SGA combined (13.6%) at 25(OH)D concentrations >75 nmol/L (adjusted OR: 0.64; 95% CI: 0.43, 0.96). The main predictors of 25(OH)D were the use of vitamin D-containing supplements (adjusted mean difference: 20.1 nmol/L; 95% CI: 18.5, 22.7 nmol/L) and summer sampling (adjusted mean difference: 15.5 nmol/L; 95% CI: 13.4, 17.6 nmol/L). Non-Caucasian ethnicity (adjusted mean difference: -19.3 nmol/L; 95% CI: -25.4, -13.2 nmol/L) and smoking (adjusted mean difference: -7.0 nmol/L; 95% CI: -10.5, -3.6 nmol/L) were negative predictors of 25(OH)D. The mean ± SD concentration of 3-epi-25(OH)D3, which was detectable in 99.9% of samples, was 2.6 ± 1.6 nmol/L. Determinants of 3-epi-25(OH)D3 were 25(OH)D3 (adjusted mean difference: 0.052 nmol/L; 95% CI: 0.050, 0.053 nmol/L) and maternal age (adjusted mean difference: -0.018 nmol/L; 95% CI: -0.026, -0.009 nmol/L). The mean ± SD concentration of 25(OH)D2 was 3.1 ± 2.7 nmol/L, which was present in all samples. No adverse effects of 25(OH)D concentrations >125 nmol/L were observed. CONCLUSIONS: In the first report to our knowledge of CDC-accredited 25(OH)D data and pregnancy outcomes from a large, clinically validated, prospective cohort study, we observed a protective association of a 25(OH)D concentration >75 nmol/L and a reduced risk of uteroplacental dysfunction as indicated by a composite outcome of SGA and pre-eclampsia. Well-designed, adequately powered randomized controlled trials are required to verify this observation. The SCOPE pregnancy cohort was registered at www.anzctr.org.au as ACTRN12607000551493.

Impact of pregnancy on vitamin D status: a longitudinal study.

Nutritional requirements for vitamin D during pregnancy have been inadequately described, and there are conflicting data on the impact of gestation on vitamin D status. In the present study, we conducted a longitudinal analysis of total and free (unbound) serum 25-hydroxyvitamin D (25(OH)D), vitamin D-binding protein (DBP) and albumin concentrations in a random sample of thirty women from the Screening for Pregnancy Endpoints Ireland pregnancy cohort study at 15, 20, 24, 28, 32, 36 and 40 weeks of gestation and at 2 months postpartum. Concentrations of serum 25(OH)D, DBP and albumin were determined, and free 25(OH)D was calculated from the concentrations of total 25(OH)D, DBP and albumin. Serum albumin concentration decreased during pregnancy (P< 0·001), with a nadir at 36 weeks (P< 0·005), during which the concentration was approximately 80 % of the postnatal concentration. Serum DBP concentration increased during pregnancy and at 28 weeks of gestation, which was almost double the postnatal level (P< 0·001). Total and free 25(OH)D concentrations decreased (both P< 0·005) as pregnancy progressed, and both were lowest at 36 weeks of gestation. At 15 weeks, 10 and 63 % of the women had serum 25(OH)D concentration < 30 and 50 nmol/l, respectively, which increased to 53 and 80 % at 36 weeks of gestation. The time course of decreasing concentrations of 25(OH)D during gestation among women recruited during May-July, who delivered between October and November, and among those recruited in August-September, who delivered between February and March, was similar. The lower percentage of free 25(OH)D during pregnancy is mainly due to increased DBP.

Dietary calcium does not interact with vitamin D3 in terms of determining the response and catabolism of serum 25-hydroxyvitamin D during winter in older adults.

BACKGROUND: Interactions between calcium and vitamin D may have implications for the regulation of serum 25-hydroxyvitamin D [25(OH)D] and its catabolism and, consequently, the vitamin D dietary requirement. OBJECTIVE: We investigated whether different calcium intakes influenced serum 25(OH)D and indexes of vitamin D activation and catabolism during winter and in the context of both adequate and inadequate vitamin D intakes. DESIGN: A 15-wk winter-based, randomized, placebo-controlled, double-blind vitamin D3 intervention (20 µg/d) study was carried out in free-living men and women aged ≥50 y (n = 125) who were stratified according to calcium intakes [moderate-low (<700 mg/d) or high (>1000 mg/d) intake]. The serum 25(OH)D concentration was the primary outcome, and serum calcium, parathyroid hormone (PTH), 1,25-dihydroxyvitamin D [1,25(OH)2D], 24,25-dihydroxyvitamin D [24,25(OH)2D], the ratio of 24,25(OH)2D to 25(OH)D, vitamin D-binding protein, and free 25(OH)D were exploratory outcomes. RESULTS: A repeated-measures ANOVA showed there was no significant (P = 0.2) time × vitamin D treatment × calcium intake grouping interaction effect on the mean serum 25(OH)D concentration over the 15-wk intervention period. Serum 25(OH)D concentrations increased (P ≤ 0.005) and decreased (P ≤ 0.002) in vitamin D3 and placebo groups, respectively, and were of similar magnitudes in subjects with calcium intakes <700 mg/d (and even <550 mg/d) compared with >1000 mg/d. The response of serum PTH, 1,25(OH)2D, 24,25(OH)2D, the ratio of 24,25(OH)2D to 25(OH)D, and free 25(OH)D significantly differed in vitamin D3 and placebo groups but not by calcium intake grouping. CONCLUSIONS: We found no evidence of a vitamin D sparing effect of high calcium intake, which has been referred to by some authors as "vitamin D economy." Thus, recent dietary vitamin D requirement estimates will cover the vitamin D needs of even those individuals who have inadequate calcium intakes.

The art of trans-boundary governance: the case of synthetic biology.

Synthetic biology raises few, if any, social concerns that are distinctively new. Similar to many other convergent technologies, synthetic biology's interface across various scientific communities and interests groups presents an incessant challenge to political and conceptual boundaries. However, the scale and intensity of these interfaces seem to necessitate a reflection over how corresponding governance capacities can be developed. This paper argues that, in addition to existing regulatory approaches, such capacities may be gained through the art of trans-boundary governance, which is not only attentive to the crossing and erosion of particular boundaries but also adept in keeping up with the dynamics among evolving networks of actors.