The Limits of Government Regulation of Science

The recent controversy over the National Science Advisory Board for Biosecurity’s (NSABB) request that Science and Nature redact key parts of two papers on transmissible avian (H5N1) influenza reveal a troubled relationship between science and security. While NSABB’s request does not violate the First Amendment, efforts to censor the scientific press by force of law would usually be an unconstitutional prior restraint of the press absent a compelling state interest. The constitutional validity of conditions on grant funding to require pre-publication review of unclassified research is unclear but also arguably unconstitutional. The clearest case where government may restrict publication is when research has been properly classified as a security risk. It is less clear whether government may suppress the publication of “controlled unclassified information” (CUI). The key inquiry is whether the information poses a genuine security risk and the restraint is the least restrictive alternative. At the same time, the federal government has fairly broad latitude to protect sensitive data in its sole possession from disclosure under FOIA. We propose that future decisions on dual-use research should be taken through a fair and transparent institutional review process, likely best modeled on the institutional biosafety committees required for recombinant DNA research

Science, Politics, and Values: The Politicization of Professional Practice Guidelines

The Connecticut Attorney General’s recent allegations that the Infectious Disease Society of America violated antitrust law through its treatment guidelines for Lyme disease were neither based in sound science or appropriate legal judgment. Strong scientific evidence favors IDSA’s position that chronic infection with the etiologic agent of Lyme disease does not occur in the absence of objective signs of ongoing infection and that long-term antibiotic use to treat dubious infection, recommended in the quasi-scientific guidelines put forth by the International Lyme and Associated Diseases Society (ILADS), are of no benefit. In siding with ILADS and other chronic Lyme disease advocates, ultimately forcing IDSA to settle lest it expend exorbitant legal costs, the attorney general abused science and his public trust. This case exemplifies the politicization of health policy and confuses the relative spheres inhabited by normative discourse and scientific inquiry. Science should provide the evidentiary base for normative discussions, and values and politics will always be important in deciding how science is applied for human benefit. But a wall of separation is needed between science, values, and politics, as medical science, and the patients who depend on it, is too important for political distortion

Probing the Complex and Variable X-ray Absorption of Markarian 6 with XMM-Newton

We report on an X-ray observation of the Seyfert 1.5 galaxy Mrk 6 obtained with the EPIC instruments onboard XMM-Newton. Archival BeppoSAX PDS data from 18-120 keV were also used to constrain the underlying hard power-law continuum. The results from our spectral analyses generally favor a double partial-covering model, although other spectral models such as absorption by a mixture of partially ionized and neutral gas cannot be firmly ruled out. Our best-fitting model consists of a power law with a photon index of 1.81+/-0.20 and partial covering with large column densities up to 10^{23} cm**-2. We also detect a narrow emission line consistent with Fe Kalpha fluorescence at 6.45+/-0.04 keV with an equivalent width of ~93+/-25 eV. Joint analyses of XMM-Newton, ASCA, and BeppoSAX data further provide evidence for both spectral variability (a factor of ~2 change in absorbing column) and absorption-corrected flux variations (by ~60%) during the ~4 year period probed by the observations.Comment: 7 pages, 2 figures. accepted for publication in the Astronomical Journa

Are low tolerable upper intake levels for vitamin a undermining effective food fortification efforts?

Vitamin A deficiency (VAD) is a major health problem, particularly in low-resource countries, putting an estimated 125-130 million preschool-aged children at increased risk of morbidity and mortality from infectious diseases. Vitamin A supplementation reduces VAD and increases child survival; it is complemented by fortifying foods with vitamin A. Concern over increased risk of bone fracture associated with vitamin A intakes below the tolerable upper intake level (UL) among populations in affluent countries conflicts with the need to increase intakes in less developed countries, where populations are at greater risk of VAD and intakes are unlikely to reach the UL as diets include fewer foods containing retinol while vitamin A from carotenoids poses no risk of overdose. With the implementation of recently developed risk management tools, vitamin A can be used safely in food fortification, including point-of-use fortification in the context of supplementation among specific target groups in low-resource countrie

COVID-19 vaccine uptake, confidence and hesitancy in rural KwaZulu-Natal, South Africa between April 2021 and April 2022: A continuous cross-sectional surveillance study

High COVID-19 vaccine hesitancy in South Africa limits protection against future epidemic waves. We evaluated how vaccine hesitancy and its correlates evolved April 2021-April 2022 in a well-characterized rural KwaZulu-Natal setting. All residents aged >15 in the Africa Health Research Institute's surveillance area were invited to complete a home-based, in-person interview. We described vaccine uptake and hesitancy trends, then evaluated associations with pre-existing personal factors, dynamic environmental context, and cues to action using ordinal logistic regression. Among 10,011 respondents, vaccine uptake rose as age-cohorts became vaccine-eligible before levelling off three months post-eligibility; younger age-groups had slower uptake and plateaued faster. Lifetime receipt of any COVID-19 vaccine rose from 3.0% in April-July 2021 to 32.9% in January-April 2022. Among 7,445 unvaccinated respondents, 47.7% said they would definitely take a free vaccine today in the first quarter of the study time period, falling to 32.0% in the last. By March/April 2022 only 48.0% of respondents were vaccinated or said they would definitely would take a vaccine. Predictors of lower vaccine hesitancy included being male (adjusted odds ratio [aOR]: 0.70, 95% confidence interval [CI]: 0.65-0.76), living with vaccinated household members (aOR:0.65, 95%CI: 0.59-0.71) and knowing someone who had had COVID-19 (aOR: 0.69, 95%CI: 0.59-0.80). Mistrust in government predicted greater hesitancy (aOR: 1.47, 95%CI: 1.42-1.53). Despite several COVID-19 waves, vaccine hesitancy was common in rural South Africa, rising over time and closely tied to mistrust in government. However, interpersonal experiences countered hesitancy and may be entry-points for interventions

Effects of Concurrent Resistance and Aerobic Training on Load-Bearing Performance and the Army Physical Fitness Test

The purpose of this research was to determine the effects of high intensity endurance training (ET) and resistance training (RT) alone and in combination on various military tasks. Thirty-five male soldiers were randomly assigned to one of four training groups: total body resistance training plus endurance training (RT + ET), upper body resistance training plus endurance training [UB + ET), RT only, and ET only. Training was performed 4 days per week for 12 weeks. Testing occurred before and after the 12-week training regimen. All groups significantly improved push-up performance, whereas only the RT + ET group did not improve sit-up performance. The groups that included ET significantly decreased 2-mile run time, however, only RT + ET and UB + ET showed improved loaded 2-mile run time. Leg power increased for groups that included lower body strengthening exercises (RT and RT + ET). Army Physical Fitness Test performance, loaded running, and leg power responded positively to training, however, it appears there is a high degree of specificity when concurrent training regimens are implemented

Aptamer-based multiplexed proteomic technology for biomarker discovery

Interrogation of the human proteome in a highly multiplexed and efficient manner remains a coveted and challenging goal in biology. We present a new aptamer-based proteomic technology for biomarker discovery capable of simultaneously measuring thousands of proteins from small sample volumes (15 [mu]L of serum or plasma). Our current assay allows us to measure ~800 proteins with very low limits of detection (1 pM average), 7 logs of overall dynamic range, and 5% average coefficient of variation. This technology is enabled by a new generation of aptamers that contain chemically modified nucleotides, which greatly expand the physicochemical diversity of the large randomized nucleic acid libraries from which the aptamers are selected. Proteins in complex matrices such as plasma are measured with a process that transforms a signature of protein concentrations into a corresponding DNA aptamer concentration signature, which is then quantified with a DNA microarray. In essence, our assay takes advantage of the dual nature of aptamers as both folded binding entities with defined shapes and unique sequences recognizable by specific hybridization probes. To demonstrate the utility of our proteomics biomarker discovery technology, we applied it to a clinical study of chronic kidney disease (CKD). We identified two well known CKD biomarkers as well as an additional 58 potential CKD biomarkers. These results demonstrate the potential utility of our technology to discover unique protein signatures characteristic of various disease states. More generally, we describe a versatile and powerful tool that allows large-scale comparison of proteome profiles among discrete populations. This unbiased and highly multiplexed search engine will enable the discovery of novel biomarkers in a manner that is unencumbered by our incomplete knowledge of biology, thereby helping to advance the next generation of evidence-based medicine

Methods for specifying the target difference in a randomised controlled trial : the Difference ELicitation in TriAls (DELTA) systematic review

Peer reviewedPublisher PD