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Following the Money
The two first reflections on the politics of money you will see in Eich’s book, a substantial intervention (indeed, the notes are fully one-third the length of the main text itself), come from the visual arts and poetry. Commented upon at the end of his book, the cover image comes from Otis Kaye’s simultaneously playful and biting memento of the Met’s 1961 purchase of Rembrandt’s shimmering 1653 painting, Aristotle with a Bust of Homer. At some 2.3 million dollars, it was the most expensive museum purchase of all time. And Kaye (who seems to have lost most of his own savings in the great crash of 1929) offers both an homage, recreating the main figure of Aristotle with his hand on the bust of a representation of Homer, and a mordant reflection. The trompe l’oeil qualities of paper money in the painting hark back to earlier inflationary economics with the French revolutionary assignats, whose history found renewed interest among those trying to account for German hyperinflation and the Great Depression. Similarly, around Kaye’s edges, the dark intensity of Rembrandt’s background peels away to reveal utilitarian paneling, into which are fixed and interlaced wodges of cash, alongside other symbols of money making. The Heart of the Matter is more than just a wry reflection on the imbrication of art and commerce, or of Rembrandt interpretation—fleeting worldly fame, or lasting reputation. For while its truth seems superficially obvious—that the art world and the art market are inseparable—it is not entirely clear what sort of lesson we are supposed to learn about money. It is on the surface and under it, the base and the superstructure, form and content, style as well as substance. Is it telling us that a society where money is king is one that cannot see the truth of things, or that money, or at least the having of it, is what allows us not to think about it too much?
Journal Article
MALTHUSIAN MOMENTS IN THE WORK OF JOHN MAYNARD KEYNES
This article tracks the shifting contours of John Maynard Keynes's invocation of certain ideas associated with Thomas Robert Malthus, between 1914 and 1937 especially. These 'Malthusian moments' in Keynes's work form a triptych. In pre-war thinking about global population dynamics as a Malthusian 'devil' threatening national political and economic stability, Keynes found optimism in the thought that modern political economy could be repurposed to avoid the horns of such a dilemma. In the 1920s, he moved to consider the international, and particularly European, responses to both population and to the developing Malthusian 'devil' of unemployment. Finally, in the 1930s, Keynes's view became increasingly domestic, focusing on ways that these devilish twin problems could be managed by nation-states organized for prosperity and self-sufficiency. Across these moments, Keynes sought to assert the power of past political and economic ideas to aid in the formulation of present policy, by continuously (if rather loosely) invoking the Malthusian trope of 'effective demand'.
Journal Article
Pooled analysis of routine safety parameters observed in healthy participants at baseline and following placebo administration in early phase clinical studies
Phase I trials inform on the initial safety profile of a new molecule and impact whether further development is pursued or not. Understanding the effect of non‐pharmacological factors on the variability of routine safety parameters could improve decision making in these early clinical trials, helping to separate signals related to the new molecule from background “noise.” To understand the impact of non‐pharmacological factors on routine safety parameters, we evaluated pooled safety data from over 1000 healthy participants treated with placebo in phase I trials between 2009 and 2018. The phase I participants were predominantly men, less than or equal to 50 years, White, and non‐Hispanic; and approximately an equal proportion had body mass index in the normal and overweight/obese range. Following administration of placebo, vital signs, electrocardiogram, and laboratory parameters remained near predose baseline values. Large changes from baseline were observed for many safety parameters, but these occurred in a relatively small number of participants. At least one adverse event (AE) occurred in 49.7% of participants receiving placebo in single ascending dose (SAD) studies and in 72.4% of participants receiving placebo in multiple ascending dose (MAD) studies, with headache being the most commonly reported AE (18.7% in SAD and 28.3% in MAD studies). Overall, these analyses are consistent with non‐pharmacological factors having a small impact on routine safety parameters in a phase I trial. The provided supplemental data may be used to contextualize the magnitude and frequency of abnormal safety values and AEs observed in phase I trials.
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Assessment of pharmacokinetics, safety, and tolerability following twice‐daily administration of molnupiravir for 10 days in healthy participants
Molnupiravir is an orally administered, small‐molecule ribonucleoside prodrug of β‐D‐N4‐hydroxycytidine (NHC) that has demonstrated potent, broad‐spectrum preclinical activity against RNA viruses and has a high barrier to the development of resistance. A double‐blind, placebo‐controlled, phase I trial was conducted to evaluate the pharmacokinetics (PKs), safety, and tolerability of 10.5‐day administration of multiple doses of molnupiravir and its metabolites in healthy, adult participants. Participants were randomly assigned (3:1) to receive molnupiravir (400 mg [ n = 6], 600 mg [ n = 6], and 800 mg [ n = 12]) or matching placebo ( n = 8) every 12 h (q12h) for 10.5 days. Blood was collected to evaluate the PKs of NHC in plasma and of its active metabolite, NHC‐triphosphate (NHC‐TP), in peripheral blood mononuclear cells (PBMCs). Molnupiravir was generally well‐tolerated. All adverse events were mild or moderate in severity and none led to treatment discontinuation. No clinically meaningful dose‐related safety findings were observed. Mean time to maximal concentration was ~1.50 to 1.98 h for plasma NHC and ~4.00 to 8.06 h for PBMC NHC‐TP. Accumulation was minimal (<1.2) for NHC and ~2‐ to 2.5‐fold for NHC‐TP. Plasma NHC PKs was generally dose proportional, and PBMC NHC‐TP PKs was less than dose proportional over the dose range studied. NHC and NHC‐TP PK support twice‐daily administration. Overall, molnupiravir administered at up to 800 mg q12h for 10.5 days was generally well‐tolerated in healthy participants with dose‐linear PKs, supporting the evaluation of longer molnupiravir dosing up to 10 days in future clinical trials.
Journal Article
MALTHUSIAN MOMENTS
School of Humanities and Languages, University of New South Wales, Morven Brown Building, 243, Sydney, NSW 2052 a.bashford@unsw.edu.au Centre of Development Studies, University of Cambridge, Alison Richard Building, 7 West Road, Cambridge, cb3 9dt ss141@cam.ac.uk Department of Politics and International Studies, University of Cambridge, Alison Richard Building, 7 West Road, Cambridge, cb3 9dt djk36@cam.ac.uk This special issue is based on papers given at Malthus: Food Land People, a conference held at Jesus College, Cambridge, and at the Centre for Research in Arts, Humanities, and Social Sciences, Cambridge, in June 2016. The 250th anniversary of the political economist's birth saw a suite of Malthus studies appear around 2016, building on a set of revisions in 1998, the bicentennial of the Essay’s publication.1 Yet far from exhausting analysis, this scholarship has ignited further interest in Malthus's political economy of population, its reception and impact over place and time, and its purchase across a range of historiographical traditions. By seeking to signal something about the lessons of Malthus as an economic thinker for a world in which the twin ‘evils’ of unemployment and population expansion seemed all too real, Keynes returned to classical questions in the history of political economy, about whether competition (for resources and profit, between peoples and between states) was more likely to lead to peace through the mechanics of doux commerce, or to war through jealousy of trade. For decades professor of political economy at the East India Company College in Haileybury, he could hardly avoid an intercontinental and imperial framing of commerce, wealth, land, labour, and value.
Journal Article
A phase I, randomized, placebo‐controlled study of molnupiravir in healthy Japanese to support special approval in Japan to treat COVID‐19
Molnupiravir (MK‐4482) is an oral prodrug of the antiviral ribonucleoside analog, N‐hydroxycytidine (NHC), which has activity against RNA viruses, including severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2). We conducted a phase I safety and pharmacokinetic study of molnupiravir in healthy Japanese adult participants. A sample size larger than typically used in pharmacokinetic studies was implemented to collect additional safety data in the Japanese population to support special approval for emergency use in Japan. Single doses of molnupiravir up to 1600 mg and multiple doses of 400 and 800 mg administered every 12 h (q12h) for 5.5 days were generally well‐tolerated. NHC appeared rapidly in plasma and reached maximum concentration (Cmax), with a median time to Cmax (Tmax) between 1.00 and 2.00 h. Area under the concentration versus time curve from zero to infinity (AUC0–inf), area under the concentration versus time curve from zero to 12 h (AUC0–12), and Cmax of plasma NHC increased approximately dose proportionally. With q12h dosing, the geometric mean (GM) accumulation ratios for NHC AUC0–12 and Cmax were ~1 for 400 and 800 mg. Pharmacokinetics of NHC triphosphate (NHC‐TP), the active metabolite of NHC was assessed in peripheral blood mononuclear cells and also demonstrated roughly dose proportional pharmacokinetics. The GM accumulation ratios for NHC‐TP AUC0–12 and Cmax were ~2.5 for 400 and 800 mg. Following administration with food, only a modest reduction (24%) in plasma NHC Cmax with comparable AUC0–inf was seen, supporting administration without regard to food.
Journal Article
Introduction: Carl Schmitt's Critique of Friedrich Meinecke
This is an introduction to a new translation, by Keith Tribe, of Carl Schmitt's review of Friedrich Meinecke's Die Idee der Staatsräson (1924) from the Archiv für Sozialwissenschaft und Sozialpolitik (1926). It offers a brief overview of Meinecke's thinking about the relationship between politics and morality, and the possibility of a bridge being built between the two spheres by an ethically and culturally grounded form of reason of state. It was precisely this sort of moralized historical writing that Schmitt rejected, and in his rejection of it (a rejection mirrored in fact by Reinhard Koselleck) he returned to the sorts of conceptually aware, and politically realistic forms of argument found in the work of Max Weber.
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