Andy Smith

Poor replication validity of biomedical association studies reported by newspapers.

Objective To investigate the replication validity of biomedical association studies covered by newspapers. Methods We used a database of 4723 primary studies included in 306 meta-analysis articles. These studies associated a risk factor with a disease in three biomedical domains, psychiatry, neurology and four somatic diseases. They were classified into a lifestyle category (e.g. smoking) and a non-lifestyle category (e.g. genetic risk). Using the database Dow Jones Factiva, we investigated the newspaper coverage of each study. Their replication validity was assessed using a comparison with their corresponding meta-analyses. Results Among the 5029 articles of our database, 156 primary studies (of which 63 were lifestyle studies) and 5 meta-analysis articles were reported in 1561 newspaper articles. The percentage of covered studies and the number of newspaper articles per study strongly increased with the impact factor of the journal that published each scientific study. Newspapers almost equally covered initial (5/39 12.8%) and subsequent (58/600 9.7%) lifestyle studies. In contrast, initial non-lifestyle studies were covered more often (48/366 13.1%) than subsequent ones (45/3718 1.2%). Newspapers never covered initial studies reporting null findings and rarely reported subsequent null observations. Only 48.7% of the 156 studies reported by newspapers were confirmed by the corresponding meta-analyses. Initial non-lifestyle studies were less often confirmed (16/48) than subsequent ones (29/45) and than lifestyle studies (31/63). Psychiatric studies covered by newspapers were less often confirmed (10/38) than the neurological (26/41) or somatic (40/77) ones. This is correlated to an even larger coverage of initial studies in psychiatry. Whereas 234 newspaper articles covered the 35 initial studies that were later disconfirmed, only four press articles covered a subsequent null finding and mentioned the refutation of an initial claim. Conclusion Journalists preferentially cover initial findings although they are often contradicted by meta-analyses and rarely inform the public when they are disconfirmed.

Varietals of Capitalism: A Political Economy of the Changing Wine Industry

Varietals of Capitalism shows that politics is an omnipresent part of the economics of wine and of economic activity in general. Based on a four-year research project encompassing fieldwork in France, Spain, Italy, and Romania, Xabier Itcaina, Antoine Roger, and Andy Smith examine the causes and effects of a radical reform adopted at the EU level in 2008. Regulatory change politically transformed the rationale of EU support to the wine industry, from shaping the supply side to encouraging producers to adapt to the demands of a supposedly new consumer.

How the European Commission’s Policies Are Made: Problematization, Instrumentation and Legitimation

Abstract How does the European Commission make its own policies? Research on EU policy-making has generated many indirect, informed answers to this question. However, a focus upon the Commission’s internal practices remains under-theorized and under-specified. Drawing upon constructivist, institutionalist and sociological policy analysis, this article instead mobilizes a generic approach to policy-making as ‘political work’ entailing three overlapping processes: problematization, instrumentation and legitimation. This conceptual framework is then applied to a comparison of Commission policy-making as regards the wine and pharmaceuticals industries. The principal finding is that there are three scope conditions for Commission policy-making which seeks deep institutional change: problematization must be precise rather than vague; instrumentation needs to be programmatic rather than dispersed; and commissioners and senior Commission officials must commit to sustained strategies of legitimation. Overall, this theory-driven approach to policy-making provides a means of shedding new light upon both the Commission and its role within European integration.

The Politics of Economic Activity

The Politics of Economic Activity confronts head-on deeply rooted understandings of how politics affects economics. The book proposes a robust, incisive alternative definition of politics: the mobilization of values to change or reproduce the institutions that orientate, and indeed make possible, economic activity. Drawing upon constructivist strands of institutionalism, political sociology, and industrial economics, this definition generates an analytical framework for understanding the political work that constantly orientates the behaviour of both firms and public authorities. Specifically, a fundamental tension between the values of freedom and security is consistently examined. This is analysed by looking at conflicts within the definition of these two values, but also by examination of mobilizations of two subordinate values: equality and tradition. A hypothesis examined throughout the books empirical chapters is that equality and tradition play either supporting, intervening, or silent roles within the freedom-security relationship that structures contemporary capitalism. Structured around controversies concerning the politics of economic activity at the global, European, national and local scales, the book examines the pharmaceutical, wine, local food, and car industries, as well as cross-cutting policies concerning issues such as regulating labour markets and inter-firm competition, geographical indications, and local economic development. Overall, the books aim is to advocate a mode of thinking and research which challenges orthodox and dominant approaches to economics and its politics. It does so by placing a politics that is comprehensible, and therefore both studyable and actionable, back at the centre of reflection about the economic and the political.

Impact of Medicine Withdrawal on Reporting of Adverse Events Involving Therapeutic Alternatives: A Study from the French Spontaneous Reporting Database

IntroductionThe consequences of the withdrawal of marketing authorisation of drugs have mostly been studied considering drug prescription patterns for the therapeutic alternatives of the withdrawn drugs. The potential concomitant changes in the reporting of adverse reactions concerning these alternatives have been studied less often.ObjectiveThe objective of this study was to analyse the changes in the reporting of adverse events (AEs) for therapeutic alternatives after the withdrawal of three medicines (dextropropoxyphene, pioglitazone and tetrazepam) from the market for safety reasons.MethodsThis study was performed using both the French pharmacovigilance database and the Echantillon Généraliste des Bénéficiaires (a random sample of French health insurance affiliates). For dextropropoxyphene, pioglitazone and tetrazepam alternatives, the number and types of case reports were studied for both the year preceding the first official safety warning and the year following the withdrawal. Reporting rates expressed per 10,000 reimbursements (RRReimb) and per 10,000 treated patients (RRPat) were also compared for the two periods.ResultsAfter dextropropoxyphene withdrawal, case reports and reimbursements increased for tramadol (case reports: +23%, reimbursements: +13%) and codeine (case reports: +74%, reimbursements: +47%), RRPat being significantly increased for tramadol (0.92 vs. 1.06, pxa0=xa00.02). After pioglitazone withdrawal, case reports increased for dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides, and glucagon-like peptide 1 (GLP-1) analogues (+84%, +22% and +5%, respectively) and reimbursements (+55, +11 and +50%, respectively); both decreased for sulfonylureas (case reports: −6%, reimbursements: −2%). RRPat increased for DPP-4 inhibitors (1.63 vs. 2.26, pxa0=xa00.008). After tetrazepam withdrawal, case reports increased for diazepam, methocarbamol and thiocolchicoside (+110, +86 and +157%, respectively), as lesser did reimbursements. RRPat increased for diazepam (1.78 vs. 2.41, pxa0=xa00.054) and thiocolchicoside (0.14 vs. 0.24, pxa0=xa00.013).ConclusionFor the three drug withdrawals investigated, the number of case reports involving alternatives increased to a larger extent than the numbers of prescriptions. This could relate to a higher occurrence of AEs in new users of alternatives who switched from the withdrawn medicines or to an increased awareness of possible AEs.

Scientific Uncertainty in the Press: How Newspapers Describe Initial Biomedical Findings:

Newspapers preferentially cover initial biomedical findings although they are often disconfirmed by subsequent studies. We analyzed 426 newspaper articles covering 40 initial biomedical studies associating a risk factor with 12 pathologies and published between 1988 and 2009. Most articles presented the study as initial but only 21% mentioned that it must be confirmed by replication. Headlines of articles with a replication statement were hyped less often than those without. Replication statements have tended to disappear after 2000, whereas hyped headlines have become more frequent. Thus, the public is increasingly poorly informed about the uncertainty inherent in initial biomedical findings.

Power shifts in the regulation of medicines: an inter-field analysis of a French agency

ABSTRACT As in many countries, in France, drug authorization is supposedly carried out by ‘independent’ agencies using ‘evidence-based medicine’. French Health Ministers, however, have recently destabilized this system by intervening directly to remove specific drugs from the market. Drawing upon a study of one such decision concerning antidiabetics, this article refutes an explanation of ministerial intervention in terms of the ‘heroic action’ of politicians. Instead, drawing on concepts from sociology and policy analysis, a generalizable analytical framework is proposed to capture deep shifts in power relations between representatives of four ‘fields’ (medical science, administration, party politics and journalism) which underlie ministerial intervention of this type. Specifically, the claim tested is that power struggles within and between those fields strongly structure actor behavior, but also create contingency. Indeed, in the case studied, these struggles coincided in such a way as to prompt and legitimate ministerial coercion. Rather than perpetuate the illusion of agency independence, social science should therefore shed light upon the intra and inter-field frictions which inevitably occur around the authorization of drugs.

Impact of pioglitazone regulatory withdrawal on antidiabetic drug use and health in diabetic patients

PurposeIn 2011, pioglitazone was withdrawn from the French market owing to a potential risk of bladder cancer. This study aimed at assessing the impact of this pioglitazone withdrawal (PW) considering (i) trends in antidiabetic uses and (ii) changes in hospitalization/death rates in diabetic patients following PW.MethodsWe first considered the general population of the Echantillon Généraliste des Bénéficiaires (EGB), a 1/97th representative sample of the French healthcare insurance system beneficiaries, for the 2010–2014 period. In this, for each non-insulinic antidiabetic drug class, changes within the numbers of monthly supplied drug units for 1000 subjects were studied through times series and Unobserved Component Models. Second, we identified from the EGB a cohort of patients who were delivered a non-insulinic antidiabetic between 01 April 2011 and 01 August 2011 (date of PW). In this, post-withdrawal incidences of all-cause hospitalization and death were compared amongst pioglitazone users and non-users using proportional subdistribution hazards models.ResultsPW was accompanied by an increase in metformin (+xa011.7; 95% CI 1.1–22.3) and glinide (+xa011.0; 95% CI 1.2–20.8) numbers of monthly supplied units for 1000 subjects. No significant change was found for GLP-1 agonists, DPP-4 inhibitors, sulphonylureas or alpha-glucosidase inhibitors. In the cohort of non-insulinic antidiabetic users at the time of PW (1093 pioglitazone users, 17,900 non-users), being a pioglitazone user at PW was not associated with a subsequently higher rate of hospitalization.ConclusionsIf PW was accompanied with significant changes in the use of some antidiabetics, no adverse impact of PW on hospitalization or death rates of diabetic type 2 patients was found.