Henri Bergeron

Inconsistencies among European Union pharmaceutical regulator safety communications: a cross-country comparison

Background The European Medicines Agency (EMA) and national regulators share the responsibility to communicate to healthcare providers postmarketing safety events but little is known about the consistency of this process. We aimed to compare public availability of safety-related communications and drug withdrawals from the EMA and European Union member countries for novel medicines. Methods and Findings We performed a cross-sectional analysis using public Dear Healthcare Professional Communications (DHPCs) for all novel medicines authorized between 2001 and 2010 by the EMA and available for use in France, Netherlands, Spain, and the United Kingdom. Between 2001 and 2010, the EMA approved 185 novel medicines. DHPCs could not be ascertained for the EMA. Among the 4 national regulators, as of April 30, 2013, at least one safety DHPC or withdrawal occurred for 53 (28.6%) medicines, totaling 90 DHPCs and 5 withdrawals. Among these 53 medicines, all 4 national agencies issued at least one communication for 17 (32.1%), three of the four for 25 (47.2%), two of the four for 6 (11.3%), and one of the four for 5 (9.4%). Five drugs were reported to be withdrawn, three by all four countries, one by three and one by two. Among the 95 DHPCs and withdrawals, 20 (21.1%) were issued by all 4 national regulators, 37 (38.9%) by 3 of the 4, 22 (23.2%) by 2 of the 4, and 16 (16.8%) by one. Consistency of making publicly available all identified safety DHPC or withdrawal across regulator pairs varied from 33% to 73% agreement. Conclusions Safety communications were not made publicly available by the EMA. Among the 4 European member countries with national regulators that make DHPCs publicly available since at least 2001, there were substantial inconsistencies in safety communications for novel medicines. The impact of those inconsistencies in terms of public health remains to be determined.

Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

The aim of the study is to describe preapproval safety concerns expressed by the European Medicines Agency (EMA) following regulatory review and to compare those concerns with subsequent issuance of postmarket safety communications.

Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

AIMS Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). METHODS We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMAs 210 day regulatory deadline. RESULTS Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276-406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). CONCLUSIONS Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines.

Politiques publiques et croyances collectives. Analyse socio- historique de la politique française de soins aux toxicomanes de 1970 à 1995

Oft wird geltend gemacht, das sich die lang anhaltende Ablehnung der Professionellen und des Staates in Frankreich gegenuber Substitutionsprogramme unter anderem durch die tiber die Zeit und die Geschichte langsame Entwicklung eines spezifischen Gesundheits-paradigmas erklart. Als Mischung aus Uberlegungen der achtundsechziger Zeit, antipsychiatrisch und psychonalytisch, ist dieses Modell selbst nur wenig offen fur Substitutionsmittel und eine liberale Drogenpolitik. Auch wenn es richtig ist, das dieses Paradigma fur lange Zeit die Konzeptionen der Mehrzahl franzosischer Akteure in bezug auf das was mit Drogen-abhangigen gemacht und nicht gemacht werden soil, bestimmt hat, so scheint es doch wichtig zu verstehen, wie diese Vorstellungen entstanden sind und fur so lange Zeit legitimiert werden konnten, ohne dabei auf vorschnelle Erklarungen einer Blindheit, eines Widerstandes gegenuber Veranderungen oder eines falschen Bewustseins zuruckzugreifen. Unter Verwendung des kognitivistischen Konzepts kollektiver Vorstellungen von Boudon zeigt der Autor, das diejenigen, die in Frankreich mit Drogenpolitik beschaftigt sind, so lange an einen therapeutischen Dispositiv und am normativen Ziel der Abstinenz festhielten, weil sie gute Grtinde dafur hatten zu glauben, was sie geglaubt haben und zu tun, was sie taten.

L’enseignement de la sociologie des organisations

uand et comment l’enseignement de la sociologie des organisations a-t-il debute en France dans les universites, les ecoles, les autres etablissements, en formation initiale et en formation des adultes ? Quelles ont ete les experiences d’enseignement dans les annees 1970 ? Ou en est cet enseignement aujourd’hui ? Quels sont les apports de la sociologie des organisations ?

Drug Addiction: Sociological Aspects

The aim of this article is to relate the history of the principal sociological theories of drug addiction, and in turn, discuss their respective concerns and impact as well as the contributions and failures of these theories in understanding this type of deviant behavior. The emphasis will be put on how sociological theories of drug addiction, especially those grounded in symbolic interaction, labeling, and role theory in the 1950s and 1960s and those, more rationalistic, focused on decision making and the actors choice (in the 1980s and 1990s), have tried to demolish both the psychological predisposition theory (psychologically damaged individual) and the social structural weakness of ‘poor suburbs’ theory and how they have succeeded in drawing a more complex and diversified image of reality concerning drug addicts and drug experiences.