The environments of reproductive and birth defects research in the U.S. and West Germany (c. 1955-1975).

Most historiographies of the crossroads of environmental and reproductive health in 20th century start and end with the case of thalidomide. Despite its global scope, thalidomide today stands for sharp contrasts: in the numbers of victims, in institutional responses to the disaster, and also-more generally-in regulatory approaches to potential risks and national cultures of reproductive justice and disability rights. This paper takes a closer look at two countries that have been seen as emblematic of this divide in regulatory frameworks, despite similarities and interconnections in other areas, such as (pharma)industrial production, science, and robust feminist environmental health movements: the U.S. and West Germany. It argues that thalidomide needs to be historically contextualized within a broad framework of concepts and models of environment from research on exogenous reproductive effects. To do so, it reconstructs what counted as environment in research on reproductive health and birth defects in these two national settings in the postwar decades. It looks at transformations made across multifaceted initiatives, studying collective landscapes and workplaces as potentially dangerous "outer worlds," as well as smaller scale and more individualized environments, i.e., the maternal metabolism, uterus, lifestyle, or social interactions. The article thereby aims to explicate concepts and debates about the environment that influenced later national divisions in politics of science and technology, hinting of the democratic challenges these posed.

"Risk-free rest and sleep:" Jornal do Médico (Portugal) and the thalidomide disaster, 1960-1962. / "Descansar e dormir sem riscos": o Jornal do Médico (Portugal) e o desastre da talidomida, 1960-1962.

This article analyzes the way the Porto-based journal Jornal do Médico reported on the thalidomide disaster. The pages of the publication are researched from the beginning of 1960 to the end of 1962 with the aim of identifying and discussing two interconnected questions: the delay in publishing news on the harmful effects of the drug, which was sold in the country under the brand name Softenon®, and the discursive construction of a lack of accountability on the part of physicians for the phenomenon of medication iatrogenesis.

O artigo analisa como o periódico Jornal do Médico, editado na cidade do Porto, em Portugal, divulgou o desastre da talidomida. A pesquisa percorreu as páginas da fonte desde o início de 1960 até o final de 1962. Aqui, objetivam-se apontar e discutir duas questões interligadas: a morosidade em publicar matérias sobre os efeitos deletérios do medicamento, vendido no país sob a denominação Softenon®, e a construção discursiva da isenção da responsabilidade do médico no fenômeno da iatrogenia medicamentosa.

"Descansar e dormir sem riscos": o Jornal do Médico (Portugal) e o desastre da talidomida, 1960-1962 / "Risk-free rest and sleep: " Jornal do Médico (Portugal) and the thalidomide disaster, 1960-1962

Resumo O artigo analisa como o periódico Jornal do Médico, editado na cidade do Porto, em Portugal, divulgou o desastre da talidomida. A pesquisa percorreu as páginas da fonte desde o início de 1960 até o final de 1962. Aqui, objetivam-se apontar e discutir duas questões interligadas: a morosidade em publicar matérias sobre os efeitos deletérios do medicamento, vendido no país sob a denominação Softenon®, e a construção discursiva da isenção da responsabilidade do médico no fenômeno da iatrogenia medicamentosa.

Abstract This article analyzes the way the Porto-based journal Jornal do Médico reported on the thalidomide disaster. The pages of the publication are researched from the beginning of 1960 to the end of 1962 with the aim of identifying and discussing two interconnected questions: the delay in publishing news on the harmful effects of the drug, which was sold in the country under the brand name Softenon®, and the discursive construction of a lack of accountability on the part of physicians for the phenomenon of medication iatrogenesis.

Pharmaceuticals and modern statecraft in South Africa: the cases of opium, thalidomide and contraception.

This article provides a history of three pharmaceuticals in the making of modern South Africa. Borrowing and adapting Arthur Daemmrich's term 'pharmacopolitics', we examine how forms of pharmaceutical governance became integral to the creation and institutional practices of this state. Through case studies of three medicaments: opium (late 19th to early 20th century), thalidomide (late 1950s to early 1960s) and contraception (1970s to 2010s), we explore the intertwining of pharmaceutical regulation, provision and consumption. Our focus is on the modernist imperative towards the rationalisation of pharmaceutical oversight, as an extension of the state's bureaucratic and ideological objectives, and, importantly, as its obligation. We also explore adaptive and illicit uses of medicines, both by purveyors of pharmaceuticals, and among consumers. The historical sweep of our study allows for an analysis of continuities and changes in pharmaceutical governance. The focus on South Africa highlights how the concept of pharmacopolitics can usefully be extended to transnational-as well as local-medical histories. Through the diversity of our sources, and the breadth of their chronology, we aim to historicise modern pharmaceutical practices in South Africa, from the late colonial era to the Post-Apartheid present.

Evidence of mechanism in the evaluation of streptomycin and thalidomide.

This paper considers what evidence is needed to establish the effectiveness and safety of a drug therapy. The claim that A cures D is a particular case of a causal claim in medicine. So the paper begins with a general analysis of the evidence for causal claims in medicine. Such evidence is divided into two types: statistical evidence and evidence of mechanism. These are further divided into observational and interventional, producing a 2x2 classification. It is shown that historically there have different assessments of the importance of these different types of evidence. Evidence-based medicine (EBM) puts forward the thesis that claims of the form 'A cures D without harming the patient' can be established using only randomized controlled trials or RCTs. This thesis of EBM is criticized by considering two historical examples: streptomycin and thalidomide. Generalizing from these, it is claimed that the effectiveness and safety of a drug therapy can only be established by using both statistical evidence and evidence of mechanism. This is a specific instance of the Russo-Williamson thesis.

A tragédia da talidomida: a luta pelos direitos das vítimas e por melhor regulação de medicamentos / The thalidomide tragedy: the struggle for victims' rights and improved pharmaceutical regulation

Resumo A tragédia da talidomida, no final dos anos 1950, constituiu um divisor de águas na regulação de medicamentos. Novos usos da droga estão sendo pesquisados e implementados atualmente. O artigo revisita a história da talidomida e seus desdobramentos no plano regulatório e dos direitos das vítimas no Brasil, com base em revisão de literatura, análise documental e reportes de jornais. Destaca que os eventos evidenciaram a carência de normas fortes para o uso seguro de medicamentos e mostra que a transformação dos acontecimentos em um problema público, mediante sua veiculação na mídia, e a crescente mobilização das vítimas foram forças essenciais que pressionaram por uma regulação de medicamentos mais efetiva.

Abstract The thalidomide tragedy in the late 1950s was a watershed moment for pharmaceutical regulation. New uses for this medication are being researched and implemented today. This article revisits the history of thalidomide and its consequences for regulation and for victims' rights in Brazil, based on a literature review, documentary analysis, and newspaper reports. The events highlighted herein show the lack of strong standards for safe medication use, as well as how the tragedy was transformed into a public problem through its divulgation in the press; the article also shows that the increasing mobilization of victims was essential in pushing for more effective drug regulations.

[Not Available]. / Un médicament "monstrueux": débats publics et couverture médiatique de la tragédie de la thalidomide au Canada, 1961-1963.

This article focuses on the thalidomide tragedy that occurred in Canada in 1962. Through the study of various primary sources, including letters sent by citizens to the federal Minister of Health and newspaper coverage of the tragedy, we provide an analysis of the public debates provoked by babies born with phocomelia in order to better assess the conception Quebec and Canadian societies had of disabled persons at the beginning of the 1960s. Inspired by the French philosopher Marie-Claire Cagnolo's classification scheme of the "logics" that characterized the treatment of disabled persons through history, the study concludes that a "separatist logic of elimination" clearly arose, while a "paternalistic logic of reparation" also began to appear. A "societal logic of integration", however, did not emerge, as concern was limited to the fate of thalidomide babies, rather than that of all disabled children.

The Curious Case of Thalidomide and the Absent Eugenic Clause in Canada's Amended Abortion Law of 1969.

This essay traces the role of the drug thalidomide in the reform of Canadian abortion law during the late 1960s. Like elsewhere in the British Commonwealth, discussion of the "thalidomide disaster" of the early 1960s intensified leading up to the debates that culminated in the 1969 amendment to Canadian abortion law. Although thalidomide was a rallying point for advocates of eugenic abortion, a majority of Canadian MPs, unlike their British and Commonwealth counterparts, rejected this argument. Widespread public and political considerations of the thalidomide tragedy were thus unable to inspire support for a eugenic clause in Canada's new abortion law, in spite of the nation's infamous eugenic past.

"New drug" designations for new therapeutic entities: new active substance, new chemical entity, new biological entity, new molecular entity.

This Perspective addresses ambiguities in designations of "new drugs" intended as new therapeutic entities (NTEs). Designation of an NTE as a new drug is significant, as it may confer regulatory exclusivity, an important incentive for development of novel compounds. Such designations differ between jurisdictions according to their drug laws and drug regulations. Chemical, biological, and innovative drugs are addressed in turn. The terms new chemical entity (NCE), new molecular entity (NME), new active substance (NAS), and new biological entity (NBE) as applied in worldwide jurisdictions are clarified. Differences between them are explored through case studies showing why new drugs have different periods of exclusivity in different jurisdictions or none at all. Finally, this Perspective recommends that in future, for the purpose of new drug compilations, NME is used for a new chemical drug, NBE for a new biological drug, and the combined designation NTE should refer to either an NME or an NBE.

Professor David Poswillo CBE (1927-2003): Skilled oral and maxillofacial surgeon, influential scientist, teacher and adviser.

David Poswillo trained at Otago University Dental School, Dunedin, New Zealand (BDS) and the Royal College of Surgeons of England (FDSRCS). His great interest became the genesis and repair of cleft lip and palate and, in addition to clinical work, he undertook an experimental study of the embryology of cleft palate in pregnant rats exposed to three teratogenic agents. The microscopic work was carried out in his garden shed in Christchurch. His groundbreaking work on amniotic puncture at a critical period came to international notice and he was given the first Chair in Teratology of the Royal College of Surgeons. In experimental studies he showed that thalidomide induced focal haemorrhage in the developing embryo. Poswillo was also Consultant Oral Surgeon at Queen Victoria Hospital, East Grinstead and his skills as surgeon and teacher attracted numerous trainee surgeons. He was Professor of Oral Surgery in Adelaide and then in London. Poswillo was Chairman of two advisory committees whose lucid reports on anaesthesia, sedation and resuscitation in dentistry (Poswillo Report) and on tobacco and health were far-reaching and influential. David Poswillo had immense energy and enthusiasm and is remembered by many for his personal interest and stimulating guidance.

'Something there is that doesn't love a wall': histories of the placental barrier.

This article appraises the late twentieth century maxim that prior to thalidomide's clarion call in 1961, a generic "we" believed that the fetus was protected from external insult by the placental barrier. Complicating this truism, we demonstrate that the placenta was, since early in the twentieth century, conceived of as a site of constant passage of entities both necessary to, and dangerous for, fetal development. Moving between evidence from specialist journals, obstetrics textbooks, and pregnancy advice manuals, we argue that the placental barrier writ large only emerged as an explicit actor after the medical community was disillusioned with it: it became something that does not exist. The article proposes that the nostalgia for a barrier lost constructs the modern-day fetus as more exposed and vulnerable than if "we" had never imagined this protection in the first place. The rhetorical shorthand of the erstwhile placental barrier has both deflected more nuanced accounts of the thalidomide story and contributed to the increasing surveillance of pregnant women's behavior, particularly in late twentieth century North America.

Concern for truth: driving defensively when confronting a zombie epidemic.

The newly approved drug Diclegis(®), indicated for the treatment of nausea and vomiting associated with pregnancy, has a very interesting background story going back more than 50 years, in which science, celebrity individuals, the media, and the courts crossed paths. The story illustrates how concepts of truth, evidence, objectivity, and disinterested inquiry can become distorted in various ways, and this is especially relevant and prevalent in today's media environment of cable television, talk radio, and especially the Internet.