Advertisement
SYMPOSIUM: RISK, INNOVATION AND IGNORANCE PRODUCTION Original Article| Volume 14, P75-86, March 01, 2022

The Duogynon controversy and ignorance production in post-thalidomide West Germany

Open AccessPublished:October 19, 2021DOI:https://doi.org/10.1016/j.rbms.2021.09.003

      Abstract

      This article examines the West German controversy over Duogynon, a ‘hormone pregnancy test’ and the drug at the centre of the first major, international debate over iatrogenic birth defects in the post-thalidomide era. It recovers an asymmetrical power struggle over the uneven distribution of biomedical knowledge and ignorance (about teratogenic risk) that pitted parent-activists, whistleblowers and investigative journalists against industrialists, scientific experts and government officials. It sheds new light on the nexus of reproduction, disability, epidemiology and health activism in West Germany. In addition, it begins to recover an internationally influential discourse that, in the post-thalidomide world, seems to have resuscitated antenatal drug use as safe until proven harmful.

      Keywords

      Between thalidomide and diethylstilbestrol

      Between 1950 and the 1980s, millions of women worldwide found out whether or not they were pregnant by swallowing tablets or receiving injections. Duogynon, the first ‘hormone pregnancy test’ (HPT), was developed in the late 1940s by the West-Berlin-based pharmaceutical company Schering AG (acquired by Bayer in 2006). As a diagnostic drug, it ruled out gestation by inducing uterine bleeding (a ‘negative’ result); no bleeding confirmed pregnancy. When Duogynon debuted in the Federal Republic of Germany (FRG) in 1950, home pregnancy tests did not yet exist. Pregnancy diagnosis involved injecting laboratory animals – usually frogs – with a woman’s urine (
      • Olszynko-Gryn J.
      Pregnancy testing with frogs.
      ). At a time when laboratories were struggling to meet increasing demand (
      • Olszynko-Gryn J.
      • Bjørvik E.
      • Weßel M.
      • Jülich S.
      • Jean C.
      A historical argument for regulatory failure in the case of Primodos and other hormone pregnancy tests.
      ), Schering marketed Duogynon as a cheaper and more convenient alternative to the expensive and cumbersome ‘frog test’ (Froschtest). Other companies followed suit, and a range of HPTs were marketed internationally (
      • Olszynko-Gryn J.
      Pregnancy Testing in Britain, c.1900–67: Laboratories, Animals and Demand from Doctors, Patients and Consumers.
      ), including through exclusive licencing agreements with Schering (

      Olszynko-Gryn, J., 2016. Risky hormones, birth defects and the business of pregnancy testing, Part 1. Perceptions of Pregnancy (22 Nov.), https://perceptionsofpregnancy.com/2016/11/22/risky-hormones-birth-defects-and-the-business-of-pregnancy-testing-pt-i/

      ).
      Schering was one of a handful of large companies with in-house research laboratories that, in the interwar period, carved out a gynaecological market for industrial sex hormones (
      • Gaudillière J.P.
      Sex hormones, pharmacy and the reproductive sciences.
      ). Women’s bodies were increasingly ‘hormonalized’ as proprietary molecules proliferated in the medical management of menstruation, pregnancy and menopause (
      • Malich L.
      Die Gefühle der Schwangeren: Eine Geschichte somatischer Emotionalität (1780–2010).
      ,
      • Oudshoorn N.
      Beyond the Natural Body: An Archaeology of Sex Hormones.
      ). Duogynon contained norethisterone acetate, a synthetic progestogen used to prevent miscarriage, and ethinyl estradiol, a synthetic oestrogen used to treat symptoms of menopause. It was marketed simultaneously as a treatment for amenorrhoea (the absence of menstruation) and as a diagnostic test for early pregnancy. In 1961, Schering re-combined the same hormones in Anovlar, Europe’s first contraceptive pill.
      The fact that Duogynon and Anovlar differed in dosage, regimen and indication but contained the same ingredients would link HPTs and oral contraception in the first major international debate over iatrogenic birth defects of the post-thalidomide era. The debate, which still resonates today, focused on the use and regulation of synthetic sex hormones in early pregnancy. It was sparked on 7 October 1967 by a brief report in the prestigious journal Nature (
      • Gal I.
      • Kirman B.
      • Stern J.
      Hormonal pregnancy tests and congenital malformation.
      ). Lead author Isabel Gal, a paediatrician at Queen Mary’s Hospital for Children in Surrey, near London, UK, warned that Primodos – as Duogynon was called in Britain – might be causing spina bifida (a severe neural tube defect). She also implicated Amenorone Forte (Roussel Laboratories), the second most popular HPT in Britain, and Norlestrin (Parke-Davis), a contraceptive pill that, in the event of conception due to forgetfulness or some other reason, would likewise expose the fetus to norethisterone acetate and ethinyl estradiol (
      • Marks L.
      Sexual Chemistry: A History of the Contraceptive Pill.
      ).
      Like ‘the pill’ and other reproductive technologies, Duogynon was not one thing. Rather, the drug came in a variety of forms: ampoules (1950–1978); disposable syringes (1956–1980); and tablets (1958–1973). Tablets with a higher dose of norethisterone acetate became available in 1962. Sales figures indicate a turnover of 225,000 DM in 1952 (

      Schering, 1982. Produkthistorie Pharma: Duogynon, p. 1. Pharma Präparate, Duogynon XC 1.38/01, Schering Archives, Berlin.

      ). Twenty-five years later, Schering reportedly sold around 1.2 million units (ampoules and tablets) annually, valued at 3.3 million DM (
      • Anon
      Teurer Rizinus.
      ,
      • Anon
      Gefährlicher Test.
      ,
      • Anon
      Arzneimittel – Ein Gefährlicher Test.
      ). By then, cheap, reliable laboratory test kits as well as commercial home pregnancy tests had become available (
      • Olszynko-Gryn J.
      Predictor: the first home pregnancy test.
      ), making it more difficult to justify the continued use of HPTs, and easier for Schering to remove Duogynon from the West German market in 1981. However, it did so only after sustained public pressure and legal action brought against the company by the young parents of ‘Duogynon-damaged children’.
      HPTs faded from view in the 1980s, and there the story might have ended. Recently, however, a reinvigorated campaign – led by parents and their now-adult children in Britain and Germany – has once again drawn in journalists, scientists, politicians and lawyers (
      • Brown S.
      • Fraga L.R.
      • Cameron G.
      • Erskine L.
      • Vargesson N.
      The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebra fish embryos.
      ,
      • Cumberlege J.
      First Do No Harm: The Report of the Independent Medicines and Medical Devices Safety Review.
      • Bundestag Deutscher
      Verhandlungen des Deutschen Bundestags: Stand der Aufklärung zur Rolle deutscher Behörden hinsichtlich der Registrierung und Pharmakovigilanz von Duogynon. Drucksache 19/28270.
      ,
      • Farrell J.
      • Lane L.
      Primodos: The Secret Drug Scandal.
      ,
      • Farrell J.
      • Lane L.
      Bitter Pill: Primodos.
      ,
      • Heneghan C.
      • Aronson J.K.
      Sodium valproate: who knew what and when? Cumulative meta-analysis gives extra insights.
      ,
      • Heneghan C.
      • Aronson J.
      Forgotten Primodos story and the roles of general practitioners.
      ,
      • Stücken C.
      Der Vertuschte Skandal: Ein Pharmakonzern und sein Hormonpräparat.
      ,
      • Henegahn C.
      • Aronson J.
      • Spencer E.
      • Holman B.
      • Mahtani K.
      • Perera R.
      • Onakpoya I.
      Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis.
      ). This time round, there is a huge amount of archival evidence to sift through, and historians have also become involved (
      • Claes T.
      L’autre scandale ‘Softenon’, tombé dans l’oubli.
      ,
      • Olszynko-Gryn J.
      • Bjørvik E.
      • Weßel M.
      • Jülich S.
      • Jean C.
      A historical argument for regulatory failure in the case of Primodos and other hormone pregnancy tests.
      ,
      • Weßel M.
      Primodos – Hormonaalinen raskaustestaus Suomessa.
      ). So far, we know that some European countries – notably Norway, where a more precautionary attitude prevailed – took regulatory action earlier than others. We also know that in 1978, at a crucial juncture in the British debate, the UK Minister of Health used the negative results of a large West German study to block British calls for a public inquiry into the teratogenicity of HPTs (
      • Olszynko-Gryn J.
      • Bjørvik E.
      • Weßel M.
      • Jülich S.
      • Jean C.
      A historical argument for regulatory failure in the case of Primodos and other hormone pregnancy tests.
      ). However, although HPTs originated in West Germany and remained on the market there for longer than anywhere else in Europe, we do not yet have a history of Duogynon in the FRG. Nor do we know much about the West German study that figured so decisively in the British debate.
      This article examines the Duogynon controversy in post-thalidomide West Germany. As a contribution to the historical study of ignorance (
      • Oreskes N.
      • Conway E.M.
      Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming.
      ,
      • Proctor R.N.
      • Schiebinger L.
      Agnotology: The Making and Unmaking of Ignorance.
      ,
      • Proctor R.N.
      Golden Holocaust: Origins of the Cigarette Catastrophe and the Case for Abolition.
      ,
      • Tuana N.
      The Speculum of Ignorance: The Women’s Health Movement and Epistemologies of Ignorance.
      ), it explores an asymmetrical power struggle over the uneven distribution of biomedical knowledge – and structured absences of knowledge – about iatrogenic birth defects. It also begins to connect the dots between thalidomide and diethylstilbestrol (DES), the second most infamous teratogenic drug after thalidomide. The first synthetic oestrogen, DES, gained notoriety in the 1970s as a transplacental carcinogen. It became a focal point of health activism and has attracted considerable historical attention, especially for the USA and France (
      • Bell S.
      DES Daughters: Embodied Knowledge, and the Transformation of Women’s Health Politics in the Late Twentieth Century.
      ,
      • Cody P.
      DES Voices: From Anger to Action.
      ,
      • Fillion E.
      • Torny D.
      Un précédent manqué: le Distilbène® et les perturbateurs endocriniens. Contribution à une sociologie de l’ignorance.
      ,
      • Fillion E.
      • Torny D.
      ‘Like mother, like daughter, like grand-daughter...’: Transgenerational ignorance engendered by a defective reproductive health technology.
      ,
      • Gaudillère J.P.
      DES, cancer and endocrine perturbation: ways of regulating, chemical risks and public expertise in the United States.
      ,
      • Langston N.
      Toxic Bodies: Hormone Disruptors and the Legacy of DES.
      ). The Duogynon controversy, we argue, was pivotal in a larger and more international debate that centred first on thalidomide, then on synthetic sex hormones (including HPTs and DES), and later on a succession of other drugs including anticonvulsants and acne medications (

      Ferguson, I., 2021. A Face to Die for: Acne, Dermatology, and the Quest for Perfect Skin in Britain and the United States, c.1800–present. PhD thesis. University of Strathclyde, Glasgow.

      ,
      • Green M.D.
      Bendectin and Birth defects: The Challenges of Mass Toxic Substances Litigation.
      ,
      • Heneghan C.
      • Aronson J.K.
      Sodium valproate: who knew what and when? Cumulative meta-analysis gives extra insights.
      ,
      • Martin M.
      Dépakine, le scandale: Je ne pouvais pas me taire.
      ,
      • Méréo F.
      Les Résistantes: 12 femmes qui font bouger la médicine.
      ,
      • Sanders J.
      Bendectin on Trial: A Study of Mass Tort Litigation.
      ,
      • Timmermans S.
      • Leiter V.
      The redemption of thalidomide: standardizing the risk of birth defects.
      ). Reconstructing it, as we begin to do in this article, will enrich the historical understanding of (debates over) antenatal drug use and teratogenic risk in the post-thalidomide world.

      Teratology after thalidomide

      The thalidomide disaster (1957–1961) structured all subsequent debates over iatrogenic birth defects, starting with the Duogynon controversy. Thalidomide was developed in the 1950s as a safer alternative to barbiturate sedatives by Chemie Grünenthal, a family-run company that made penicillin for the West German market. It debuted in West Germany in 1957 as Contergan, an over-the-counter treatment for morning sickness and all-round ‘wonder drug’. By the time it was discontinued, in 1961, it had damaged the limbs, face, eyes, ears, genitals and internal organs of some 5000 West German children, many of whom died young. The worldwide total of children born with malformations was at least 10,000, with many more deaths in utero (
      • Johnson M.
      • Stokes R.
      • Arndt T.
      The Thalidomide Catastrophe: How It Happened, Who Was Responsible and Why the Search for Justice Continues After More Than Six Decades.
      ,
      • Parle J.
      • Wimmelbücker L.
      ‘These are the medicines that “make” monsters’: thalidomide in southern Africa, 1958–1962.
      ,
      • Vargesson N.
      Thalidomide-induced teratogenesis: history and mechanisms.
      ).
      The thalidomide disaster shocked a young republic emerging from an extended period of safety and prosperity. It was exacerbated in the FRG by high consumption of pharmaceuticals, lack of information about adverse effects, absence of effective drug laws or regulatory oversight, and poor communication between scientists and clinicians. West Germany was home to the world’s second largest pharmaceutical industry (after the USA), a booming domestic market for prescription drugs, and an industry-friendly government that held the medical profession and pharmaceutical industry in high regard (
      • Daemmrich A.
      A tale of two experts: thalidomide and political engagement in the United States and West Germany.
      ,
      • Kessel N.
      Contergan in der Konsumgesellschaft: Wissen und Nichtwissen über Arzneimittelverbrauch in der Bundesrepublik, 1955–1962.
      ,
      • Kirk B.
      Der Contergan-Fall. Eine unvermeidbare Arzneimittelkatastrophe?: Zur Geschichte des Arzneistoffs Thalidomid.
      ,
      • Lenhard-Schramm N.
      Das Land Nordrhein-Westfalen und der Contergan-Skandal: Gesundheitsaufsicht und Strafjustiz in den ‘Langen Sechziger Jahren’.
      ,
      • Lenhard-Schramm N.
      Contergan und das Arnzeimittelrecht.
      ). From the late 1940s to the early 1970s, nation-building was synonymous with the West German ‘economic miracle’ (

      Uekötter, F., 2015. Deutschland in Grün: eine zwiespältige Erfolgsgeschichte. Vandenhoeck & Ruprecht, Göttingen.

      ). The pharmaceutical industry, alongside the chemical and automotive industries, stood for national regeneration, wealth and trust. Thalidomide, however, precipitated a crisis of faith in medical authority and damaged patients’ faith in drug safety. In particular, those with access to international news sources came to suspect experts and regulators of routinely downplaying harm, such as the risk (to women, not fetuses) of breast cancer and fatal blood clots with Anovlar (

      Kessel, N., 2019. La perte de confiance des citoyens. Les risques médicamenteux pendant la crise de la thalidomide en Allemagne de l’Ouest, 1962. Anthropol. santé 19, doi: 10.4000/anthropologiesante.5335.

      ).
      Starting in the early 20th century, a number of environmental factors, including maternal infection, fetal anoxia, malnutrition, radiation, chemicals and pharmaceuticals, came under investigation as possibly teratogenic (
      • Dron H.A.
      Teratology Transformed: Uncertainty, Knowledge, and Conflict over Environmental Etiologies of Birth Defects in Midcentury America.
      ,
      • Kalter H.
      Teratology in the 20th century: Environmental causes of congenital malformations in humans and how they were established.
      ). Suspicion fell on the synthetic sex hormones, with a consensus forming in the 1950s that progestogens such as norethisterone acetate could ‘masculinize’ the female fetus (
      • Dubowitz V.
      Virilisation and malformation of a female infant.
      ,
      • Schardein J.L.
      Congenital abnormalities and hormones during pregnancy: a clinical review.
      ,
      • Zander J.
      • Müller H.A.
      Über die Methylandrostendiolbehandlung während einer Schwangerschaft.
      ). Duogynon was first discussed as a possible teratogen by an expert commission of the Düsseldorf health administration following the withdrawal of thalidomide (T. Arndt quoted in ). However, despite the known risk of masculinization, sex hormones (including DES) were generally regarded as clinically safe (
      • Langston N.
      Toxic Bodies: Hormone Disruptors and the Legacy of DES.
      ). As with other ‘undone sciences’ (
      • Frickel S.
      • Gibbon S.
      • Howard J.
      • Kempner J.
      • Ottinger G.
      • Hess D.
      Undone science: charting social movement and civil society challenges to research agenda setting.
      ), teratology, the science of birth defects, was allowed to languish despite (or because of) interest from social movements and civil society.
      The already insecure status of teratology in the early FRG was further weakened by a post-war political agenda that favoured industrial research and development, including projects connected to nuclear power, and tended to side-line research into the environmental causes of congenital malformation (
      • Kirk B.
      Der Contergan-Fall. Eine unvermeidbare Arzneimittelkatastrophe?: Zur Geschichte des Arzneistoffs Thalidomid.
      ). Nor did the continuation of eugenic approaches to reproduction and more internalist or ‘hereditary’ explanations for disability after 1945 favour teratology as a science worthy of investment (
      • Herzog D.
      Unlearning Eugenics: Sexuality, Reproduction, and Disability in Post-Nazi Europe.
      ,
      • Rübsamen H.
      • Leder O.
      Zu den Ursachen menschlicher Mißbildungen.
      ). Infectious disease and malnutrition, not drugs, dominated the post-war discourse in paediatrics, the clinical science most directly concerned with the immediate effects of congenital malformation. This changed only as a result of thalidomide, and the introduction of a more social approach to paediatrics from the mid 1960s (
      • Spranger J.
      Grundzüge der Pädiatrie in Westdeutschland.
      ).

      The German research foundation study

      In the aftermath of thalidomide, individuals and families formed interest groups to challenge a status quo that perpetuated ignorance by keeping iatrogenic birth defects off biomedical research agendas (
      • Nemec B.
      • Moser G.
      Counselling, Risk and Prevention in Human Genetic Early Diagnosis in the Federal Republic of Germany.
      ,

      Osten, P., 2011. Contergan-Skandal: Verstümmelt durch eine Arznei. Frankfurter Rundschau (26 Nov.), 22–23.

      ). Decision makers in politics, biomedicine and industry responded by agreeing to spend 21 million DM on a prospective clinical study on the ‘course of pregnancy and child development’ (
      • DFG
      Bericht der DFG über das Projekt Schwangerschaftsverlauf und Kindesentwicklung.
      ,
      • DFG
      Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
      ). Coordinated by the German Research Foundation (DFG), the multi-site, computerized study was exemplary of Cold War ‘big data’ projects (
      ). It adapted the influential ‘risk factor’ model of epidemiology that had been pioneered in the USA in the 1950s (
      • Patel S.
      Methods and management: NIH administrators, federal oversight, and the Framingham Heart Study.
      ,
      • Timmerman C.
      Appropriating risk factors: The reception of an American approach to chronic disease in the two German states, c. 1950–1990.
      ). In addition, to generate practical knowledge about teratogenic risk factors, including drugs, it would monitor no fewer than 14,800 women and their children between 1964 and 1973.
      DFG selected Siegfried Koller, formerly a leading Nazi-era biostatistician, to co-design the study and handle the patient data it would generate (
      • Aly G.
      • Roth K.H.
      The Nazi Census: Identification and Control in the Third Reich.
      ,
      • Schappacher N.
      • Oehler-Klein S.
      Siegfried Koller und die neuen Herausforderungen der Statistik im Nationalsozialismus.
      ). DFG also coordinated data collection at participating gynaecology and children’s clinics around West Germany, in cooperation with pharmaceutical companies and consulting institutions, including the US National Institutes of Health (NIH) and the World Health Organization. Gynaecologists collected information about maternal serum and hormone levels, general living and work conditions, diet and drinking habits, medication and vitamin consumption, household and garden chemicals, and other socio-economic and environmental factors. Paediatricians collected health data on newborns and toddlers (up to the end of the third year of life). Pathologists carried out cytogenetic examinations of stillborn embryos and placentas, as well as post-mortem autopsies of children who died before their second birthday. Koller used these datasets to investigate correlations between maternal conditions, on the one hand, and infant and child health, on the other.
      The DFG study was modelled on the NIH-funded Collaborative Perinatal Project (1959–1965), which itself had looked to earlier British cohort studies (
      • Hardy J.B.
      The collaborative perinatal project: lessons and legacy.
      ). Part of a broader trend that promoted biostatistics centrally in US health research (
      • Patel S.
      The benevolent tyranny of biostatistics: Public administration and the promotion of biostatistics at the National Institutes of Health, 1946–1970.
      ), the NIH project collected data on over 55,000 pregnant mothers and their children at 12 sites across the USA. It generated computer tapes equivalent to 6 million punched cards (
      • Niswander K.R.
      • Gordon M.
      The Women and their Pregnancies: The Collaborative Perinatal Study of the National Institute of Neurological Diseases and Stroke.
      ), and hundreds of publications over a period of decades (
      • Broman S.H.
      The Collaborative Perinatal Project: an overview.
      ). It identified, amongst other findings, a link between maternal smoking and ‘cot death’ (sudden infant death syndrome) (
      • Klebanoff M.A.
      The Collaborative Perinatal Project: A 50-year retrospective.
      ). The DFG study similarly advised against the consumption of alcohol, cigarettes and (unspecified) medications in pregnancy, and recommended a general expansion of antenatal surveillance ‘from the beginning to the end of pregnancy’ (
      • DFG
      Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
      ,
      • Oakley A.
      The Captured Womb: A History of the Medical Care of Pregnant Women.
      ). It also produced a general list of ‘dangers to women who elude a sensible lifestyle’ (
      • DFG
      Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
      ). Neither the NIH project nor the DFG study disclosed any new teratogenic drugs.
      From 1964, however, the DFG study group had discussed the possible teratogenic risk of Duogynon in light of an observed correlation with birth defects (
      • DFG
      Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
      ). Individual researchers on the project warned against the antenatal use of sex hormones (
      • Hartl H.
      Welche Medikamente sollen in der Schwangerschaft nicht gegeben werden?.
      ,
      • Döring G.
      Empfängnisverhütung: Ein Leitfaden für Ärzte und Studenten.
      ). However, the concluding remarks of the report omitted these concerns (
      • DFG
      Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
      ). Others, meanwhile, remarked on methodological issues that seemed to compromise the results of the study (
      • DFG
      Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
      ).
      For one thing, the analysis excluded women with ‘existing gynaecological illnesses’ (a rather broad category) and those who continued to take prescription medications in pregnancy. This accounted for 59% of pregnancies, of which a large number involved the use of an HPT (
      • DFG
      Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
      ). For another, 30% of the pregnancies were monitored only after 12 weeks of gestation (
      • DFG
      Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
      ). Many clinical reports ‘could not be accurately gathered’ (
      • DFG
      Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
      ), so researchers instead relied on maternal memories (
      • DFG
      Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
      ). Finally, Koller and the statisticians who processed the data explained several of the observed ‘associations’ not as causal relations but as ‘pseudo-correlations’ (
      • DFG
      Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
      ). For example, pregnant women who took hormones or tranquilizers in early pregnancy showed a higher risk of early miscarriage. However, because the pharmaceuticals were administered to treat ‘another risk’ (‘uterine bleeding’ or ‘impending miscarriage’), the correlation was interpreted as a ‘logical association’ and the drugs were not implicated as a risk factor (
      • DFG
      Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
      ).
      Post-thalidomide cultures of antenatal drug use have not been examined historically for any nation. Despite the shock of thalidomide, antenatal prescribing and self-medicating practices seemed to persist more or less unchanged well into the 1970s (
      • Wicklund S.
      Special report: drugs for two in pregnancy.
      ). In Britain, for example, a landmark report on ‘injuries to unborn children’ in 1974 found that 82% of pregnant women consumed prescription drugs and 65% self-medicated (
      • Law Commission
      Report on Injuries to Unborn Children.
      ). The picture is similar in West Germany, where Koller reported that 75% of pregnant women surveyed for the DFG study had used medication in the first trimester alone, with ‘female sex hormone’ (without further specification) as the largest drug category (
      • Koller S.
      Risikofaktoren der Schwangerschaft: Auswertung von 7870 Schwangerschaften der Prospektiven Untersuchungsreihe ‘Schwangerschaftsverlauf Und Kindesentwicklung’ der Deutschen Forschungsgemeinschaft.
      ). As such, it is surprising that his final report devoted only six of 355 pages to ‘medication’ (
      • Koller S.
      Risikofaktoren der Schwangerschaft: Auswertung von 7870 Schwangerschaften der Prospektiven Untersuchungsreihe ‘Schwangerschaftsverlauf Und Kindesentwicklung’ der Deutschen Forschungsgemeinschaft.
      ). Also unclear is why the study failed to account for the ‘mode’, ‘dose’, ‘amount’ or ‘timing’ of the administration of medication (
      • Koller S.
      Risikofaktoren der Schwangerschaft: Auswertung von 7870 Schwangerschaften der Prospektiven Untersuchungsreihe ‘Schwangerschaftsverlauf Und Kindesentwicklung’ der Deutschen Forschungsgemeinschaft.
      ), despite a consensus that these were key factors in the teratogenicity of drugs (

      Grebe, H., 1955. Übertoxische Fruchtschädigungen. Der Landarzt 31, 123–26

      ,
      • Kalter H.
      Teratology in the 20th century: Environmental causes of congenital malformations in humans and how they were established.
      ,
      • Rageth S.
      Medikamentöse Fruchtschäden in der Schwangerschaft.
      ). For a project motivated by thalidomide, it was remarkably incurious about medicines.

      Blowing the whistle on Schering

      Koller and his colleagues on the DFG study communicated its null results, without comment on conspicuous absences or methodological issues, well into the 1980s (
      • Degenhardt K.H.
      Schwangerschaftsverlauf und Kindesentwicklung: Ein überregionales Prospektives Forschungsprojekt.
      ,

      Koller, S., 1972. Die Kooperativ-Studie ‘Schwangerschaftsverlauf Und Kindesentwicklung’, in: Saling, E., Dudenhausen, J.W. (Eds.), Perinatale Medizin. Georg Thieme, Stuttgart, pp.

      ,
      • Koller S.
      The German Collaborative Study on Pregnancy Course and Child-Development.
      ,
      • Koller S.
      Risikofaktoren der Schwangerschaft: Auswertung von 7870 Schwangerschaften der Prospektiven Untersuchungsreihe ‘Schwangerschaftsverlauf Und Kindesentwicklung’ der Deutschen Forschungsgemeinschaft.
      ,
      • Michaelis J.
      • Michaelis H.
      • Glück E.
      • Koller S.
      Prospective study of suspected associations between certain drugs administered during early pregnancy and congenital malformations.
      ). Others, however, took a more critical approach. Soon after the publication of Isabel Gal’s report in Nature in 1967, Ulrich Moebius, an employee of Schering Berlin, defected to become West Germany’s first pharma-critical activist. From 1963 to 1966, the trained medical doctor had recommended Duogynon to gynaecologists as a sales agent in Austria, Ireland and Switzerland. Then, in 1967, he learned about potential risks from the British debate and also saw that his colleagues ‘suspected the risks […] but denied in public that they did’ (quoted in

      Haarhoff, H., 2016. Der Fall Duogynon: Wer sich nicht einschüchtern ließ. Die Tageszeitung, 28 Jan. 2016. https://taz.de/Der-Fall-Duogynon/!5269859.

      ). The Contergan trial (1968–1970), a highly mediatized criminal procedure against Grünenthal employees, kept the risk of iatrogenic birth defects in the public eye long after thalidomide had been discontinued (
      • Bösl E.
      The Contergan Scandal: Media, Medicine, and Thalidomide in 1960s West Germany.
      ,
      • Steinmetz W.
      Ungewollte Politisierung durch die Medien? Die Contergan-Affäre.
      ,

      von Schwerin, A., 2009. Die Contergan-Bombe. Der Arzneimittelskandal und die neue risikoepistemische Ordnung der Massenkonsumgesellschaft, in: Eschenbruch, N. (Ed.), Arzneimittel des 20. Jahrhunderts: Historische Skizzen von Lebertran bis Contergan. Transcript-Verlag, Bielefeld, pp. 255–282.

      ). Shortly after it ended, with a settlement and a verdict of not guilty, Moebius founded the surveillance initiative ‘Arzneimittelradar’ (‘Drug Radar’), and the journal Arznei-Telegramm.
      Moebius worked to democratize biomedical knowledge that, as he saw it, paternalistic experts, corporations and regulators intentionally withheld from patients and consumers, to the detriment of public health. He published the first German warning against HPTs in Arznei-Telegramm in 1971 (
      • Moebius U.
      ). However, his interventions remained largely unnoticed until 1977, when Der Spiegel, a leading weekly news magazine known for investigative journalism and breaking scandals, covered HPTs as part of a series of feature articles on the health risks associated with oral contraception (

      Anon., 1975. Nach Pille und Sexueller Befreiung. Die neuen Krankheiten. Der Spiegel 17, Cover Page.

      ,

      Anon., 1977b. Überdruß an der Pille. Der Spiegel 6, Cover Page.

      ). Contributing to a public debate sparked by emerging feminist concerns with women’s health (

      Brot und Rosen, 1972. Frauenhandbuch Nr. 1: Abtreibung und Verhütungsmittel. Brot und Rosen, Berlin

      ), the magazine belatedly publicized the warnings of Gal and Moebius, and also alleged that the German whistleblower had been silenced for years (
      • Anon
      Teurer Rizinus.
      ).
      In contrast to the federal-government-centred approach favoured by the USA, the FRG vested pharma-regulatory authority in the medical profession and its self-governing associations (
      • Daemmrich A.
      A tale of two experts: thalidomide and political engagement in the United States and West Germany.
      ,
      • Daemmrich A.
      Pharmacopolitics: Drug Regulation in the United States and West Germany.
      ). In the Contergan trial, the Federal Ministry of the Interior cooperated with medical experts to control the flow of information, excluding parents from the decision-making process and keeping them in the dark (
      • Lenhard-Schramm N.
      Das Land Nordrhein-Westfalen und der Contergan-Skandal: Gesundheitsaufsicht und Strafjustiz in den ‘Langen Sechziger Jahren’.
      ). Experts also objected directly to participatory initiatives. The German Medical Association (BÄK) denigrated the patient-plaintiffs’ fight for resolution as the ‘total’ prosecution (

      H.H., 1970. Der Alsdorfer Prozeß treibt seltsame Blüten: Wie die Nebenklage einen Ablehnungsantrag begründet. Dtsch. Ärztebl. 11, 891–892.

      ); a direct comparison to Nazi Germany’s ‘total war’ effort after 1943. Schering’s legal department aimed to ‘trouble Dr. Moebius wherever it is possible’ (quoted in

      Haarhoff, H., 2016. Der Fall Duogynon: Wer sich nicht einschüchtern ließ. Die Tageszeitung, 28 Jan. 2016. https://taz.de/Der-Fall-Duogynon/!5269859.

      ), and the Federal Association of the Pharmaceutical Industry (BPI) took legal action against him periodically. Ultimately, Moebius was forced to declare bankruptcy and sell his house in Holstein, but not before publishing the Transparency List for German Pharmaceuticals, a 176-page manual available for only 20 DM (
      • Anon
      Teurer Rizinus.
      ).
      The final ruling in the Contergan trial shifted the burden of proof from the patient-plaintiff to the corporate-defendant, and it established (at least in theory) a new epistemic and regulatory regime of postmarket surveillance and risk management: ‘In case of doubt over the teratogenicity of pharmaceuticals, they have to be taken from the market; a final proof of causality […] was not required.’ Legal and medical experts added the following clarification for clinicians: ‘pharmaceutical companies must take preventive measures before the risk of a medication expected to be harmful was scientifically proven’ (
      • Hess
      Haftung der Arzneimittelhersteller bei Verletzung der Leibesfrucht durch Medikamente: Einstellungsbeschluß des Landgerichts Aachen im Strafverfahren gegen Angestellte der Firma Chemie Grünenthal.

      Landgericht Aachen, 1970. Beschluss vom 18 Dec. 1970, 4 KMs 1/68-115/67, Landegericht, Aachen.

      ). However, BÄK clarified immediately that it would not be responsible for verifying any of the information given by pharmaceutical companies regarding drugs and their potential adverse effects (
      • Bundesärztekammer
      Zur Überprüfung der Arzneimittelwerbung im Deutschen Ärzteblatt.
      ). In practice, not much changed.
      In 1973, Schering declared in its internal newsletter that it had ceased marketing Duogynon tablets for pregnancy testing, but without reference to possible risks (
      • Anon
      Produkthistorie Pharma, Inland, Duogynon, Duogynon 166.
      ). Years later, some experts maintained that the change of indication had obviated the need for an official warning (
      • Nocke W.
      Sind Weibliche Sexualsteroide Teratogen? Rückblick, Zwischenbilanz, Konsequenzen.
      ). However, others argued that the new directions had never reached doctors, pharmacists or patients (
      • Hammerstein J.
      Mißbildungen nach Behandlung schwangerer Frauen mit weiblichen Sexualhormonen.
      ). Journalists belatedly charged Schering with intentionally concealing information about Duogynon to shield Anovlar – widely used at that time by approximately 30% of women aged 15–44 (
      • Silies E.
      Liebe, Lust und Last: Die Pille als weibliche Generationserfahrung in der Bundesrepublik, 1960–1980.
      ) – from negative publicity (
      • Anon
      Missbildungen durch Gabe von Sexualsteroiden in der Frühschwangerschaft.
      ,
      • Paul R.
      • Lempke K.
      Nur noch vier Jahre zu leben.
      ). Correspondence in Schering’s archives suggests a corporate strategy for managing uncertain knowledge and maintaining ignorance; namely, to ‘follow only the pressure of the health administrative bodies’ and to ignore ‘any scientific evidence’, even if the data suggested risks in connection to HPTs (quoted in

      Haarhoff, H., 2016. Der Fall Duogynon: Wer sich nicht einschüchtern ließ. Die Tageszeitung, 28 Jan. 2016. https://taz.de/Der-Fall-Duogynon/!5269859.

      ). Regulators, however, seemed satisfied with Schering’s pro-forma information reports and did not apply much pressure.

      Regulating HPTs

      Only in 1978, after Der Spiegel publicized Gal’s and Moebius’s warnings, did a group of German medical experts formally comment on Duogynon. After discussing the application of steroid hormones in early pregnancy at their annual meeting, the German Society for Endocrinology’s Permanent Commission for Steroid Toxicology (SKSDGE) gave an opinion: ‘potential teratogen effects’ of female sex hormones could not be proven, but ‘because of simple laboratory methods available for pregnancy diagnosis there was no need for the antenatal application of estrogens and progestogens for this purpose’ (

      SKSDGE, 1978. Statement, 22 Feb. 1978, S1 Pharma Präparate, Duogynon 166, Schering Archives, Berlin.

      ). SKSDGE communicated the statement to all German gynaecologists and general practitioners (GPs) as ‘important information’ regarding Duogynon as well as Schering’s Gravibinon, Proluton and Proluton Depot, all used to prevent miscarriage.
      Despite its timidity, the statement drew regulatory bodies into the debate. Several weeks later, the Medical Association’s Drug Commission (AkdÄ) released the first official warning against the prescription of hormones in pregnancy; namely, that ‘malformations after treatment of pregnant women with female sex hormones’ led to the clear guideline: ‘No pregnancy test with oral estrogen-progestogen combinations!’ (
      • AkdÄ
      Kein Schwangerschaftstest mit oralen Östrogen-Gestagen-Kombinationen.
      ,
      • Hammerstein J.
      Mißbildungen nach Behandlung schwangerer Frauen mit weiblichen Sexualhormonen.
      ). By then, an international consensus had formed against the antenatal use of synthetic sex hormones (including DES), and several countries – Sweden (1972), Norway (1973), Australia, New Zealand, the USA (1975) and the Netherlands (1977) – had banned the use of HPTs. Belgium, Finland and Britain would follow suit in 1978 (
      • Claes T.
      L’autre scandale ‘Softenon’, tombé dans l’oubli.
      ,
      • Olszynko-Gryn J.
      • Bjørvik E.
      • Weßel M.
      • Jülich S.
      • Jean C.
      A historical argument for regulatory failure in the case of Primodos and other hormone pregnancy tests.
      ,
      • Weßel M.
      Primodos – Hormonaalinen raskaustestaus Suomessa.
      ). However, in the FRG, powerful interests worked against the practical application of the new interdiction.
      Retrospective epidemiological data was, and still is, viewed by many as weak compared with the gold standard of randomized clinical trials (
      • Berlivet L.
      ‘Association or causation?’ The debate on the scientific status of risk factor epidemiology, 1947–c.1965.
      ,
      • Timmermans S.
      • Berg M.
      The Gold Standard: The Challenge of Evidence-Based Medicine and Standardization in Health Care.
      ). Unconvinced that correlations implied causation, some clinical gynaecologists expressed concern that AkdÄ’s warning against HPTs would spread unwarranted ‘worry’ and ‘confusion’ (
      • Nocke W.
      Sind Weibliche Sexualsteroide Teratogen? Rückblick, Zwischenbilanz, Konsequenzen.
      ). Referring to the prospective DFG study and to a smaller Göttingen study, they recommended ‘caution’ but emphasized that a ‘teratogen effect […] was unproven on the basis of a careful analysis of the available data’ (

      DGGG, 1978. Press Release. DGGG, 42. Jahrestagung, 15 Sept. 1978. S1 Pharma Präparate, Duogynon 166, Schering Archives, Berlin.

      ,
      • Knörr K.
      • Berger J.
      • Degenhart K.H.
      • Haller J.
      • Koller S.
      • Kbler W.
      • Mau G.
      Mögliche Einflußfaktoren auf die Entwicklung des Kindes.
      ).
      To distance itself from both its Nazi past and its socialist rival, the German Democratic Republic (GDR), the FRG minimized state involvement in health care and limited access to potentially sensitive statistical data, including data on disability (
      • Lindner U.
      Sicherheits- und Präventionskonzepte im Umbruch: Von der Gruppenvorsorge zur Individualisierten Medizinischen Risikoprävention für Schwangere.
      ,
      • Madarász-Lebenhagen J.
      Perceptions of Health after World War II: Heart Diseases and Risk Factors in East and West Germany, 1945–75.
      ). Many Western countries intensified the surveillance of birth defects after thalidomide (
      • Al-Gailani S.
      Making birth defects ‘preventable’: pre-conceptional vitamin supplements and the politics of risk reduction.
      ,
      • Fairchild A.
      • Bayer R.
      • Colgrove J.
      Searching Eyes: Privacy, the State, and Disease Surveillance in America.
      ,
      • Lee F.
      Detecting the unknown in a sea of knowns: health surveillance, knowledge infrastructures, and the quest for classification egress.
      ). In contrast, the FRG, traumatized by Nazi ‘euthanasia’ and amidst a process of reappraisal, firmly rejected malformation registries; another form of ignorance production. Experts lamented that without a monitoring system, they would be unable to detect teratogenic effects, even if a drug increased the risk for congenital malformation by a factor of 500 (
      • Anon
      Missbildungen durch Gabe von Sexualsteroiden in der Frühschwangerschaft.
      ,
      • Neubert D.
      Medikamentöse Noxen als Indikation zum Schwangerschaftsabbruch.
      ). When the Health Ministry (BMJFG) requested more information about SKSDGE’s opinion, the Federal Public Health Service (BGA) stated – on the grounds that retrospective evidence was inadequate – that HPTs had ‘not been observed’ to cause birth defects in West Germany (BMJFG statement, 7.08.1978, quoted in
      • Lenhard-Schramm N.
      Der Fall Duogynon: Ein Zweiter Contergan-Skandal?.
      ). BMJFG took no further steps (
      • Lenhard-Schramm N.
      Der Fall Duogynon: Ein Zweiter Contergan-Skandal?.
      ).
      New legislation, the Drug Law of 24 August 1976, came into effect in 1978, and created BGA’s Institute for Drugs to oversee drug testing as part of revised licensing procedures. In a climate of intensifying activism around consumer rights, environmental pollution and occupational health (
      • Westermann A.
      When consumer citizens spoke up: West Germany’s early dealings with plastic waste.
      ), the Consumer Associations’ Committee (AGVV), a national umbrella organization to support consumer-citizenship rights, requested a total ban on HPTs (
      • Anon
      Arzneimittel – Ein Gefährlicher Test.
      ). However, after an expert roundtable and discussions in parliament (Deutscher
      • Bundestag Deutscher
      Plenarprotokoll 08/111.
      ), (Deutscher
      • Bundestag Deutscher
      Plenarprotokoll 08/111.
      ) BGA only ‘discouraged’ the use of norethisterone acetate and ethinyl estradiol in pregnancy diagnosis (

      Bundesgesundheitsamt, 1978. Hormone in der Frühschwangerschaft. Expertengespräch im BGA. Bga Presseschau, 12 Oct. 1978.

      ).
      Schering was obliged to communicate the new guidance, but, as BGA’s successor, BfArM (Federal Institute for Drugs and Medical Devices), would later admit, there was ‘no evidence [in BGA’s archives] to say whether or not this happened’ (

      Haarhoff, H., 2010. Der Fluch der Smarties. Die Tageszeitung, 30 Nov. 2010. https://taz.de/!5131352/.

      ). Although BGA does not seem to have actively enforced its guidance, Schering’s records show that information was included in newsletters and with patient information leaflets. The company also removed the diagnostic indication for ampoules and changed the name of the tablets from Duogynon to Cumorit ‘to raise awareness for the new use’ (exclusively as a treatment for amenorrhoea) (

      Schering, 1978. Neues von Schering 27 (Sept. 1978), p. 1. Pharma Präparate, Duogynon 166, Schering Archive Berlin.

      ). Some journalists, however, viewed the rebranding as a cynical manoeuvre to protect a ‘contested drug’ from ‘slander’, and launched further investigations (
      • Paul R.
      • Lempke K.
      Nur noch vier Jahre zu leben.
      ). Despite increasing pressure, Schering’s head of clinical research held fast: HPTs would remain on the West German market to protect the reputation of compositionally similar products, including Anovlar (

      Lachnit-Fixon, U., Letter to W. Nocke from 1 Sept. 1978. Unpublished manuscript, B Rep. 058, 13190, Landesarchiv, Berlin.

      ).

      Off label

      Duogynon/Cumorit, as we have seen, was not one thing. It contained multiple meanings and uses that flexibly accommodated changing regulatory regimes and legislation. In this sense, it was no different from other drugs over which physicians have historically exercised significant authority independent of regulatory oversight (
      • Greene J.A.
      • Watkins E.S.
      Introduction: the prescription in practice.
      ,
      • Marks H.M.
      Making Risks Visible: The Science and Politics of Adverse Drug Reactions.
      ). The US Food and Drug Administration (FDA), for example, regulated the pharmaceutical industry, but tended to leave physicians alone in deference to their professional autonomy (
      • Carpenter D.
      Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA.
      ). Similarly, physicians in the FRG enjoyed considerable ‘therapeutic freedom’ (to prescribe medicines as they saw fit) and were not closely monitored by the state (
      • Kessel N.
      Umstrittene Expertise. Der Beirat ‘Arzneimittelsicherheit’ in der bundesdeutschen Arzneimittelregulierung 1968–1976.
      ).
      As a result, many drugs have led ‘double lives’ (
      • Anon
      Estrogens’ double life.
      ); approved for one thing, but prescribed for something else entirely. Companies are sometimes accused of unethical marketing, as in the Mediator (benfluorex) scandal that rocked France in 2010 (
      • Lellinger S.
      Médicaments et effets secondaires: le Mediator et les dérivés de l’amphétamine.
      ,
      • Lellinger S.
      Innovation thérapeutique et accident médicamenteux: socio-genèse du scandale du ben uorex (Mediator®) et conditions de reconnaissance d’une pathologie émergente: les valvulopathies médicamenteuses.
      ). However, in certain areas of medicine, including paediatrics, psychiatry, oncology and reproduction, ‘off-label’ prescribing is par for the course (
      • Balan S.
      • Hassali M.A.A.
      • Mak V.S.L.
      Two decades of off-label prescribing in children: a literature review.
      ,

      Becker, U., Wilman, N. 2012. Zweifel auf Privatrezept? Sozial- und haftungsrechtliche Aspekte des Off-Label-Use. Nomos, Baden-Baden

      ,
      • Bell J.S.
      • Richards G.C.
      Off-label medicine use: ethics, practice and future directions.
      ,
      • Gershon A.
      • Shorter E.
      How amytal changed psychopharmacy: off-label uses of sodium amytal (1920–40).
      ,
      • Saiyed M.M.
      • Ong P.S.
      • Chew L.
      Off-label drug use in oncology: a systematic review of literature.
      ). Particular classes of drugs, including hormones, have found large markets for unapproved indications (
      • Hoberman J.
      Testosterone Dreams: Rejuvenation, Aphrodisia.
      ,
      • Sanabria E.
      Plastic Bodies: Sex Hormones and Menstrual Suppression in Brazil.
      ). As children and women of childbearing age are excluded from clinical trials, they tend to be more exposed to untested treatments (
      • Epstein S.
      Inclusion: The Politics of Difference in Medical Research.
      ). The situation is further complicated in reproductive medicine by legal grey areas or proscriptions regarding contraception and abortion that discourage manufacturers from applying for licences (
      • Weeks A.D.
      • Fiala C.
      • Safar P.
      Misoprostol and the debate over off-label drug use.
      ).
      Misoprostol, for instance, is indicated for ulcers, but is widely used informally both as an abortifacient (
      • Löwy I.
      • Dias Villela Corrêa M.C.
      The ‘abortion pill’ misoprostol in Brazil: women’s empowerment in a conservative and repressive political environment.
      ,
      • MacDonald M.E.
      Misoprostol: the social life of a life-saving drug in global maternal health.
      ) and to induce labour (
      • Towghi F.
      Normalizing off-label experiments and the pharmaceuticalization of homebirths in Pakistan.
      • Voigt F.
      • Goecke T.W.
      • Najjari L.
      • Pecks U.
      • Maass U.
      • Rath W.
      Off-label use of misoprostol for labor induction in Germany: a national survey.
      ). Soon after the FDA approved DES as a menopause drug, in 1941, physicians started prescribing it, off label, as an informal treatment for miscarriage (
      • Bell S.
      DES Daughters: Embodied Knowledge, and the Transformation of Women’s Health Politics in the Late Twentieth Century.
      ). Later, in the 1960s, it was further repurposed as an (unofficial but not illegal) postcoital contraceptive or ‘morning after pill’ (
      ,
      • Prescott H.M.
      The Morning After: A History of Emergency Contraception in the United States.
      ). When the FDA approved Enovid as a menstrual regulator in 1957, it did so with the understanding that physicians would be prescribing it for contraception (
      • Junod S.W.
      • Marks L.
      Women’s trials: the approval of the first oral contraceptive pill in the United States and Great Britain.
      ,
      • Tone A.
      Devices and Desires: A History of Contraceptives in America.
      ). We are still researching the marketing and prescribing practices around Duogynon, and a complex picture is beginning to emerge.
      Historical evidence is scarce. However, the contraceptive or abortive use of HPTs has been reported anecdotally for the USA, Britain, Israel, Nigeria, Peru and South Korea (
      • Anon
      Estrogens’ double life.
      ,
      • Bonnema J.
      • Dalebout J.A.
      The abuse of high dose estrogen/progestin combination drugs in delay of menstruation: the assumptions and practices of doctors, midwives and pharmacists in a Peruvian city.
      ,
      • Cumberlege J.
      First Do No Harm: The Report of the Independent Medicines and Medical Devices Safety Review.
      ,
      • Harlap S.
      • Prywes R.
      • Davies A.M.
      Birth defects and œstrogens and progesterones in pregnancy.
      ,
      • Ujah I.A.O.
      Sexual activity and attitudes toward contraception among women seeking termination of pregnancy in Zaria, Northern Nigeria.
      ). In Britain, some experts privately suspected women of intentionally misleading their GPs (about the timing of their last period) to gain access to HPTs for the purposes of inducing miscarriage (
      • Smithells R.W.
      Letter to W.H.W.
      ). Isabel Gal herself speculated that HPTs were ‘frequently used to induce abortion’ (
      • Gal I.
      Hormonal imbalance in human reproduction.
      ). This parallel conversation about HPTs tended to happen in private or between experts. In West Germany, however, it was broached publically in Stern, a glossy weekly entertainment and political magazine for young adults that had lobbied for abortion law reform in the early 1970s (

      Anon., 1971. Wir haben abgetrieben! Stern 24, Cover Page.

      ).
      Postcoital contraception was not approved in the FRG until the early 1980s (
      • Olszynko-Gryn J.
      Technologies of contraception and abortion.
      ). Although under development in Sweden from the 1960s (

      Ramsey, M. 2021. The Swedish Abortion Pill: Co-Producing Medical Abortion and Values, ca. 1965–1992. Acta Universitatis Upsaliensis, Uppsala.

      ), abortion pills would not be marketed in any country until 1988, and not in Germany until 1999, well after reunification. As such, in the late 1970s – after abortion law reform but in the absence of officially sanctioned options for postcoital contraception or pharmaceutical abortion – women and their doctors improvised what a pair of journalists writing in Stern magazine evocatively called ‘the Duogynon ritual’.
      In 1978, shortly after Schering had removed the diagnostic indication for Duogynon, they reported that West German doctors had prescribed no fewer than 550,000 doses of the drug in a single year; a conspicuously large number next to the estimated 125,000 women suffering from secondary amenorrhoea each year. On the basis of available sources, it is difficult to confirm the discrepancy, or whether Schering discouraged, ignored or actively supported unapproved uses of its product to maintain sales. What matters here is that the claim was publicly debated and prompted critics to question the reproductive politics of Duogynon and the meaning of its popularity.
      Many GPs, it seems, remained ignorant of the changed indication and potential risk, and so continued to prescribe Duogynon, in good faith, as a pregnancy test. Others reportedly prescribed Duogynon to ‘stall’ patients seeking an abortion; if the drug did not induce miscarriage, then the operation would be delayed, at greater risk to the patient (
      • Wolff U.
      Ist die “Reform des §218” gescheitert?.
      ). Still others, Stern alleged, conspired with their patients to use Duogynon as a postcoital contraceptive or abortifacient (
      • Paul R.
      • Lempke K.
      Nur noch vier Jahre zu leben.
      ). As with many other once-popular practices of birth control (
      • Fisher K.
      Birth Control, Sex, and Marriage in Britain, 1918–1960.
      ,
      • Jones C.L.
      The Business of Birth Control: Contraception and Commerce in Britain Before the Sexual Revolution.
      ), we may never know how effective Duogynon was at achieving the desired result. In Britain, however, experts privately agreed that HPTs ‘undoubtedly’ induced miscarriage (
      • Hobson B.M.
      Letter to J.
      ), especially in ‘not well established’ pregnancies (
      • Warrack A.J.N.
      Letter to J.
      ); they estimated that approximately 10% of ‘negative’ results were really abortions (

      Dean, N., 1968. Hormone pregnancy tests (17 May). MH 71/39. National Archives, London.

      ).
      West German women who knowingly used Duogynon as a morning after pill or abortifacient tended to be well educated and middle class. For them, tactical ignorance about whether or not conception had occurred functioned as a resource. In this sense, the Duogynon ritual resembled the venerable practice of taking ‘female pills’ to induce ambiguous uterine bleeding and other practices of menstrual regulation (
      • Murphy M.
      Seizing the Means of Reproduction: Entanglements of Feminism, Health, and Technoscience.
      ,
      • Olszynko-Gryn J.
      Technologies of contraception and abortion.
      ,
      • Pavard B.
      The right to know? The politics of information about contraception in France (1950s–80s).
      ,
      • van de Walle E.
      • Renne E.P.
      Regulating Menstruation: Beliefs, Practices.
      ). Many other women, however, had taken Duogynon at face value as a pregnancy test or treatment for amenorrhoea. A subset of these women had been pregnant at the time and, following the birth of a child with a heart defect or shortened limb, subsequently learned about the possible teratogenic risk in a newspaper or magazine. It was these mothers who publicly accused Schering, ‘irresponsibly and knowing doctors’ ignorance and prescribing habits, of contributing daily to the use of women as test objects and the burdening of their pregnancies with unimaginable fears’ (

      IGDGK, 1979. Gefahr Duogynon/Cumorit, https://duogynonopfer.de/wp-content/uploads/FlyerIGDGK1979.pdf.

      ).

      The challenge from parent-activists

      As with their counterparts in other countries (
      • Kline W.
      Bodies of Knowledge: Sexuality, Reproduction, and Women’s Health in the Second Wave.
      ,
      • Murphy M.
      Seizing the Means of Reproduction: Entanglements of Feminism, Health, and Technoscience.
      ,
      • Olszynko-Gryn J.
      The feminist appropriation of pregnancy testing in 1970s Britain.
      ,
      • Pavard B.
      The right to know? The politics of information about contraception in France (1950s–80s).
      ), women’s health campaigners in West Germany challenged medical paternalism and promoted an alternative epistemology that stemmed from embodied knowledge (
      • Tuana N.
      The Speculum of Ignorance: The Women’s Health Movement and Epistemologies of Ignorance.
      ). Following the example of the Boston Women’s Health Book Collective (
      • Davis K.
      The Making of Our Bodies, Ourselves: How Feminism Travels Across Borders.
      ), a group of women who had met in 1971 at a landmark abortion law reform demonstration in Berlin self-published Frauenhandbuch Nr. 1. The chapter on the pharmaceutical industry critiqued Schering’s monopoly on ‘ovulation inhibitors’, and indicted Duogynon not for causing birth defects, but for generating unconscionably high-profit margins due to state ignorance for regulation and safety: ‘Our abdomen: their best business’ (

      Brot und Rosen, 1972. Frauenhandbuch Nr. 1: Abtreibung und Verhütungsmittel. Brot und Rosen, Berlin

      ). Feminist activism helped to bring about abortion law reform in 1976 (
      • Ferree M.M.
      Feminismen: Die Deutsche Frauenbewegung in globaler Perspektive.
      ,
      • Herzog D.
      Schwangerschaftsabbruch, Behinderung, Christentum: Die Ambivalenzen der Sexuellen Revolution in Westeuropa in den 1960er und -70er Jahren.
      ). From the mid 1970s, it sustained a larger public debate on women’s reproductive health (
      • Kuhlmann E.
      • Kolip P.
      Gender und Public Health: Grundlegende Orientierungen für Forschung.
      ,

      Nemec, B., 2020. Unerledigte Anliegen, in: Güttler, N., Rhyner, N., Stadler, M. (Eds.), Cache 01: Gegen-Wissen. Intercom, Zürich, pp. IV/104–IV/105.

      ,

      Schulz, K., 2002. Der lange Atem der Provokation: Die Frauenbewegung in der Bundesrepublik und in Frankreich 1968-1976. Campus, Frankfurt a. M.

      ,
      • Silies E.
      Liebe, Lust und Last: Die Pille als weibliche Generationserfahrung in der Bundesrepublik, 1960–1980.
      ). However, direct resistance to Duogynon as a possible teratogen came from elsewhere.
      Around 200 parents formed the Interest Group for Duogynon-Damaged Children (IGDGK) in 1978. The group was initiated by Edeltraud Müller from Offenbach near Frankfurt, whose daughter Ursula was born with spina bifida; unlike in her previous pregnancies, the mother of seven had been prescribed Duogynon to ‘reactivate menstruation’ (
      • Paul R.
      • Lempke K.
      ). The mothers and fathers who joined forces with Müller were not seasoned activists; they did not come together at a demonstration in Berlin, but rather found one another via newspaper appeals. In this sense, they resembled other interest groups that promoted awareness about specific conditions (
      • Epstein S.
      Patient groups and health movements.
      ,
      • Lindner U.
      Gesundheitspolitik in der Nachkriegszeit: Großbritannien und die Bundesrepublik Deutschland im Vergleich.
      ,
      • Söderfeldt Y.
      Krankheit verbindet: Strategien und Strukturen deutscher Patientenvereine im 20.
      ).
      IGDGK demanded a ban on the ‘second Contergan’ and prepared to take legal action against Schering (

      IGDGK, 1979. Gefahr Duogynon/Cumorit, https://duogynonopfer.de/wp-content/uploads/FlyerIGDGK1979.pdf.

      ). Crucially, Stern supported the campaign with a series of in-depth reports that pictured the children – some with limb defects reminiscent of thalidomide, others with life-shortening organ damage – in their homes in West Germany (Neuwied, Pfronten, Waldrach, Wanne-Eickel) and Britain (Liverpool, Manchester), where a similar campaign was underway. Two investigative journalists specialized in sexual and reproductive health, Klaus Lempke and Rainer Paul, gave a voice to mothers who had taken HPTs while pregnant, and to the parents of children who had died young.
      With dramatic headlines (‘A Thousand Children Are Impeaching’; ‘Who Will Help Us?’; ‘Suspicion Hardened’), Stern amplified the charges that campaigners brought against Schering for intentionally withholding information. It pressed the case for regulatory failure and the uneven distribution of public knowledge about the possible risks of HPTs in different parts of the world (
      • Anon
      Ich dachte, ich bringe das Baby um.
      ,
      • Paul R.
      • Lempke K.
      Nur noch vier Jahre zu leben.
      ,
      • Red
      Verdacht erhärtet.
      ). In addition, it reported on a leaked confidential correspondence between Schering’s West German headquarters and its British subsidiary, Pharmethicals (

      Olszynko-Gryn, J., 2017. Drug scandals and the media – the unresolved case of Primodos. Guardian, 22 Mar. 2017.

      ). London medical directors had pleaded that it was Schering’s ‘moral duty’ to take Primodos off the market until the drug was proved ‘safe’. However, management in West Berlin maintained that the results of Schering’s in-house clinical research were “anything but alarming and we don’t see a reason to withdraw ‘Primodos’” (quoted in
      • Paul R.
      • Lempke K.
      Nur noch vier Jahre zu leben.
      ). Concerned with the report, Schering hired Cologne attorneys to prohibit sales of the offending issue of Stern in Britain (

      Haarhoff, H., 2016. Der Fall Duogynon: Wer sich nicht einschüchtern ließ. Die Tageszeitung, 28 Jan. 2016. https://taz.de/Der-Fall-Duogynon/!5269859.

      ). However, the warnings had already reached a large, international readership (
      • Anon
      Informationen.
      ,
      • Kamke J.
      Schwangerschaftstest mit Folgen. Ist Duogynon verantwortlich für Mißbildungen an Tausenden von Kindern?.
      ,
      • Kamke J.
      Arzneimittel in der Dritten Welt: Pillen ohne Gewähr.
      ). In the following months, the charges shifted to court.
      Armed with animal evidence of teratogenicity dating back to 1969 (

      Setsevits, S., 1981. In dem Ermittlungsverfahren gegen Dr. Hannse u.a. Unpublished manuscript, B Rep. 058 – Staatsanwaltschaft, 1832. Landesarchiv Berlin.

      ), IGDGK initiated legal action against Schering in August 1978 (

      Dudda, S., 1982. Verfahren Beendet, Jul 1982, Duogynon XL 1.38/01, Schering Archives, Berlin.

      ). The defence counsel responded by enlisting scientists, including Koller, as expert witnesses. From a statement by the team, we know that, in a preparatory meeting in October 1978, Koller proposed dismissing patient testimonials regarding adverse effects (

      Setsevits, S., 1981. In dem Ermittlungsverfahren gegen Dr. Hannse u.a. Unpublished manuscript, B Rep. 058 – Staatsanwaltschaft, 1832. Landesarchiv Berlin.

      ). This is consistent with his previous support for discriminatory practices against vulnerable groups as the leading biostatistician under National Socialism (
      • Schappacher N.
      • Oehler-Klein S.
      Siegfried Koller und die neuen Herausforderungen der Statistik im Nationalsozialismus.
      ). Koller was generally hostile towards parent-campaigners and enjoyed ‘amicable relations’ with Schering and the BGA (

      Setsevits, S., 1981. In dem Ermittlungsverfahren gegen Dr. Hannse u.a. Unpublished manuscript, B Rep. 058 – Staatsanwaltschaft, 1832. Landesarchiv Berlin.

      ). As an influential, well-networked expert, he was able to exploit established hierarchies to perpetuate the uneven distribution of biomedical knowledge and ignorance about iatrogenic birth defects in the FRG; a young nation where children in general, and people with disabilities (including children), were still only weakly enfranchised (

      Rudloff, W., 2002. Im Schatten des Wirtschaftswunders: Soziale Probleme, Randgruppen und Subkulturen 1949 bis 1973, in: Schlemmer, T., Woller, H. (Eds.), Gesellschaft im Wandel: 1949 bis 1973. Oldenbourg, München, pp. 347–467.

      ).
      The public prosecutor’s preliminary investigation ended after 2 years, on 19 December 1980, with a pre-trial decision that no negligent physical injury or offence against the drug law could have occurred because the unborn were not protected by the constitution of the FRG (

      Netzwerk Duogynon, 2019. Die Geschichte, https://duogynonopfer.de/geschichte/.

      ). Significantly, the decision came at a time of renewed antiabortion and disability rights activism (
      • Herzog D.
      Unlearning Eugenics: Sexuality, Reproduction, and Disability in Post-Nazi Europe.
      ); we are still in the process of exploring the connections, but it may have come as a relief to defenders of the 1976 abortion law. Schering, meanwhile, removed Duogynon from the West German market in February 1981, later than in other Western countries. Rebranded as Cumorit, it remained available in India and other ‘developing’ nations well into the 1980s (
      • Marcelis C.
      • Shiva M.
      EP drugs: unsafe by any name.
      ,
      • Silverman M.
      • Lydecker M.
      • Lee P.R.
      Bad Medicine: The Prescription Drug Industry and the Third World.
      ). Today, Congolese women still use unauthorized pills labelled ‘Duogynon’ for postcoital contraception (
      • Hernandez J.H.
      • Akilimalib P.
      • Mbadu M.F.
      Provision of emergency contraceptive pills in Kinshasa’s informal drug shops: results from a mystery client study.
      ); a telling hangover from the past. Norethisterone acetate and ethinyl estradiol continue to be found in contraceptives, treatments for endometriosis, and period delayers. However, the diagnostic use of sex hormones in early pregnancy is not coming back.

      Producing ignorance (about iatrogenic birth defects)

      This article has examined the West German controversy over Duogynon, the original HPT and drug at the centre of the first major, international debate over iatrogenic birth defects of the post-thalidomide era. Sparked by Isabel Gal in 1967, the debate came to focus on the synthetic sex hormones, including DES. An international consensus formed in the 1970s that HPTs were unnecessary, correlated with birth defects, and should not be used in pregnancy. Crucially and in contrast to thalidomide and DES, however, the question of causation remained (or was actively kept) open in the case of Duogynon. The history of HPTs has much to teach about how teratology after thalidomide produced not only new knowledge, but also doubt, uncertainty and structured forms of ignorance (about iatrogenic birth defects). It also provides grounds for revisiting and reflecting on historical relationships between reproductive politics, civil society and disability in post-thalidomide West Germany.
      In West Germany, the global epicentre of the thalidomide disaster, a powerful coalition of pharmaceutical industrialists, politicians and biomedical researchers exerted control over the production, circulation and reception of biomedical knowledge about birth defects. The perpetuation of ignorance about a possibly causal association between Duogynon and birth defects also benefited from nationally specific historical continuities regarding: established pathways in the organization of biomedical research; the high standing and political support enjoyed by the pharmaceutical industry as emblematic of national regeneration and economic growth; and National Socialism’s legacy of highly authoritarian power structures. An aversion to collectivist approaches in public health care (associated with the Third Reich and the GDR) further militated against the surveillance of birth defects in the FRG.
      The DFG study, directed by Koller, was lauded in Britain as the ‘most comprehensive investigation ever conducted’ into iatrogenic birth defects (
      • Olszynko-Gryn J.
      • Bjørvik E.
      • Weßel M.
      • Jülich S.
      • Jean C.
      A historical argument for regulatory failure in the case of Primodos and other hormone pregnancy tests.
      ). However, on closer inspection, surprising omissions come into view. As we have shown, the study was an exercise not only in the production of knowledge, but also in the perpetuation of ignorance. As if designed to generate a null result, it failed to collect crucial information, excluded the majority of patients from analysis, discarded data, and systematically interpreted significant correlations as non-causal – methodological issues that became apparent not only in retrospect, but were remarked on at the time.
      It fell to parent-activists to challenge the negative findings as well as the status quo they upheld. Less powerful actors – the mothers and fathers of ‘Duogynon-damaged children’ – proved sufficiently resourceful to mobilize allies. Aided by whistleblowers, journalists and lawyers, they succeeded in shifting the arena of debate to the public sphere. Having forged new alliances, parent-activists redrew the borders of knowledge and ignorance (about iatrogenic birth defects). By bringing to light apparently supressed information, they seemed to expose something resembling a cover up (
      • Stücken C.
      Der Vertuschte Skandal: Ein Pharmakonzern und sein Hormonpräparat.
      ). Their legal action failed, but it generated a massive archive that may yet prove consequential. As an example of the active production of ignorance, the Duogynon controversy is typical of asymmetrical power struggles over the uneven distribution of biomedical knowledge – and structured absences of knowledge – that continue to this day. Not just another drug scandal, it was pivotal in a larger and more international debate that centred first on thalidomide, then on synthetic sex hormones (including HPTs and DES), and subsequently on a succession of other drugs.

      Declaration

      The author reports no financial or commercial conflicts of interest.

      Acknowledgements

      The authors wish to thank the anonymous reviewers, section editor, editors of this special issue, members of the Virtual Reproduction Circle, members of the working group Family, Parenthood and Reproduction (Heidelberg University), and colleagues for comments on drafts; and Daniel Anderson, Rachel Arkell, Thore Grimm, Nils Kessel, Beate Kirk, Perside Ndandu and Ylva Söderfeldt for help on specific points. This research was supported by the Arts and Humanities Research Council and the German Research Foundation, through a UK-German Funding Initiative in the Humanities Grant (AH/T013281/1; 429045347); the German Federal Ministry of Education and Research; and the German Aerospace Centre (01UL1907X).

      German Abbreviations

      AGVV, Arbeitsgemeinschaft der Verbraucherverbände e.V. (Consumer Associations’ Committee)
      AkdÄ, Arzneimittelkommission der deutschen Ärzteschaft (Drugs Commission of the German Medical Association)
      BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices)
      BPI, Bundesverband der Pharmazeutischen Industrie (Federal Association of the Pharmaceutical Industry)
      BGA, Bundesgesundheitsamt (Federal Health Agency)
      BMJFG, Bundesministerium für Jugend, Familie und Gesundheit (Federal Ministry for Youth, Family and Health)
      DFG, Deutsche Forschungsgemeinschaft (German Research Foundation)
      DGGG, Deutsche Gesellschaft für Gynäkologie und Geburtshilfe (German Society of Obstetrics and Gynaecology)
      BÄK, Bundesärztekammer (German Medical Association)
      IGDGK, Interessensgemeinschaft Duogynongeschädigter Kinder, e.V. (Interest Group for Duogynon-Damaged Children)
      SKSDGE, Ständige Kommission für Steroidtoxikologie der Deutschen Gesellschaft für Endokrinologie (Permanent Commission for Steroid Toxicology of the German Society for Endocrinology).

      References

        • AkdÄ
        Kein Schwangerschaftstest mit oralen Östrogen-Gestagen-Kombinationen.
        Dtsch. Ärztebl. 1978; 75: 1751
        • Al-Gailani S.
        Making birth defects ‘preventable’: pre-conceptional vitamin supplements and the politics of risk reduction.
        Stud. Hist. Phil. Biol. Biomed. Sci. 2014; 47: 278-289https://doi.org/10.1016/j.shpsc.2013.10.009
        • Aly G.
        • Roth K.H.
        The Nazi Census: Identification and Control in the Third Reich.
        Temple University Press, Philadelphia, PA2004
        • Anon
        Estrogens’ double life.
        Sci. News. 1967; 92: 343
      1. Anon., 1971. Wir haben abgetrieben! Stern 24, Cover Page.

        • Anon
        Produkthistorie Pharma, Inland, Duogynon, Duogynon 166.
        Schering Archives, Berlin1973
      2. Anon., 1975. Nach Pille und Sexueller Befreiung. Die neuen Krankheiten. Der Spiegel 17, Cover Page.

        • Anon
        Teurer Rizinus.
        Der Spiegel. 1977; 4: 126-127
      3. Anon., 1977b. Überdruß an der Pille. Der Spiegel 6, Cover Page.

        • Anon
        Gefährlicher Test.
        Der Spiegel. 1977; 43: 271
        • Anon
        Informationen.
        Brigitte. 1978; 7: 174-179
        • Anon
        Missbildungen durch Gabe von Sexualsteroiden in der Frühschwangerschaft.
        Arznei-Telegramm. 1978; 9: 83-86
        • Anon
        Arzneimittel – Ein Gefährlicher Test.
        Rückspiegel. Der Spiegel. 1978; 33: 154
        • Anon
        Ich dachte, ich bringe das Baby um.
        Stern. 1978; 36: 31
      4. Aranova E. von Oertzen C. Sepkoski D. Data Histories (Osiris, 32). University of Chicago Press, Chicago, IL2017
        • Balan S.
        • Hassali M.A.A.
        • Mak V.S.L.
        Two decades of off-label prescribing in children: a literature review.
        World J. Pediatr. 2018; 14: 528-540
      5. Becker, U., Wilman, N. 2012. Zweifel auf Privatrezept? Sozial- und haftungsrechtliche Aspekte des Off-Label-Use. Nomos, Baden-Baden

        • Bell J.S.
        • Richards G.C.
        Off-label medicine use: ethics, practice and future directions.
        Aust. J. Gen. Pract. 2021; 50: 329-331
        • Bell S.
        DES Daughters: Embodied Knowledge, and the Transformation of Women’s Health Politics in the Late Twentieth Century.
        Temple University Press, Philadelphia, PA2009
        • Berlivet L.
        ‘Association or causation?’ The debate on the scientific status of risk factor epidemiology, 1947–c.1965.
        in: Berridge V. Making Health Policy: Networks in Research and Policy after 1945 (Clio Medica, 75). Rodopi, Amsterdam2005: 39-74
        • Bonnema J.
        • Dalebout J.A.
        The abuse of high dose estrogen/progestin combination drugs in delay of menstruation: the assumptions and practices of doctors, midwives and pharmacists in a Peruvian city.
        Soc. Sci. Med. 1992; 34: 281-289
        • Bösl E.
        The Contergan Scandal: Media, Medicine, and Thalidomide in 1960s West Germany.
        in: Burch S.W. Rembis M. Disability Histories (Disability Histories). University of Illinois Press, Urbana/ Chicago/ Springfield2014: 136-162
        • Broman S.H.
        The Collaborative Perinatal Project: an overview.
        in: Handbook of Longitudinal Research. Vol. 1. Praeger, New York1984: 185-227
      6. Brot und Rosen, 1972. Frauenhandbuch Nr. 1: Abtreibung und Verhütungsmittel. Brot und Rosen, Berlin

        • Brown S.
        • Fraga L.R.
        • Cameron G.
        • Erskine L.
        • Vargesson N.
        The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebra fish embryos.
        Sci. Rep. 2018; 8: 2917https://doi.org/10.1038/s41598-018-21318-9
        • Bundesärztekammer
        Zur Überprüfung der Arzneimittelwerbung im Deutschen Ärzteblatt.
        Dtsch. Ärztebl. 1972; 16: 1010
      7. Bundesgesundheitsamt, 1978. Hormone in der Frühschwangerschaft. Expertengespräch im BGA. Bga Presseschau, 12 Oct. 1978.

        • Carpenter D.
        Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA.
        Princeton University Press, Princeton, NJ2010
        • Claes T.
        L’autre scandale ‘Softenon’, tombé dans l’oubli.
        Le Vif. 2020; 42: 36-41
        • Cody P.
        DES Voices: From Anger to Action.
        DES Action, Columbus, OH2008
        • Cumberlege J.
        First Do No Harm: The Report of the Independent Medicines and Medical Devices Safety Review.
        Crown Copyright, London2020
        • Daemmrich A.
        A tale of two experts: thalidomide and political engagement in the United States and West Germany.
        Soc. Hist. Med. 2002; 15: 137-158
        • Daemmrich A.
        Pharmacopolitics: Drug Regulation in the United States and West Germany.
        University of North Carolina Press, Chapel Hill, NC2004
        • Davis K.
        The Making of Our Bodies, Ourselves: How Feminism Travels Across Borders.
        Duke University Press, Durham, NC2007
      8. Dean, N., 1968. Hormone pregnancy tests (17 May). MH 71/39. National Archives, London.

        • Degenhardt K.H.
        Schwangerschaftsverlauf und Kindesentwicklung: Ein überregionales Prospektives Forschungsprojekt.
        Dtsch. Ärztebl. 1972; 19: 1921-1925
        • Bundestag Deutscher
        Plenarprotokoll 08/111.
        Bundesregierung, Berlin1978
        • Bundestag Deutscher
        Verhandlungen des Deutschen Bundestags: Stand der Aufklärung zur Rolle deutscher Behörden hinsichtlich der Registrierung und Pharmakovigilanz von Duogynon. Drucksache 19/28270.
        Bundesregierung, Berlin2021
        • DFG
        Bericht der DFG über das Projekt Schwangerschaftsverlauf und Kindesentwicklung.
        Deutsche Forschungsgemeinschaft, Bonn1963
        • DFG
        Schwangerschaftsverlauf und Kindesentwicklung: DFG Forschungsbericht.
        Harald Boldt, Boppard1977
      9. DGGG, 1978. Press Release. DGGG, 42. Jahrestagung, 15 Sept. 1978. S1 Pharma Präparate, Duogynon 166, Schering Archives, Berlin.

        • Döring G.
        Empfängnisverhütung: Ein Leitfaden für Ärzte und Studenten.
        Thieme, Stuttgart1971
        • Dron H.A.
        Teratology Transformed: Uncertainty, Knowledge, and Conflict over Environmental Etiologies of Birth Defects in Midcentury America.
        (PhD thesis) University of California, San Francisco2016
        • Dubowitz V.
        Virilisation and malformation of a female infant.
        Lancet. 1962; 280 (25 Aug.): 405-406
      10. Dudda, S., 1982. Verfahren Beendet, Jul 1982, Duogynon XL 1.38/01, Schering Archives, Berlin.

        • Epstein S.
        Inclusion: The Politics of Difference in Medical Research.
        University of Chicago Press, Chicago2007
        • Epstein S.
        Patient groups and health movements.
        in: Hackett E. Amsterdamska O. Lynth M. Wajcman J. The Handbook of Science and Technology Studies. MIT Press, Cambridge (MAS)2008: 499-539
        • Fairchild A.
        • Bayer R.
        • Colgrove J.
        Searching Eyes: Privacy, the State, and Disease Surveillance in America.
        University of California Press, Berkeley, CA2007
        • Farrell J.
        • Lane L.
        Primodos: The Secret Drug Scandal.
        Sky News, 2017
        • Farrell J.
        • Lane L.
        Bitter Pill: Primodos.
        Sky News, 2020
      11. Ferguson, I., 2021. A Face to Die for: Acne, Dermatology, and the Quest for Perfect Skin in Britain and the United States, c.1800–present. PhD thesis. University of Strathclyde, Glasgow.

        • Ferree M.M.
        Feminismen: Die Deutsche Frauenbewegung in globaler Perspektive.
        Campus, Frankfurt2018
        • Fillion E.
        • Torny D.
        Un précédent manqué: le Distilbène® et les perturbateurs endocriniens. Contribution à une sociologie de l’ignorance.
        Sci. Soc. Santé. 2016; 34: 47-75
        • Fillion E.
        • Torny D.
        ‘Like mother, like daughter, like grand-daughter...’: Transgenerational ignorance engendered by a defective reproductive health technology.
        Reprod. Biomed. Soc. Online, this issue. 2021;
        • Fisher K.
        Birth Control, Sex, and Marriage in Britain, 1918–1960.
        Oxford University Press, Oxford2006
      12. Foster A.M. Wynn L.L. Emergency Contraception: The Story of a Global Reproductive Health Technology. Palgrave Macmillan, New York2012
        • Frickel S.
        • Gibbon S.
        • Howard J.
        • Kempner J.
        • Ottinger G.
        • Hess D.
        Undone science: charting social movement and civil society challenges to research agenda setting.
        Sci. Technol. Human Values. 2010; 35: 444-473
        • Gal I.
        Hormonal imbalance in human reproduction.
        in: Advances in Teratology. Vol. 5. Academic Press, New York1972: 161-173
        • Gal I.
        • Kirman B.
        • Stern J.
        Hormonal pregnancy tests and congenital malformation.
        Nature. 1967; 216: 83
        • Gaudillère J.P.
        DES, cancer and endocrine perturbation: ways of regulating, chemical risks and public expertise in the United States.
        in: Boudia S. Jas N. Powerless Science? Science and Politics in a Toxic World, Berghahn, New York2014: 65-94
        • Gaudillière J.P.
        Sex hormones, pharmacy and the reproductive sciences.
        in: Hopwood N. Flemming R. Kassell L. Reproduction: Antiquity to the Present Day. Cambridge University Press, Cambridge2018: 521-534
        • Gershon A.
        • Shorter E.
        How amytal changed psychopharmacy: off-label uses of sodium amytal (1920–40).
        Hist. Psychiatry. 2019; 30: 352-358
      13. Grebe, H., 1955. Übertoxische Fruchtschädigungen. Der Landarzt 31, 123–26

        • Green M.D.
        Bendectin and Birth defects: The Challenges of Mass Toxic Substances Litigation.
        University of Pennsylvania Press, Philadelphia, PA1996
        • Greene J.A.
        • Watkins E.S.
        Introduction: the prescription in practice.
        in: Greene J.A. Watkins E.S. Prescribed: Writing, Filling, Using, and Abusing the Prescription in Modern America. Johns Hopkins University Press, Baltimore, MD2012: 1-22
      14. H.H., 1970. Der Alsdorfer Prozeß treibt seltsame Blüten: Wie die Nebenklage einen Ablehnungsantrag begründet. Dtsch. Ärztebl. 11, 891–892.

      15. Haarhoff, H., 2010. Der Fluch der Smarties. Die Tageszeitung, 30 Nov. 2010. https://taz.de/!5131352/.

      16. Haarhoff, H., 2016. Der Fall Duogynon: Wer sich nicht einschüchtern ließ. Die Tageszeitung, 28 Jan. 2016. https://taz.de/Der-Fall-Duogynon/!5269859.

        • Hammerstein J.
        Mißbildungen nach Behandlung schwangerer Frauen mit weiblichen Sexualhormonen.
        Dtsch. Ärztebl. 1978; 30: 1751-1752
        • Hardy J.B.
        The collaborative perinatal project: lessons and legacy.
        Ann. Epidemiol. 2003; 13: 303-311
        • Harlap S.
        • Prywes R.
        • Davies A.M.
        Birth defects and œstrogens and progesterones in pregnancy.
        Lancet. 1975; 305: 682-683
        • Hartl H.
        Welche Medikamente sollen in der Schwangerschaft nicht gegeben werden?.
        Med. Klin. 1961; 56: 1208-1209
        • Henegahn C.
        • Aronson J.
        • Spencer E.
        • Holman B.
        • Mahtani K.
        • Perera R.
        • Onakpoya I.
        Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis.
        F1000Res. 2019; 7: 1725https://doi.org/10.12688/f1000research.16758.2
        • Heneghan C.
        • Aronson J.
        Forgotten Primodos story and the roles of general practitioners.
        BMJ Evid. Based Med. 2021; 26: 79-81https://doi.org/10.1136/bmjebm-2019-111307
        • Heneghan C.
        • Aronson J.K.
        Sodium valproate: who knew what and when? Cumulative meta-analysis gives extra insights.
        BMJ Evid. Based Med. 2019; 24: 127-129
        • Hernandez J.H.
        • Akilimalib P.
        • Mbadu M.F.
        Provision of emergency contraceptive pills in Kinshasa’s informal drug shops: results from a mystery client study.
        Int. Perspect. Sex. Reprod. Health. 2020; 46: 89-97
        • Herzog D.
        Schwangerschaftsabbruch, Behinderung, Christentum: Die Ambivalenzen der Sexuellen Revolution in Westeuropa in den 1960er und -70er Jahren.
        in: Busch U. Hahn D. Abtreibung: Diskurse und Tendenzen: KörperKulturen. Transcript, Bielefeld2014: 121-138
        • Herzog D.
        Unlearning Eugenics: Sexuality, Reproduction, and Disability in Post-Nazi Europe.
        University of Wisconsin Press, Madison, WI2018
        • Hess
        Haftung der Arzneimittelhersteller bei Verletzung der Leibesfrucht durch Medikamente: Einstellungsbeschluß des Landgerichts Aachen im Strafverfahren gegen Angestellte der Firma Chemie Grünenthal.
        Dtsch. Ärztebl. 1972; 16: 1005-1010
        • Hoberman J.
        Testosterone Dreams: Rejuvenation, Aphrodisia.
        University of California Press, Berkeley, Doping2005
        • Hobson B.M.
        Letter to J.
        National Archives, London1966
      17. IGDGK, 1979. Gefahr Duogynon/Cumorit, https://duogynonopfer.de/wp-content/uploads/FlyerIGDGK1979.pdf.

        • Johnson M.
        • Stokes R.
        • Arndt T.
        The Thalidomide Catastrophe: How It Happened, Who Was Responsible and Why the Search for Justice Continues After More Than Six Decades.
        Onwards and Upwards, Exeter2018
        • Jones C.L.
        The Business of Birth Control: Contraception and Commerce in Britain Before the Sexual Revolution.
        Manchester University Press, Manchester2020
        • Junod S.W.
        • Marks L.
        Women’s trials: the approval of the first oral contraceptive pill in the United States and Great Britain.
        J. Hist. Med. Allied Sci. 2002; 57: 117-160
        • Kalter H.
        Teratology in the 20th century: Environmental causes of congenital malformations in humans and how they were established.
        Neurotoxicol. Teratol. 2003; 25: 131-282
        • Kamke J.
        Schwangerschaftstest mit Folgen. Ist Duogynon verantwortlich für Mißbildungen an Tausenden von Kindern?.
        Die Zeit. 1978; 32 (4: 41-43
        • Kamke J.
        Arzneimittel in der Dritten Welt: Pillen ohne Gewähr.
        Die Zeit. 1978; 41 (6: Oct.)
        • Kessel N.
        Umstrittene Expertise. Der Beirat ‘Arzneimittelsicherheit’ in der bundesdeutschen Arzneimittelregulierung 1968–1976.
        Medizinhist. J. 2009; 44: 61-93
        • Kessel N.
        Contergan in der Konsumgesellschaft: Wissen und Nichtwissen über Arzneimittelverbrauch in der Bundesrepublik, 1955–1962.
        in: Großbölting T. Lenhard-Schramm N. Contergan: Hintergründe und Folgen eines Arzneimittel-Skandals. Vandenhoeck & Ruprecht, Göttingen2017: 71-98
      18. Kessel, N., 2019. La perte de confiance des citoyens. Les risques médicamenteux pendant la crise de la thalidomide en Allemagne de l’Ouest, 1962. Anthropol. santé 19, doi: 10.4000/anthropologiesante.5335.

        • Kirk B.
        Der Contergan-Fall. Eine unvermeidbare Arzneimittelkatastrophe?: Zur Geschichte des Arzneistoffs Thalidomid.
        WVG, Stuttgart1999
        • Klebanoff M.A.
        The Collaborative Perinatal Project: A 50-year retrospective.
        Paediatr. Perinat. Epidemiol. 2009; 23: 2-8
        • Kline W.
        Bodies of Knowledge: Sexuality, Reproduction, and Women’s Health in the Second Wave.
        University of Chicago Press, Chicago, IL2010
        • Knörr K.
        • Berger J.
        • Degenhart K.H.
        • Haller J.
        • Koller S.
        • Kbler W.
        • Mau G.
        Mögliche Einflußfaktoren auf die Entwicklung des Kindes.
        Arch. Gynakol. 1975; 219: 261
      19. Koller, S., 1972. Die Kooperativ-Studie ‘Schwangerschaftsverlauf Und Kindesentwicklung’, in: Saling, E., Dudenhausen, J.W. (Eds.), Perinatale Medizin. Georg Thieme, Stuttgart, pp.

        • Koller S.
        The German Collaborative Study on Pregnancy Course and Child-Development.
        Teratology. 1974; 10: 314
        • Koller S.
        Risikofaktoren der Schwangerschaft: Auswertung von 7870 Schwangerschaften der Prospektiven Untersuchungsreihe ‘Schwangerschaftsverlauf Und Kindesentwicklung’ der Deutschen Forschungsgemeinschaft.
        Springer, Berlin, New York1983
        • Kuhlmann E.
        • Kolip P.
        Gender und Public Health: Grundlegende Orientierungen für Forschung.
        Praxis und Politik. Grundlagentexte Gesundheitswissenschaften, Juventa, Weinheim2005
      20. Lachnit-Fixon, U., Letter to W. Nocke from 1 Sept. 1978. Unpublished manuscript, B Rep. 058, 13190, Landesarchiv, Berlin.

      21. Landgericht Aachen, 1970. Beschluss vom 18 Dec. 1970, 4 KMs 1/68-115/67, Landegericht, Aachen.

        • Langston N.
        Toxic Bodies: Hormone Disruptors and the Legacy of DES.
        Yale University Press, New Haven, CT2010
        • Law Commission
        Report on Injuries to Unborn Children.
        Her Majesty’s Stationary Office, London1974
        • Lee F.
        Detecting the unknown in a sea of knowns: health surveillance, knowledge infrastructures, and the quest for classification egress.
        Sci. Context, forthcoming. 2021;
        • Lellinger S.
        Médicaments et effets secondaires: le Mediator et les dérivés de l’amphétamine.
        Bulletin d’histoire et d’epistemologie des sciences de la vie. 2014; 21: 179-190
        • Lellinger S.
        Innovation thérapeutique et accident médicamenteux: socio-genèse du scandale du ben uorex (Mediator®) et conditions de reconnaissance d’une pathologie émergente: les valvulopathies médicamenteuses.
        (PhD thesis) Université de Strasbourg, 2018
        • Lenhard-Schramm N.
        Das Land Nordrhein-Westfalen und der Contergan-Skandal: Gesundheitsaufsicht und Strafjustiz in den ‘Langen Sechziger Jahren’.
        Vandenhoeck & Ruprecht, Göttingen2016
        • Lenhard-Schramm N.
        Contergan und das Arnzeimittelrecht.
        in: Großbölting T. Lenhard-Schramm N. Contergan: Hintergründe und Folgen eines Arzneimittel-Skandals. Vandenhoeck & Ruprecht, Göttingen2017: 135-166
        • Lenhard-Schramm N.
        Der Fall Duogynon: Ein Zweiter Contergan-Skandal?.
        Dtsch. Apoth. Ztg. 2018; 158: 62-68
        • Lindner U.
        Gesundheitspolitik in der Nachkriegszeit: Großbritannien und die Bundesrepublik Deutschland im Vergleich.
        Oldenbourg, München2004
        • Lindner U.
        Sicherheits- und Präventionskonzepte im Umbruch: Von der Gruppenvorsorge zur Individualisierten Medizinischen Risikoprävention für Schwangere.
        in: Lengwiler M. Madarász J. Das Präventive Selbst: Eine Kulturgeschichte Moderner Gesundheitspolitik. Transcript, Bielefeld2010: 229-249
        • Löwy I.
        • Dias Villela Corrêa M.C.
        The ‘abortion pill’ misoprostol in Brazil: women’s empowerment in a conservative and repressive political environment.
        Am. J. Public Health. 2020; 110: 677-684
        • MacDonald M.E.
        Misoprostol: the social life of a life-saving drug in global maternal health.
        Sci Technol Human Values. 2020; 46: 376-401
        • Madarász-Lebenhagen J.
        Perceptions of Health after World War II: Heart Diseases and Risk Factors in East and West Germany, 1945–75.
        in: Fulbrook M. Port A.I. Becoming East German: Socialist Structures and Sensibilities after Hitler. Berghahn Books, New York2013: 121-140
        • Malich L.
        Die Gefühle der Schwangeren: Eine Geschichte somatischer Emotionalität (1780–2010).
        Transcript, Bielefeld2017
        • Marcelis C.
        • Shiva M.
        EP drugs: unsafe by any name.
        in: McDonnell K. Adverse Effects: Women and the Pharmaceutical Industry. Women’s Educational Press, Toronto, ON1986: 11-26
        • Marks H.M.
        Making Risks Visible: The Science and Politics of Adverse Drug Reactions.
        in: Gaudillière J.P. Hess V. Ways of Regulating Drugs in the 19th and 20th Centuries. Palgrave Macmillan, London UK2014: 97-120
        • Marks L.
        Sexual Chemistry: A History of the Contraceptive Pill.
        Yale University Press, New Haven, CT2010
        • Martin M.
        Dépakine, le scandale: Je ne pouvais pas me taire.
        Robert Laffont, Paris2017
        • Méréo F.
        Les Résistantes: 12 femmes qui font bouger la médicine.
        Harper Collins, Paris2019
        • Michaelis J.
        • Michaelis H.
        • Glück E.
        • Koller S.
        Prospective study of suspected associations between certain drugs administered during early pregnancy and congenital malformations.
        Teratology. 1983; 27: 57-64
        • Moebius U.
        Arznei-Telegramm. 1971; 6: 38
        • Murphy M.
        Seizing the Means of Reproduction: Entanglements of Feminism, Health, and Technoscience.
        Duke University Press, Durham, NC2012
      22. Nemec, B., 2020. Unerledigte Anliegen, in: Güttler, N., Rhyner, N., Stadler, M. (Eds.), Cache 01: Gegen-Wissen. Intercom, Zürich, pp. IV/104–IV/105.

        • Nemec B.
        • Moser G.
        Counselling, Risk and Prevention in Human Genetic Early Diagnosis in the Federal Republic of Germany.
        in: Petermann H. Harper P. Doetz S. History of Human Genetics: Aspects of Its Development and Global Perspectives. Springer International Publishing, Cham2017: 367-393
      23. Netzwerk Duogynon, 2019. Die Geschichte, https://duogynonopfer.de/geschichte/.

        • Neubert D.
        Medikamentöse Noxen als Indikation zum Schwangerschaftsabbruch.
        Der Internist. 1978; 19: 304-309
        • Niswander K.R.
        • Gordon M.
        The Women and their Pregnancies: The Collaborative Perinatal Study of the National Institute of Neurological Diseases and Stroke.
        Saunders, Philadelphia, PA1972
        • Nocke W.
        Sind Weibliche Sexualsteroide Teratogen? Rückblick, Zwischenbilanz, Konsequenzen.
        Der Gynäkologe. 1978; 11: 119-141
        • Oakley A.
        The Captured Womb: A History of the Medical Care of Pregnant Women.
        Blackwell, Oxford1984
        • Olszynko-Gryn J.
        Pregnancy Testing in Britain, c.1900–67: Laboratories, Animals and Demand from Doctors, Patients and Consumers.
        (PhD thesis) University of Cambridge, 2014
      24. Olszynko-Gryn, J., 2016. Risky hormones, birth defects and the business of pregnancy testing, Part 1. Perceptions of Pregnancy (22 Nov.), https://perceptionsofpregnancy.com/2016/11/22/risky-hormones-birth-defects-and-the-business-of-pregnancy-testing-pt-i/

      25. Olszynko-Gryn, J., 2017. Drug scandals and the media – the unresolved case of Primodos. Guardian, 22 Mar. 2017.

        • Olszynko-Gryn J.
        Technologies of contraception and abortion.
        in: Hopwood N. Flemming R. Kassell L. Reproduction: Antiquity to the Present Day. Cambridge University Press, Cambridge2018: 535-552
        • Olszynko-Gryn J.
        Pregnancy testing with frogs.
        in: Hopwood N. Flemming R. Kassell L. Reproduction: Antiquity to the Present Day. Cambridge University Press, Cambridge2018: 672
        • Olszynko-Gryn J.
        The feminist appropriation of pregnancy testing in 1970s Britain.
        Women’s Hist. Rev. 2019; 28: 869-894
        • Olszynko-Gryn J.
        Predictor: the first home pregnancy test.
        J. Br. Stud. 2020; 59: 638-642
        • Olszynko-Gryn J.
        • Bjørvik E.
        • Weßel M.
        • Jülich S.
        • Jean C.
        A historical argument for regulatory failure in the case of Primodos and other hormone pregnancy tests.
        Reprod. Biomed. Soc. Online. 2018; 6: 34-44
        • Oreskes N.
        • Conway E.M.
        Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming.
        Bloomsbury, New York2010: 2011
      26. Osten, P., 2011. Contergan-Skandal: Verstümmelt durch eine Arznei. Frankfurter Rundschau (26 Nov.), 22–23.

        • Oudshoorn N.
        Beyond the Natural Body: An Archaeology of Sex Hormones.
        Routledge, New York1994
        • Parle J.
        • Wimmelbücker L.
        ‘These are the medicines that “make” monsters’: thalidomide in southern Africa, 1958–1962.
        Soc. Hist. Med. 2020; 33: 898-923
        • Patel S.
        Methods and management: NIH administrators, federal oversight, and the Framingham Heart Study.
        Bull. Hist. Med. 2012; 86: 94-121
        • Patel S.
        The benevolent tyranny of biostatistics: Public administration and the promotion of biostatistics at the National Institutes of Health, 1946–1970.
        Bull. Hist. Med. 2013; 87: 622-647
        • Paul R.
        • Lempke K.
        Nur noch vier Jahre zu leben.
        Stern. 1978; 33: 8
        • Paul R.
        • Lempke K.
        Tausend Kinder klagen an. Stern. 1978; 79: 178
        • Pavard B.
        The right to know? The politics of information about contraception in France (1950s–80s).
        Med. Hist. 2019; 63: 173-188
        • Prescott H.M.
        The Morning After: A History of Emergency Contraception in the United States.
        Rutgers University Press, New Brunswick, NJ2011
        • Proctor R.N.
        Golden Holocaust: Origins of the Cigarette Catastrophe and the Case for Abolition.
        Stanford University Press, Stanford, CA2012
        • Proctor R.N.
        • Schiebinger L.
        Agnotology: The Making and Unmaking of Ignorance.
        Stanford University Press, Stanford, CA2008
        • Rageth S.
        Medikamentöse Fruchtschäden in der Schwangerschaft.
        Therapeutische Umschau. 1959; 16: 215-221
      27. Ramsey, M. 2021. The Swedish Abortion Pill: Co-Producing Medical Abortion and Values, ca. 1965–1992. Acta Universitatis Upsaliensis, Uppsala.

        • Red
        Verdacht erhärtet.
        Stern. 1979; 51: 13
        • Rübsamen H.
        • Leder O.
        Zu den Ursachen menschlicher Mißbildungen.
        Beitr. Path. Anat. 1955; 115: 348-373
      28. Rudloff, W., 2002. Im Schatten des Wirtschaftswunders: Soziale Probleme, Randgruppen und Subkulturen 1949 bis 1973, in: Schlemmer, T., Woller, H. (Eds.), Gesellschaft im Wandel: 1949 bis 1973. Oldenbourg, München, pp. 347–467.

        • Saiyed M.M.
        • Ong P.S.
        • Chew L.
        Off-label drug use in oncology: a systematic review of literature.
        J. Clin. Pharm. Ther. 2017; 42: 251-258
        • Sanabria E.
        Plastic Bodies: Sex Hormones and Menstrual Suppression in Brazil.
        Duke University Press, Durham2016
        • Sanders J.
        Bendectin on Trial: A Study of Mass Tort Litigation.
        University of Michigan Press, Ann Arbor, MI1998
        • Schappacher N.
        • Oehler-Klein S.
        Siegfried Koller und die neuen Herausforderungen der Statistik im Nationalsozialismus.
        in: Oehler-Klein S. Die Medizinische Fakultät der Universität Gießen: 1607 bis 2007: Personen und Institutionen, Umbrüche und Kontinuitäten. Steiner, Stuttgart2007: 247-262
        • Schardein J.L.
        Congenital abnormalities and hormones during pregnancy: a clinical review.
        Teratology. 1980; 22: 251-270
      29. Schering, 1978. Neues von Schering 27 (Sept. 1978), p. 1. Pharma Präparate, Duogynon 166, Schering Archive Berlin.

      30. Schering, 1982. Produkthistorie Pharma: Duogynon, p. 1. Pharma Präparate, Duogynon XC 1.38/01, Schering Archives, Berlin.

      31. Schulz, K., 2002. Der lange Atem der Provokation: Die Frauenbewegung in der Bundesrepublik und in Frankreich 1968-1976. Campus, Frankfurt a. M.

      32. Setsevits, S., 1981. In dem Ermittlungsverfahren gegen Dr. Hannse u.a. Unpublished manuscript, B Rep. 058 – Staatsanwaltschaft, 1832. Landesarchiv Berlin.

        • Silies E.
        Liebe, Lust und Last: Die Pille als weibliche Generationserfahrung in der Bundesrepublik, 1960–1980.
        Wallstein, Göttingen2010
        • Silverman M.
        • Lydecker M.
        • Lee P.R.
        Bad Medicine: The Prescription Drug Industry and the Third World.
        Stanford University Press, Stanford, CA1992
      33. SKSDGE, 1978. Statement, 22 Feb. 1978, S1 Pharma Präparate, Duogynon 166, Schering Archives, Berlin.

        • Smithells R.W.
        Letter to W.H.W.
        National Archives, London1967
        • Söderfeldt Y.
        Krankheit verbindet: Strategien und Strukturen deutscher Patientenvereine im 20.
        Jahrhundert, Steiner, Stuttgart2020
        • Spranger J.
        Grundzüge der Pädiatrie in Westdeutschland.
        Monatsschr. Kinderheilkd. 2016; 164: 4-7
        • Steinmetz W.
        Ungewollte Politisierung durch die Medien? Die Contergan-Affäre.
        in: Weisbrod B. Die Politik der Öffentlichkeit – die Öffentlichkeit der Politik. Politische Medialisierung in der Geschichte der Bundesrepublik, Wallstein, Göttingen2003: 195-228
        • Stücken C.
        Der Vertuschte Skandal: Ein Pharmakonzern und sein Hormonpräparat.
        Bayerischer Rundfunk, Munich2016
        • Timmerman C.
        Appropriating risk factors: The reception of an American approach to chronic disease in the two German states, c. 1950–1990.
        Soc. Hist. Med. 2012; 25: 157-174
        • Timmermans S.
        • Berg M.
        The Gold Standard: The Challenge of Evidence-Based Medicine and Standardization in Health Care.
        Temple University Press, Philadelphia, PA2003
        • Timmermans S.
        • Leiter V.
        The redemption of thalidomide: standardizing the risk of birth defects.
        Soc. Stud. Sci. 2000; 30: 41-71
        • Tone A.
        Devices and Desires: A History of Contraceptives in America.
        Hill & Wang, New York2002
        • Towghi F.
        Normalizing off-label experiments and the pharmaceuticalization of homebirths in Pakistan.
        Ethnos. 2014; 79: 108-137
        • Tuana N.
        The Speculum of Ignorance: The Women’s Health Movement and Epistemologies of Ignorance.
        Hypatia. 2006; 21: 1-19
      34. Uekötter, F., 2015. Deutschland in Grün: eine zwiespältige Erfolgsgeschichte. Vandenhoeck & Ruprecht, Göttingen.

        • Ujah I.A.O.
        Sexual activity and attitudes toward contraception among women seeking termination of pregnancy in Zaria, Northern Nigeria.
        Int. J. Gynecol. Obstet. 1991; 35: 73-77
        • Ulrich A.
        Der Fall Duogynon: Ein wenig beachteter Medikamentenskandal.
        Deutschlandfunk Kultur. 2016;
        • van de Walle E.
        • Renne E.P.
        Regulating Menstruation: Beliefs, Practices.
        University of Chicago Press, Chicago, Interpretations2001
        • Vargesson N.
        Thalidomide-induced teratogenesis: history and mechanisms.
        Birth Defects Res. C. Embryo Today. 2015; 105: 140-156
        • Voigt F.
        • Goecke T.W.
        • Najjari L.
        • Pecks U.
        • Maass U.
        • Rath W.
        Off-label use of misoprostol for labor induction in Germany: a national survey.
        EBCOG. 2015; 187: 85-89https://doi.org/10.1016/j.ejogrb.2014.11.026
      35. von Schwerin, A., 2009. Die Contergan-Bombe. Der Arzneimittelskandal und die neue risikoepistemische Ordnung der Massenkonsumgesellschaft, in: Eschenbruch, N. (Ed.), Arzneimittel des 20. Jahrhunderts: Historische Skizzen von Lebertran bis Contergan. Transcript-Verlag, Bielefeld, pp. 255–282.

        • Warrack A.J.N.
        Letter to J.
        National Archives, London1966
        • Weeks A.D.
        • Fiala C.
        • Safar P.
        Misoprostol and the debate over off-label drug use.
        Brit. J. Obstet. Gynec. 2005; 112: 269-272
        • Weßel M.
        Primodos – Hormonaalinen raskaustestaus Suomessa.
        Tieteessä Tapahtuu. 2018; 36: 15-22
        • Westermann A.
        When consumer citizens spoke up: West Germany’s early dealings with plastic waste.
        Contemp. Eur. Hist. 2013; 22: 477-498
        • Wicklund S.
        Special report: drugs for two in pregnancy.
        Am. J. Nurs. 1982; 82: 980-981
        • Wolff U.
        Ist die “Reform des §218” gescheitert?.
        Dtsch. Ärztebl. 1978; 6: 317
        • Zander J.
        • Müller H.A.
        Über die Methylandrostendiolbehandlung während einer Schwangerschaft.
        Geburtshilfe Frauenheilkd. 1953; 132: 16-222

      Biography

      Dr Birgit Nemec is a historian of science and medicine at Charité–Universitätsmedizin Berlin, Germany. She is head of the research group, ‘Children at Risk: a History of Science and Society of Pregnancy and Reproduction in West Germany’. As co-lead with Dr Jesse Olszynko-Gryn on the project ‘Risky Hormones’, she is interested in the roles of patients and activists in the negotiation of knowledge and practices in the new history of reproduction. Her first book on the politics of anatomical images ca. 1920, Norm und Reform, was published by Wallstein Verlag in 2020.
      Dr Jesse Olszynko-Gryn is a historian of science, technology and medicine at the University of Strathclyde, Glasgow, where he co-convenes the Disability Research Group. As co-lead with Dr Birgit Nemec on ‘Risky Hormones’, a UK-German collaborative research project, he is working with patient groups to investigate the contested use and regulation of drugs in pregnancy and the risk of birth defects after thalidomide. His first book, A Woman’s Right to Know: Pregnancy Testing in Twentieth-Century Britain, will reconstruct the remarkable transformation of pregnancy testing from an esoteric laboratory tool to a commonplace of everyday life.