Medicines, risks, and crises. Towards a history of health problems associated with the use of medicines, 1900-2023

Medicines, risks, and crises. Towards a history of health problems associated with the use of medicines, 1900-2023

Organisatoren
Joséphine Eberhart, Université Paris-Dauphine; Solène Lellinger, Université de Strasbourg; Nils Kessel, Université de Strasbourg
Ort
Paris
Land
France
Fand statt
In Präsenz
Vom - Bis
21.03.2024 - 22.03.2024
Von
Mahaut Bouchez, Université de Strasbourg

The primary objective of this conference was to adopt a historical lens on events and risks linked to medication use, contextualizing them within socially identifiable practices.

The first session called ‘Testing risk’ allowed to broach on the one hand the topic of security and efficacy challenging of medicines, and on the second hand, the intertwined relationship between evaluation, marketing, and regulation within the pharmaceutical industry. FRANSCISCO JAVIER MARTINEZ (Zaragoza), investigates the lesser-known story of Bayer's trials testing a drug called Plasmoquin against malaria that proved to be more harmful than beneficial to patients. Over the course of five years, the government conducted over 400 tests on populations who did not provide consent and launched a mass campaign from 1929 to 1931, suggesting a prioritization of business interests over public health concerns. MAUD BERNISSON (Nijmegen), presented her research on the formalization of the relationship between the pharmaceutical industry and the medical writing industry. She investigated Mallinckrodt's collaboration with subcontractors during the 2010s. They engaged in the production of misleading content and marketing on the firm's opioid products risks, using experts to target prescribers and users, without disclosing the information's origin, a practice referred to as "ghostwriting" (Sergio Sismondo). CAROLINE SCHEP (Leiden), delved into the historical context of drug testing in the Dutch East Indies between 1901 and 1933. The presentation prompted reflection on doctor-patient negotiation and ethical considerations in using colonies as experimental grounds. JOSEPHINE EBERHARDT (INRAE, France), explores the dynamics surrounding the removal of Di-Antalvic from the market, a popular pain-management medicine which faced scrutiny due to grave adverse effects. Putting deaths into numbers proved to be a different exercise depending on the representation each country had of the medicine. As data was very variable, the primary determinant in the decision-making process was its effectiveness, which led to its suspension. This case underlines the imperative for robust vigilance in assessing the safety and efficacy of pharmaceuticals throughout their lifecycle, particularly in light of evolving scientific understanding and societal expectations regarding healthcare standards. This session highlighted the contrasting approaches between population-centric and individual-centric healthcare practices, revealing the ethical complexities involved.

The second session was themed around gender and uncertainty, and included researches about sanitary scandals and patients’ status of victim. SOPHIE WAGEMANN (Leipzig), showed how the pill’s risk assessment is inherently gendered, with side effects initially dismissed as psychosomatic symptoms, shedding light on how studies categorized gender into simplistic binaries, overlooking the complex realities individuals. ALMIRA SHARAFEEN (Munich) investigated the experiments in childbirth pain relief led in URSS in order to demonstrate the quality of care under this regime. In a context of shortages of drugs and personnel, the URSS encouraged a mass campaign of anaesthesia during childbirth. It also served to discipline the population, coercing women to accept anaesthesia and physicians, who faced repression. RAFAEL COSTA (Paris), discussed Ondogyn, a hormonal replacement therapy. Findings on associated higher risks resulted in a decline in prescriptions in Europe and the US, with varying reductions influenced by national differences in risk perception and medical practices, highlighting gendered constructions in medication management. Finally, JESSE OLSYNKO-GRYN and BIRGIT NEMEC (Berlin) presented research on the Softenon scandal. Integrating victims' narratives and personal archives, their work underlines the emotional complexities of medicine victims, such as guilt, responsibility, and loss of trust in science.

In the roundtable discussion, MICHEL TOURNAIRE (Paris), gynecologist, discussed the Distilbene case, a medication prescribed to prevent miscarriages that resulted in cancers, generational malformations, and pregnancy complications. In the US, a solidarity fund compensated victims, while in France, the drug was contraindicated during pregnancy following Anne Cabau’s alerts. Michel Tournaire emphasized the importance of scientific expertise in activism for victim support and legal ramifications. MARINE MARTIN, French whistle-blower for the risks of anti-epileptic medication during pregnancy, APESAC President, shared her journey as a Dépakine victim. Motivated by the Mediator case, she recognized the power of media attention in alerting potential victims, leading her to establish her association to facilitate information dissemination and engage in counter-expertise activities. She advocates for improved regulation to ensure pregnant women are fully informed about treatment risks. LUCILE RUAULT, researcher at the CNRS, presented her research on the Women's Health Movement of the 1970s, focusing on self-practiced gynaecology as a means of reclaiming their bodies and producing counter-expertise in response to distrust of medical communities. SYLVIE OLLITRAUT, researcher at the CNRS/EHESP, reminded the underrepresentation of women in medical research and highlighted the tendency in sociology to focus on traditional gender roles. She pondered on how to get out of this paradigm, suggesting that awareness and reflexivity were a starting point.

The third session demonstrated that mass medicine distribution and the production of epidemiological data encompass more than just issues related to access to care. LOLA WILHELM (Geneva) explored the role of penicillin in combating venereal diseases in the 1960-1970s, particularly syphilis, and highlighted how the World Health Organization (WHO) allocated a significant portion of its budget to this cause. While official recommendations evolved with the introduction of penicillin, practices varied across regions, leading to divergent outcomes such as a surge in syphilis prevalence in French West Africa but a decline in America. Penicillin did not act as a universal cure as expected, instead posing geopolitical and colonial challenges. IRINA NASTASA-MATEI (Bucharest) explored how, under Ceausescu's regime, production of medicines became intertwined with politics. Polidin vaccine represents this dynamic, as a heavy propaganda exerted pressure on physicians to prescribe it. She highlighted the belief in the Polidin vaccine as a cure-all. This presentation enhanced the significance of health policies as tools of authority for government since it enables engagement with every aspect of society, as public health justifies launching extensive and massive campaigns that reach every individual. To continue the discussion on perceptions regarding vaccines, CECILE LAVIER (Paris) discussed how responsibility was shifted to avoid controversies amid public mistrust in vaccinations against sexual risks. Consequential to criticism relative to Hepatite B vaccine’s campaign, the government reversed the vaccination responsibility onto the medical corps, facing criticism from healthcare professionals. In this session, issues of mass production, access to healthcare, and decision-making in public policy were discussed. These approaches helped shedding light on the interaction between disease control strategies and policies and societal structures.

The fourth and fifth sessions focused on the risks and alternatives to answer them. GERMAINE BIENVENUE NYANE (Maroua) explored how the resurgence of tuberculosis in Lake Chad Basin motivated initiatives by both associations and the government. She also delved into the role of traditional medicine, which serves not as a competitor but rather as a complementary approach in tuberculosis treatment, as it garners trust from the population. LUCILE BENOÎT (Paris) examined the growing demand from animal owners, especially in farm settings, to reduce antibiotic usage in animals destined for human consumption due to public health concerns surrounding antibiotic resistance. She discussed the complexities of classifying phyto-aromatherapy products, involving the use of plants and essential oils in animal care, amidst regulatory debates over their categorization as medicines or dietary supplements. LEO BERNARD (IFRIS, France) dispensed a historical and critical analysis of the risks associated with chemical medicine from a naturopathic perspective in France between the 1950s and 1980s. He highlighted the post-World War II influence on the naturist movement, particularly through publications advocating a return to nature. Risk and its social acceptability lie at the core of the issue: while advocates of the naturist approach resist the idea of risking medication ingestion, health industry stakeholders and health regulators would rather see them take on this risk. MIRIAM LIPTON (Corvallis (Oregon)) highlighted how, during the Cold War, antibiotics were seen as revolutionary in reducing the risk of infectious diseases and prolonging lifespans, while soviet microbiologists oriented their research on alternatives, bacteriophages. The USSR was facing severe shortages of antibiotics and needed to provide official justification. There was a political and ideological imperative to present a solution to infectious diseases. ACHILLE BERENGER NGO ISSOCK FOE (Yaoundé), explored the transition during the colonial era from traditional medicines to biochemically produced drugs. A means of providing healthcare eventually became harmful due to proliferation of counterfeit and unapproved medications. Authorities, both colonial and then governmental, remained silent in addressing this poisoning phenomenon, particularly affecting impoverished populations.

CHRISTELLE RATIGNIER-CARBONNEIL, the National Agency for Safety of Medicines and Health products (ANSM) managing director, emphasized the dynamic nature of the balance between benefit and risk associated with medications, which evolves based on scientific and clinical knowledge. The concept of risk is not binary but is rather a continuum changing over time with use and experience. The importance of regulatory authorities in responding to crises and ensuring public safety was underlined, particularly in light of the evolving nature of health agencies in response to sanitary crises. She presented the key principles for managing uncertainty: ongoing monitoring, stakeholders involvement, and transparency in decision-making. She concluded by saying how adapting to societal expectations while educating about the role of medications and addressing potential risks is crucial for maintaining public trust. PIERRE CHIRAC, for the independent Journal Revue PRESCRIRE presented the various actors playing a role in improving the benefit-risk balance to avoid preventable risks: the political authorities, the drug regulatory agencies, pharmaceutical companies, healthcare practitioners/patients, and advocacy / patients groups. MATHIEU RESCHE-RIGON (Paris), conducted in the past clinical trials in oncology and early phases, focusing on severe adverse drug reactions, which are particularly sought after in early phases of drug testing. He raised concerns from increasing pressure from pharmaceutical companies, colleagues, and patients for faster clinical trials and market approvals, which contradicts the precautionary principle. There is also concern about the declining interest in randomized clinical trials, which allow for proper group comparability and assessment of adverse effects risk. IRENE FRACHON (Brest), and whistle-blower for the Mediator case, started by show her concern about the Mediator scandal being often excessively cited to justify various stances questioning medical rationale. She recalls a 1993 meeting, documented in a recently discovered report, where it was disclosed that the Medicines Agency, in collaboration with Servier, admitted to serving the interests of the firm, thereby prioritizing economic considerations over public health concerns. It highlights the delicate balance between acknowledging the existence of conspiracies and recognizing that not all incidents involve such plots. She sees medicines security as a continuous work, where influence plays should be controlled. Along the same lines, CHRISTIAN BONAH (Strasbourg) recognized medicines safety to be not solely a goal to achieve a certain state but rather a continuous work from various entities. According to him, blaming individuals, entities or systems can lead to scapegoating, although exemplary trials can be beneficial. Victims consistently demand "never again" indicating the persistent historical depth of safety issues. He concluded by explaining how regulation aims to balance patient safety and market control, with periods of precaution varying over time.

Two keynote-talks were also delivered. DAVID HERZBERG (Buffalo) delved into the commercial and determinants of health in the US opioid markets, exploring the historical details of the opioids crisis in the US. YLVA SÖDERFELDT (Uppsala) looked at the development of patient’s organisations in the healthcare sector in Germany, Sweden, France and the UK, intertwined with the pharmaceutical industries.

In conclusion, this conference underscores the complex interplay of social, cultural, and political factors in shaping the acceptability of risk within healthcare decision-making processes. It highlights the dynamic nature of risk-benefit evaluations and emphasizes the necessity of ongoing study to ensure patient welfare. Access to comprehensive and understandable information is essential for informed consent. Moreover, the association of the pharmaceutical industry with profit-seeking motives prompts further inquiry into the practices within pharmaceutical companies and their impact on patient care.

Conference overview:

Session 1: Testing risk

Francisco Javier Martinez (Zaragoza): Testing grounds: Bayer’s Plasmochin trials in Spain and Spanish Morocco, 1925-1928

Maud Bernisson (Nijmegen): The formalisation of the relationships between the pharma industry and the medical writing industry

Caroline Schep (Leiden): A colonial laboratory? Drug test reports in the Geneeskundig Tijdschift voor Nederlandsch-Indië, 1901-1933

Josephine Eberhart (INRAE): Counting Di-Antalvic deaths. European Controversies surrounding the removal of the star of pain relief medications from the market

Keynote talk

David Herzberg (Buffalo): Commercial and carcoeral determinants of health in US opioid markets

Session 2: Gendering uncertainty

Sophie Wagemann (Leipzig): Explaining side-effects: hormonal methods of contraception and holistic tendencies in German gynaecology

Almira Sharafeeva (Munich): The joy of painless motherhood: a Soviet experiment without precise instructions

Rafel Costa (Paris): Menopause hormonal treatment and medication risks perception

Jesse Olsynko-Gryn/Birgit Nemec (Berlin): Stories of Disability, Guilt, and Perseverance: using oral History to Reconsider a Transnational Drug Scandal from the Perspectives of Patient-Campagners

Round table discussion: Rights and risks: Health activism, its gender and its practices

Michel Tournaire (former head of the gynecology-obstetrics department at Hospital Saint-Vincent-de-Paul, Paris) / Marine Martin (Association to help parents of children suffering from anticonvulsant syndrome) / Lucile Ruault (CNRS) / Sylvie Ollitrault (CNRS / EHESP)

Keynote talk

Ylva Söderfeldt (Uppsala): Pharma industry and Patient Organizations: History of a Precarious Alliance

Session 3: Governing disease and medicines

Lola Wilhelm (Geneva): Mistrust and misuse: Penicillin in the International Programs for the Eradication of Treponematoses in French West Africa, 1950-1970.

Irina Nastasa-Matei (Bucharest): Pharmaceuticals and Politics. The Polidin Vaccine in Communist and Post-Communist Romania

Rodrigue Marcellin Piaplie Njimfo (Yaoundé): The fight against onchocerciasis through the Distribution of Ivermectin in Cameroon and the Development of severe side effects in Forst communities where loiasis is co-endemic, 1990-2020 (presentation was cut short due to technical difficulties)

Cécile Lavier (Paris): Shifting risks to avoid controversies : the Ministry, the singular consultation, and vaccinations against sexual risks (1990-2023)

Session 4: Risks, environments and species

Bienvenue Germaine Nyané (Maroua): Climate change and human diseases in the Lake Chad Basin: The case of Tuberculosis

Lucile Benoît (Paris): Rethinking the Regulation Methods of Phyto-Aromatherapy in Veterinary Medicine

Session 5: Alternatives?

Léo Bernard (IFRIS): “Errors, dangers, and abuses of chemical Medicine: Documentation and Naturist Critiques of Medication Risks (France, 1950-1980)

Miriam Lipton (Corvallis (Oregon)): the Antibiotic: Soviet Rejection of Antibiotics in Favor of alternatives

Achille Bérenger Ngo Issock Foe (Yaoundé): Counterfeit Drugs and Street Pharmacization: Processes of Poisoning Cameroonian Populations in the context of Colonial Poverty to 2023

Conclusion roundtable discussion: Medicines Security

Christelle Ratignier-Carbonneil (Manager, National Agency for Safety of Medicines and Health products) / Pierre Chirac (Medical Journal Prescrire) / Mathhieu Resche-Rigon (University Paris-Cité) / Irène Frachon (Pulmonologist and whistle-blower for the Mediator Case) / Christian Bonah (University of Strasbourg)