A historical argument for regulatory failure in the case of Primodos and other ‘hormone pregnancy tests’
| Autor: | Merle Weßel, Jesse Olszynko-Gryn, Cyrille Jean, Solveig Jülich, Eira Bjørvik |
|---|---|
| Přispěvatelé: | Apollo - University of Cambridge Repository |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Cultural Studies
Pregnancy test Medical Ethics History Health (social science) drug safety lcsh:QH471-489 History of Ideas Archival research Medicinsk etik activism 03 medical and health sciences 0302 clinical medicine Argument RA0421 Political science Health care lcsh:Reproduction 0601 history and archaeology 030212 general & internal medicine Closure (psychology) lcsh:Social sciences (General) Primodos Health policy business.industry health policy 06 humanities and the arts Public relations 3. Good health birth defects 060105 history of science technology & medicine Reproductive Medicine D1 Idé- och lärdomshistoria lcsh:H1-99 pregnancy teratogenicity business Medical ethics Developmental Biology |
| Zdroj: | Reproductive Biomedicine & Society Reproductive Biomedicine & Society Online, Vol 6, Iss, Pp 34-44 (2018) |
| ISSN: | 2405-6618 |
| Popis: | The drug Primodos and other hormone pregnancy tests (HPTs) remained on the British market for about a decade after they were first implicated, in 1967, as a possible cause of birth defects. In November 2017, an expert working group (EWG) set up by the Medicines and Healthcare Products Regulatory Agency (MHRA) concluded against such an association. However, it was explicitly ‘not within the remit of the EWG to make formal conclusions or recommendations on the historical system or regulatory failures’, a situation that has left many stakeholders dissatisfied. Placing the question of a teratogenicity to one side, this article takes a more contextual and comparative approach than was possible under the auspices of MHRA. It asks why an unnecessary and possibly even harmful drug was allowed to remain on the British market when a reliable and perfectly safe alternative existed: urine tests for pregnancy. Based on archival research in several countries, this article builds a historical argument for regulatory failure in the case of HPTs. It concludes that the independent review which campaigners are calling for would have the potential to not only bring them a form of closure, but would also shed light on pressing issues of more general significance regarding risk, regulation and communication between policy makers, medical experts and patients. Keywords: activism, birth defects, drug safety, health policy, pregnancy, teratogenicity |
| Databáze: | OpenAIRE |
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