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Abstract：
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.
摘要：
Primodos药物和其他激素妊娠试验（HPT）在首次被牵连后在英国市场上保留了大约十年，1967年，作为出生缺陷的可能原因。2017年11月，由药品和保健产品监管局（MHRA）成立的专家工作组（EWG）反对这样的协会。然而,明确地，“不在EWG的职权范围内，对历史制度或监管失灵做出正式结论或建议”，这种情况使许多利益相关者不满意。将致畸性问题放在一边，本文采用了比MHRA主持下更多的上下文和比较方法。它询问为什么在存在可靠且完全安全的替代方案时，为什么允许在英国市场上保留一种不必要的，甚至可能有害的药物：怀孕的尿液测试。根据几个国家的档案研究，本文为HPT案例中的监管失灵建立了历史论据。它的结论是，竞选者呼吁的独立审查不仅有可能给他们带来一种封闭的形式，但也将揭示与风险有关的更普遍意义的紧迫问题，政策制定者之间的监管和沟通，医学专家和患者。
