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.
Highlights
A few years ago, the discovery of previously inaccessible archival records in London and Berlin revitalized the longdormant campaign
Led by patient-activist Marie Lyon, ACDHPT is today supported by Gregory Abrams Davidson Solicitors and an All-Party Parliamentary Group chaired by Labour MP Yasmin Qureshi
Based on archival research in several countries, we build a historical argument for apparent regulatory failure on the part of Commission on Human Medicines (CHM)'s predecessor organizations: the Committee on Safety of Drugs (1963–1970) and the Committee on the Safety of Medicines (1970–2005)
Summary
Today's home tests are ubiquitous retail objects that can be purchased cheaply from any pharmacy, supermarket or online. The CSD was tasked with reviewing data submitted by pharmaceutical companies, and with advising manufacturers and the Government on whether new drugs had been adequately tested for market. It had no legal powers and depended on voluntary cooperation from industry. Publicity, he later argued, would have ‘shown doctors the value of reporting adverse drug reactions and our reporting system would have got off the ground much quicker than it did’ (Tansey and Reynolds, 1997: 125). ‘Forty years after thalidomide’, he later wrote in his memoirs, there had been ‘no appreciable progress in the United Kingdom in the detection of druginduced birth defects’ (Inman, 1999: 106)
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