Hormone Pregnancy Tests

Drugs containing synthetic versions of progesterone and oestrogen were taken as a form of pregnancy test from the late 1950s until 1970s; the most commonly used of these in the UK was Primodos. Concerns have been expressed for many years that these hormone pregnancy tests may have caused fetal abnormalities and miscarriage. In 2014, the then Minister for Life Sciences, George Freeman, announced that the Commission for Human Medicines would establish an expert working group to look at the evidence relating to hormone pregnancy tests.

Following this review, the Commission on Human Medicines expert working group published a report of its findings on hormone pregnancy tests in November 2017. This concluded that:

Following this extensive and rigorous review the overall conclusion, based on the totality of the available data, is that the scientific evidence does not support a causal association between the use of HPTs such as Primodos and birth defects or miscarriage.[1]

The report sets out a number of recommendations for the evaluation and reporting on the safety of medicine use in pregnancy.

The Government have said that the report presents the findings of a thorough review of all the relevant evidence. Departmental Ministers have accepted the conclusions and recommendations. However, the report has received criticism following publication, from campaigners in this area, such as the Association for Children Damaged by Hormone Pregnancy Tests, and from MPs in an Urgent Question to the Minister. It has been labelled as a ‘whitewash’ and there have been calls for a statutory inquiry to review the evidence and to consider whether there were regulatory failures.

The debate is likely to focus on the expert working group report. In the application to the Backbench Business Committee, Sir Mike Penning raised a number of concerns about the recently published report, including that it did not look at a ‘possible association’ between the drug and the fetal abnormalities set out in the terms of reference but instead, made its conclusions on a ‘causal association’ and that it did not look at regulatory issues.[3]

More information is provided in the motion for the debate:

That this House regrets that the terms of reference for the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests were to consider evidence on a possible association between exposure in pregnancy to hormone pregnancy tests and adverse outcomes in pregnancy, but the Commission’s Report concluded that there was no causal association between the use of hormone pregnancy tests and babies born with deformities between 1953–1975, even though it was not asked to find a causal link; believes that the inquiry was flawed because it did not consider systematic regulatory failures of the Committee on Safety in Medicines and did not give careful consideration to the evidence presented to it; and calls on the Government, after consultation with the families affected so they have confidence in the process, to establish a statutory inquiry under the Inquiries Act 2005 to review the evidence on a causal association between hormone pregnancy tests on pregnancies and to consider the regulatory failures of the Committee on Safety in Medicines.

This briefing provides background information on hormone pregnancy tests, an overview of the working group review and responses to the report

[1] Commission on Human Medicines, Press release: Independent Expert Working Group finds totality of scientific evidence does not support a causal association between the use of hormone pregnancy tests and birth defects, 15 November 2017

[2] HC Written Question 114880: Hormone pregnancy tests, 29 November 2017

[3] Backbench Business Committee, Proposals for backbench debate, 21 November 2017