Expert Working Group report on 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 congenital anomalies 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.

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]

In February 2018, the then Secretary of State for Health and Social care, Jeremy Hunt announced the establishment of a medicines and medical device safety review. This review is chaired by Baroness Cumberlege, and is looking at three issues of concern, including the use of Primodos, the hormone pregnancy test. The review has started to take evidence from patients, patient groups, healthcare professional and others.

A new systematic review of the evidence on hormone pregnancy tests was published in November 2018. The authors have concluded that that “the use of oral HPTs in pregnancy is associated with increased risks of congenital malformations.”[3] The Government have said that the Commission on Human Medicines has convened an Expert group to look at the new study.

The report sets out a number of recommendations for the evaluation and reporting on the safety of medicine use in pregnancy. The Government said that the report presents the findings of a thorough review of all the relevant evidence. Departmental Ministers accepted the conclusions and recommendations.[2] However, the report received criticism following publication, from campaigners in this area, such as the Association for Children Damaged by Hormone Pregnancy Tests, and from MPs in Parliamentary debates. It was labelled as a ‘whitewash’ and there were calls for a statutory inquiry to review the evidence and to consider whether there were regulatory failures.

In February 2018, the then Secretary of State for Health and Social care, Jeremy Hunt announced the establishment of a medicines and medical device safety review. This review is chaired by Baroness Cumberledge, and is looking at three issues of concern, including the use of Primodos, the hormone pregnancy test. The review has started to take evidence from patients, patient groups, healthcare professional and others.

A new systematic review of the evidence on hormone pregnancy tests was published in November 2018. The authors have concluded that that “the use of oral HPTs in pregnancy is associated with increased risks of congenital malformations.” The Government have said that the Commission on Human medicines has convened an Expert group to look at the new study.

[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] Heneghan C, Aronson JK, Spencer E et al. Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis [version 2; peer review: 3 approved]. F1000Research 2019, 7:1725 (https://doi.org/10.12688/f1000research.16758.2)