Hormone Pregnancy Tests — House of Lords, 2017-11-16
Topic: Health
James O’Shaughnessy (Conservative, Centre-right): My Lords, with the permission of the House, I shall repeat as a Statement the response to an Urgent Question given by my honourable friend the Parliamentary Under-Secretary of State in the other place on hormone pregnancy tests. The Statement is as follows: "Yesterday, the Commission on Human Medicines published the report of its expert working group on hormone pregnancy tests. As I said at Health Orals on Tuesday, Mr Speaker, this subject demands the utmost sensitivity and I will do my best Based on its extensive and thorough review, the expert working group’s overall finding, endorsed by the Commission on Human Medicines, is that the available scientific evidence, taking all aspects into consideration, does not support a causal association between the use of hormone pregnancy tests such as Primodos during early pregnancy, and adverse outcomes of pregnancy with regard to miscarriage, stillbirth or congenital abnormalities. Ministers have accepted the advice of the Commission on Human Medicines and a Written Ministerial Statement was published yesterday, along with a copy of the report In the UK, hormone pregnancy tests first became available for diagnosing pregnancy in the 1950s. Between then and 1978, when Primodos was withdrawn from the market in the UK, a number of studies were published which investigated a possible link between women being given a hormone pregnancy test to diagnose pregnancy and the occurrence of a range of congenital anomalies in their babies. Although there was never any reliable evidence that HPTs were unsafe, concern about this issue, coupled with the development of better pregnancy tests, meant that a number of precautionary actions were taken to restrict the use of HPTs. The tests were voluntarily removed from the market by the manufacturers The body of information subsequently accrued by the Association for Children Damaged by Hormone Pregnancy Tests and other campaigners led to a parliamentary debate in Westminster Hall in 2014 during which the then Minister for Life Sciences stated that he would instruct that all relevant documents held by the Department of Health be released. In addition, he determined that an independent review of the papers and all the available evidence was justified The purpose of the review was to ascertain whether the totality of the available data, on balance, supported a causal association between use of a hormone pregnancy test by the mother and adverse pregnancy outcomes. It also considered whether, alternatively, the anomalies could have been due to chance alone or to other factors. The final report summarises the scientific evidence that was considered by the expert working group, its conclusions on that evidence, and its recommendations. All the available relevant evidence on a possible association has been extensively and thoroughly reviewed with the benefit of up-to-date knowledge by experts from the relevant specialisms. The evidence reviewed by the expert group will be published in the new year, once it has rightly been checked in line with the legal duties of data protection and confidentiality. In addition to the overall conclusion, the expert working group has made a number of recommendations to safeguard future generations through strengthening the systems in place for detecting, evaluating, managing and communicating safety concerns with use of medicines in early pregnancy While I recognise the conclusion of the report will be a disappointment to some, I hope they will see the recommendations as positive. They are a credit to the efforts of the Association for Children Damaged by Hormone Pregnancy Tests and the All-Party Parliamentary Group on Hormone Pregnancy Tests, which I know the honourable lady chairs, and a lasting legacy".