Hormone Pregnancy Tests

Debate between Steve Brine and Yasmin Qureshi

Thursday 16th November 2017 Commons Chamber

[Yasmin Qureshi (Bolton South East) (Lab)]

(Urgent Question): To ask the Secretary of State for Health to make a statement on the recently published “Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests”.

[The Parliamentary Under-Secretary of State for Health (Steve Brine)]

Yesterday, the Commission on Human Medicines published the report of its expert working group on hormone pregnancy tests. As I said at Health questions on Tuesday, this subject demands the utmost sensitivity and I will do my best.

Based on its extensive and thorough review, the 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 casual association between the use of hormone pregnancy tests, such as Primodos during early pregnancy, and adverse outcomes of pregnancy with regard to either miscarriage, stillbirth or congenital abnormalities. Ministers have accepted the advice of the Commission on Human Medicines. 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 Between then and 1978, when Primodos was withdrawn from the market in the UK, a number of studies that investigated a possible link between women being given a hormone pregnancy test to diagnose pregnancy and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 was published. Although there was never any reliable evidence that HPTs were unsafe, concern about the 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 2014, I think in Westminster Hall, during which the then Minister for life sciences, my hon. Friend the Member for Mid Norfolk (George Freeman), 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 casual 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 other factors.

The final report summarises the scientific evidence that was considered by the expert working group, its conclusions on the 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 working group will be published in the new year, once it has been rightly 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 about the use of medicines in early pregnancy. I recognise that the conclusion of the report will be a disappointment to some, but I hope that 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 group on oral hormone pregnancy tests, which is chaired by the hon. Lady, and also a lasting legacy.

[Yasmin Qureshi]

I am so disappointed with the Minister’s response. Clearly he is just reading what his staff and the Department have been telling him. I wish the Minister would actually go through the documents submitted to the inquiry and those documents that we had, because if he had read them, he would never have to come the Dispatch Box and said what he has said.

You will be aware, Mr Speaker, that I have raised this issue in Parliament on a number of occasions. In 2014, an expert working group was set up to look at a possible association—not a casual link or a causal link. I am sure that hon. Members agree that that means that a lesser burden of proof is required. The first thing that the commission did was to say that it had found no causal connection, but it was never asked to do that—it was asked to look for a possible association. In 2014, the then Minister made promises about statutory oversight. From the papers we had, there appeared to be a clear criminal responsibility regarding the statutory body, the Committee on the Safety of Medicines, and the people who ran it, given that so much evidence was adduced to them. They were alerted to the fact that Primodos was causing deformities and miscarriages in women, but they totally ignored that evidence. In fact, the person in charge actually said that he wanted to cover it up so that nobody could be sued. It is therefore highly surprising that the commission has come up with this recommendation.

The commission was shown evidence from many studies, the majority of which showed conclusively that when the drug was given to rabbits and rats—mammals, like ourselves—the tissues were damaged. There were—