Hormone Pregnancy Tests

Debate between Emma Reynolds and Jackie Doyle-Price

Tuesday 23rd April 2019 Westminster Hall

[Jackie Doyle-Price]

I am answering on behalf of the working group. That is an independent process and I will try to do my best. The right hon. Gentleman raises the issue of the meta-analysis and the suggestion that Parliament has been misled about why that was not done. The expert working group discussed the merits of doing a meta-analysis at its fifth meeting. In its view, the studies were very different, not sufficiently robust and suffered from extensive limitations. The group concluded that conducting a meta-analysis was not the most appropriate way to analyse this type of study. Instead, the group developed a set of quality criteria and presented its assessment of each study in a series of plots. To reconfirm, the data was not considered sufficiently robust for meta-analysis to be used. One of the real problems we have is that we are talking about data that, as we have mentioned, is 50 years old and not sufficiently robust.

There have been some suggestions that the expert working group has been less than transparent. In line with the Government’s commitment to publish the report of the review and all the evidence considered by the group, all documents have been available for public scrutiny since November 2017. We have been very grateful for the involvement of Marie Lyon throughout that process.

There has been some criticism of the lack of an external peer review of the expert working group report. The Government’s independent scientific advisory body on the safety of medicines, the Commission on Human Medicines, acts as the peer reviewer for all expert working groups. It reviewed the draft report on two occasions before it was published. I know that Baroness Cumberlege will be looking at whether there has been sufficient peer review of that report, and I look forward to receiving her recommendations. As with any issue, new evidence can emerge in the meantime. I reassure the House that the Government have made a commitment to review any important new evidence, and we have honoured that commitment.

[Emma Reynolds]

The Minister said a moment ago that the crux of the matter is what was known at the time about the balance of risks. Will she look at international comparisons? In other countries, this hormone pregnancy test was banned much earlier than it was in the UK.

[Jackie Doyle-Price]

I hear what the hon. Lady says. We have taken this work forward with the working group and have been looking at the totality of evidence around the world, particularly in Europe. Last year, Ministers asked the MHRA to convene a group of experts who have been completely without any agenda on this issue in the past, to consider the work by Professor Vargesson and ensure that it was sufficiently independent. That work, which has been referred to, concluded that Primodos caused malformations in zebrafish embryos. We have also asked for an independent European-level review of that evidence to be undertaken, so that everyone can have more confidence in the outcome. Both the UK and European reviews concluded that the results of the zebrafish study had no implications for the conclusions of the expert working group’s report, and the findings of both reviews have been published.

I turn finally to the data published by Professor Heneghan. Although this analysis does not contain any new data, it found the use of hormone pregnancy tests in pregnancy is associated with a small increased risk of certain congenital malformations. The Government have therefore asked for a completely new expert group to be convened in order to consider Professor Heneghan’s work, and for a review to be conducted in parallel with the European review. Those reviews are ongoing, and I look forward to receiving that advice.

I appreciate that I have not been able to satisfy all the representations made by right hon. and hon. Members this morning. As I said, the Government will continue to review evidence in this area. We are still considering the evidence from Professor Heneghan, and we look forward to implementing any recommendations that Baroness Cumberlege brings forward in this regard.