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Hormone Pregnancy Tests

Volume 785: debated on Thursday 16 November 2017


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 Between then and 1978, when Primodos was withdrawn from the market in the UK, a number of studies were published which investigated a possible link between women being given a hormone pregnancy test to diagnose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”.

My Lords, I thank the Minister for repeating the Statement. I realise that the House is working him hard today, but he has the comfort of a huge department to provide his brief for him. In some ways, that underlines the dilemma that he and the Government face on this issue. This report has caused such dismay and disbelief among campaigners, and every MP who spoke in the Commons, that it requires the Government to use their critical faculties, listen to what is being said across the piece and look again at the report, its genesis and its lack of transparency.

I have two questions. First, will the Minister explain why Marie Lyon was told:

“I could go to prison if I divulge what was discussed”?

Does he agree that that is about as far away from transparency as it is possible to get?

Secondly, the draft of the report, which was published in October, stated that:

“Limitations of the methodology of the time and the relative scarcity of the evidence means it is not possible to reach a definitive conclusion”.

That sentence was removed from the final version. Why was it removed, why was there a delay of a month and did the Minister speak to the authors of the report about the sentence before its removal?

I thank the noble Baroness for her questions. The most important thing to stress is that this report was the product of an expert working group of scientists and included an independent member in Nick Dobrik, who is a noted thalidomide campaigner and certainly not a government yes man. The chair of the families group, Mrs Lyon, was an observer. We are beholden to take the evidence of those who are best qualified and who have given their view on what link there may or may not have been between these pregnancy tests and the abnormalities. The conclusion they have come to is that, in their view, there is no causal association on the basis of the evidence they were able to consider.

The noble Baroness asked about transparency. Every single member of the expert working group signed a confidentiality agreement. That is common to all such groups in the Commission on Human Medicines. Mrs Lyon was not alone in that. That expires at the point of publication, so she is now absolutely free to say whatever she wants, as indeed is any other member. I can reassure her that there was no particular or unusual treatment for her compared to other members of the panel or to other panels that have operated in similar ways. The minutes of all the meetings will be published. As the Statement pointed out, the full evidence set will also be published, once it has gone through due diligence.

Changes to the draft were suggested by the Commission on Human Medicines and accepted by the expert working group. There was no interference from me or anyone else—it was a discussion between those two bodies. The report was unfortunately delayed. That was in order to make sure that it was as clear and as digestible as possible for non-experts. I think the report is a very thorough and comprehensible piece of work. I recognise that it is not the response that families were looking for. In some cases, they have experienced horrendous events—they have either lost babies or, in some cases, their children have extremely severe deformities—but I come back to the point that the task of the group was to look at whether there was a causal association. The group had scientific expertise. It has given its advice, and we are following it and the recommendations that it made.

My Lords, how do the Government intend to restore the trust and confidence of those left feeling betrayed by the lack of transparency and openness surrounding this inquiry that the Minister has just talked about?

As I pointed out in response to the noble Baroness, Lady Thornton, transparency is there in the evidence and minutes that will be published. The report that has come out is big and chunky and contains a huge amount of information. There was an independent member in Nick Dobrik, the thalidomide campaigner, and Mrs Lyon, who chairs the families group, was an observer. We touched on confidentiality agreements. As I said, there is nothing out of the ordinary in that. I think transparency is there. I come back to the point that the working group was set up to examine all the available evidence scientifically. The department provided its scientific and non-scientific papers for that effort. I know the report has not come up with the conclusions that the families wanted, but it is the right group to have made that judgment.

My Lords, I understand that the Minister realises the concerns of those families who have been affected. He put the case and described how the inquiry was conducted very clearly but, as has been said, there is still quite significant concern outside this House among Members of Parliament and the families concerned. If we are talking about getting reassurance, perhaps it would be useful to have a proper debate on the findings of the report so that all these aspects can be laid out in greater detail, including the case from the Minister.

I would certainly welcome such a debate. I know that was discussed in the debate in the other place on the Urgent Question. I want to emphasise the seriousness with which I take this issue. I had the opportunity to meet Yasmin Qureshi MP, who chairs the all-party parliamentary group, and Mr and Mrs Lyon in early August. I will be meeting them again in early December. I utterly sympathise with them in the experience they have had, and I understand that there is a need to reassure them that the process that has been followed is a proper process. I accept that, and I am making all the efforts I can to do it.