Hormone Pregnancy Tests

(Limited Text - Ministerial Extracts only)

Tuesday 23rd April 2019 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

I thank all hon. Members who have participated in the debate, with real passion and determination to get to the truth. I fully accept the perception held by all Members present that we have waited a long time for answers.

One of the reasons I have pushed so hard for the Cumberlege review is exactly those arguments that have been made here this morning. It is important that everybody who has been affected is able to get answers. We have heard lots of talk today about a cover-up, and there clearly needs to be confidence in the review’s outcome. That is why I wanted Baroness Cumberlege to take an objective look at exactly what has happened, as well as recognising that the way in which the regulatory system has dealt with concerns has seemed very inhumane, process-driven and extremely insensitive to patients. The response on issues of patient safety must be improved. I am really looking forward to receiving Baroness Cumberlege’s recommendation in that regard, because so many people’s experiences have been entirely unsatisfactory. I know that she has considered the evidence brought to her by Marie Lyon and Jason Farrell. I will be taking the recommendations extremely seriously and I hope that she can draw some conclusions on where everything has gone wrong.

The hon. Member for Bolton South East (Yasmin Qureshi) and others raised the issue of the independence of the Medicines and Healthcare Products Regulatory Agency. It is entirely appropriate that regulators are funded by the community that they regulate, through fees. That in itself does not lead to questions on the regulator’s independence, but we need to offer some challenge in order to see whether the processes have sufficient integrity in terms of the response on issues of patient safety. I do not think we tackle the question of independence solely by shifting the funding on to taxpayers. It is entirely appropriate that the industry should meet the cost of regulation, but the review will bring some conclusions on whether that medical regulation is operating properly.

While we await the review’s conclusions, we have had the expert working group. It is clear that hon. Members are not entirely confident in the processes and conclusions of that group. To put the work in context, the group gathered evidence from around the world and met seven times over an 18-month period. It concluded unanimously that the totality of the data reviewed did not support a causal association between Primodos and adverse pregnancy outcomes. It also did not conclude that there was not, and we clearly need to consider any further evidence when it is brought forward.

[Hannah Bardell]

I appreciate the comments that the Minister is making. She must recognise that the MHRA had ultimate control over what the expert working group saw, and that many documents that Sky’s Jason Farrell had uncovered in Berlin and which Members have cited were not included in the work of the EWG. We need a fully transparent review—as the right hon. Member for Hemel Hempstead (Sir Mike Penning) said—under oath. Does she agree that that would be sensible?

[Jackie Doyle-Price]

I come back to my opening comments: we brought forward the Cumberlege review to give an independent challenge to what is currently being done by a regulatory system. We need to look at whether that system is appropriate, given the concerns.

[Gordon Marsden]

The Minister is being very generous with her time. She is seeking to persuade us, perfectly reasonably, that she and the Government have been acting in a measured way to try to look into all these things. As I have said, we welcome Baroness Cumberlege’s report. Has the Minister at any time asked the members of the expert working group why they changed the definition that they were given?

[Jackie Doyle-Price]

I am not satisfied that that is actually what happened. When we receive drafts of reports that are circulated to committees, they often go through amendment.

Let me continue going through the chronology of events. As I said, the evidence did not support a causal association, nor did it disprove one. We will of course continue to review evidence as it arises.

[Sir Mike Penning]

I think this is a really fundamental point. I apologise if it seems like I am going to give the Minister a hard time, but I am. They were not asked to look for a causal link; they were asked to look for an association, and we have now seen evidence that they knew it was there. I know what happens when the notes are written for the Minister. They were not asked to look for a causal link, but for an association. They decided among themselves to change what they were supposed to look at, which is why they came out with the results that they did. That is a really fundamental point.

[Jackie Doyle-Price]

I hear what my right hon. Friend says. There has to be some element of cause, otherwise there is no scientific basis for a judgment. I will have to agree to disagree with him on that point.

[Sir Edward Davey]

I have to intervene on the Minister on that point. In many cases, drugs are looked at on the probability of risk, not on causality. Causality is a much stronger test. In science, it is very difficult to prove. If her officials are telling her that about a causal link, they are wrong. I urge her to get separate independent advice on that.

[Jackie Doyle-Price]

The drugs are no longer available because of association, due precisely to that balance of risk. The issue that we are looking at now is to what extent that was understood at the time, and to what extent there is a liability. That is what the group is ready to look at.

[Sir Edward Davey]

The Minister is being very generous with her time. I refer her to the evidence that was in the Berlin archives, which goes back to 1968 and 1969, and to the meta-analysis, which proves that on the balance of probabilities there is no doubt. That became known not this year, but years ago.

[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.