Hormone Pregnancy Tests

Hannah Bardell Excerpts

Tuesday 23rd April 2019 Westminster Hall

[Sir Mike Penning (Hemel Hempstead) (Con)]

It is a pleasure to be involved in this debate, to be part of one of the largest all-party parliamentary groups in the House, and to look after my constituents and speak for them and the others who have been so dramatically affected. They trusted the NHS and the drug company and so thought that the drug they were taking was safe. As was suggested, these ladies went to their GP surgery perhaps because they had missed their period or had some of the other symptoms of pregnancy. It was such an important time in their lives. Often the GP just opened a drawer, gave them the tablets and said, “This will tell you whether you are pregnant or not.” There were no pamphlets and no advice, even though the risks were known to nearly everyone, apart from those ladies who took those tablets.

In this excellent debate, we have touched on a lot of the science. I am not a scientist or a lawyer; I am just a dad who is trying to help out some constituents in this area and as part of the group. In the debate that followed the publication of this so-called independent review, I said that it was a whitewash, but it was not; it was a cover-up, and we have to discover what is being covered up. Is it the legal side of the NHS giving a drug to a woman on its premises when it knew there was not only a risk, but an effect? Is it the drug company having undue influence on the report, the Medicines and Healthcare products Regulatory Agency, the Department of Health and Social Care, or a bit of everything?

I say to the Minister that this is not about this Government, but Governments. The issue was being discussed when I was the shadow public health Minister, not least by thalidomide campaigners. They were supportive of this campaign, and they had to rely extensively on evidence that was there, but that the Government and the drug companies had ignored over the years.

[Hannah Bardell (Livingston) (SNP)]

Is it not the case that we do not need to be lawyers or medical experts to realise that a drug that is 40 times the strength of the contraceptive pill—it was being given in such countries as Germany as an abortive—would surely have profound impacts on unborn foetuses, or children who were born after their mothers had taken Primodos?

[Sir Mike Penning]

No one in this room or anyone listening to this debate could disagree with that, unless they were a lawyer working for the drug company, the Department of Health and Social Care, or perhaps both.

Believe it or not, Mr Hollobone, 70% of me, you and anyone else in the room is the same as a zebrafish. I swim really well, but I did not realise that until this morning. We chuckle, but the point is that the effects of an experiment on zebrafish will be similar to those on a human being. There are many studies, but the link is important. Professor Neil Vargesson’s report in 2018 supported Professor Heneghan’s report. What does that mean? We all know about the disgrace of thalidomide. Through experimentation on zebrafish, it was proven that thalidomide damaged children. We do not want to experiment on humans. It appears that that is exactly what has gone on here. It is obvious that the mechanism of the action of thalidomide is the same as that shown by the Primodos tests. Everybody can read the technical stuff. There was an effect on zebrafish, who share 70% of their genes with humans. Does that mean it could have had an effect on humans? Of course it does; it is not rocket science.

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[Hannah Bardell (Livingston) (SNP)]

It is a pleasure to serve under your chairmanship, Mr Hollobone. I give huge credit to Marie Lyon and all the campaigners from the Primodos group; I have got to know them very well in the four years since I was elected in 2015. I have rarely met a more tireless and dedicated group. The same goes for the hon. Member for Bolton South East (Yasmin Qureshi). She, with her staff, has run the all-party parliamentary group with incredible veracity and determination, and it is a pleasure to be part of that. I also give credit to Jason Farrell of Sky, who recently did a documentary on the impacts of Primodos, shining a light where no one else, frankly, has gone.

I have campaigned for my constituent Wilma Ord and her daughter Kirsteen, who was born deaf and with cerebral palsy. Like so many women, as many Members have mentioned, Wilma believed that the deformities that her child was born with were her own fault. Let us call it out for what it is. As the right hon. Member for Kingston and Surbiton (Sir Edward Davey) said, there was a criminal cover-up. Some 1.5 million women were treated as human guinea pigs for the pursuit of profit by the company Schering, now Bayer. I hope that it is listening today.

I know that the Minister and the Government are listening. There is clearly consensus, the likes of which few of us will have seen, across the House on this issue. We are not going away, the campaigners are not going away, and this issue is not going away. Until I am no longer the elected Member of Parliament for Livingston, I will campaign on this issue and pursue it, as I know everybody in the Chamber will.

[Jonathan Reynolds (Stalybridge and Hyde) (Lab/Co-op)]

I, too, am pleased that this debate is happening, but I am really sad and frustrated to be here. I have re-read my speech from our October 2016 debate, at which I think all hon. Members in this Chamber were present. I spoke about two constituents who had been affected.

Most of the speeches in that debate articulately raised such cases, but basically they were asking for a process to find answers. Three years later, we have fewer answers and most of us are more suspicious and angry. On that basis alone, this cannot be the end of the matter. I thoroughly agree with the hon. Lady’s comments.

[Hannah Bardell]

I absolutely agree. I share the hon. Gentleman’s despair and sadness that we are in this position so many years after the group was set up—a process into which the Government put public money and in which medical experts took part. As I have said, we are not necessarily criticising the people in the expert working group, who are medical professionals, but they have fallen victim to a process that was at best opaque and at worst corrupt, given the influence of the companies involved.

Who knows why we ended up in this mess? On the day the report was due to be published, the hon. Member for Bolton South East and I went to an event that we thought was supposed to be public—or at least open to Members of Parliament. We were stopped at the door; some of the press were allowed in, but we were not. We know that there was due to be a press conference and a public event, but they were both cancelled.

Members have spoken passionately about the lack of independence and impartiality, the gagging clause that Marie Lyon had to sign and the heavy-handed approach taken, all of which have caused serious concerns. What does it say to those in the medical community who may be invited to be part of future Government working groups that a group that was supposed to be open and transparent and get to the truth of an issue has turned out to be a cover-up? It raises serious concerns that their credibility will be called into question. That is a very dangerous situation.

As well as looking at the wider issue, we need to look at the mess that the expert group became, so that we can give confidence not only to the families and to our constituents, but to medical professionals.

[Gordon Marsden]

The hon. Lady points out precisely the contextual things that we need to learn. Does she agree that there seems to have been an element of Jekyll and Hyde in the Government’s approach over the past three years? On the positive side, I have confidence that Baroness Cumberlege—with whom I have served on another all-party group—and her team are moving in the right direction. However, everything in the statement that the then Secretary of State made in February 2018 was about the future:

“drive forward…the recommendations of the expert working group…offering the families…a full and up-to-date genetic clinical evaluation…better training and support for obstetricians”.—[Official Report, 21 February 2018; Vol. 636, c. 165-166.]

Those are all good things, but they do not address the past 40 years, offer an apology or express any sense of regret, nor do they address any of the issues raised in this debate. Would it not be a good idea for the Minister to go back to the Secretary of State and say that we need to look again at that 2018 statement, go back to that context and make the necessary decisions? People will not put up with just a broad range of recommendations —we need to get to the heart of the matter.

[Hannah Bardell]

The hon. Gentleman is absolutely correct. How many times must the families and the victims of Primodos have their hopes built up and then completely dashed? Is it not bad enough that they have gone through the trauma, the blame and having their children live with deformities and disabilities—as my hon. Friend the Member for Argyll and Bute (Brendan O’Hara) so precisely and devastatingly highlighted in the case of his constituent—without also having their hopes built up for a review that turns out to be a whitewash? That gives people no confidence at a time when, let’s be honest, confidence in politicians and the political process is not particularly good. We have an opportunity here to do something good, to do it well and to do it properly.

I have to say that my exchanges with the Medicines and Healthcare Products Regulatory Agency and with the expert working group have not been good. I wrote directly to the chair of the expert working group about people’s feelings and concerns, but the response that I received did not fill me with hope.

I am pleased that Baroness Cumberlege has taken on her new role of looking at hormone pregnancy tests, sodium valproate and medical mesh, but when she sought evidence, she did not include Scotland. I have now written to her, and that issue has been rectified, but it is important to remember all the devolved nations of the UK and ensure that they are appropriately included. We know what the academic studies have shown—the work of Carl Heneghan and Neil Vargesson has been exceptional—but there is now new evidence and we should ensure that it is included in any future plans or reviews.

What we need from the Minister is an acknowledgment of the power of the views across this Chamber and across both Houses, and of the serious impact of this issue on people’s lives. How many parents need to die without knowing what happened to their children because of a pill that they took? As the right hon. Member for Hemel Hempstead (Sir Mike Penning) said, these were women who believed that they were in the care of the NHS, that they were being given something that had been properly medically checked, and that they were not being put in danger. However, their health and the health of their unborn children were put in danger. Let us not forget that many women miscarried—there are many children who were not born because their mothers took this pill. This drug was used in Germany as an abortive and in another country as a pregnancy test. It does not take an expert to work out that that was absolutely wrong.

We have a choice, and we have an opportunity. There is a very powerful body of medical evidence that needs to be properly looked at. The Government also need to take a long, hard look in the mirror and think very carefully about why the expert working group failed so badly and why its terms of reference changed part of the way through. They need to make sure that that never happens again; that the victims of Primodos, including my constituent and all the constituents mentioned today, never have to go through any more pain and suffering; and that those victims will get truth, justice and answers to their questions. Do they need compensation? Yes, absolutely, but what they really want is an apology and an acknowledgment.

As the right hon. Member for Hemel Hempstead said, when something goes wrong, the right thing to do is put your hands up and say, “Do you know what? We got this wrong.” It is about time that that happened. I hope that now the Minister and her Government will finally do the right thing.

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[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.