Hormone Pregnancy Tests

Mike Penning Excerpts

Thursday 7th September 2023 Commons Chamber

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

I beg to move,

That this House notes that children were born with serious deformities due to the hormone pregnancy test drug Primodos, which was taken by expectant mothers between 1953 and 1975; further notes that official warnings were not issued about Primodos until eight years after the first reports indicated possible dangers; observes that the report by the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests in 2017 was inconsistent with other academic reports; notes that the Independent Medicines and Medical Devices Safety Review, First do no harm, found that Primodos caused avoidable harm; further notes that the Government has refused to acknowledge the recommendations by the Independent Medicines and Medical Devices Safety Review relating to Primodos families; and calls on the Government to fully implement the recommendations in the Independent Medicines and Medica al Devices Safety Review and to set up a redress fund for families affected by Primodos.

I thank the Backbench Business Committee for granting this debate. This is now the fifth time we have had a debate trying to persuade the Government to grant justice to families affected by Primodos. I cannot even begin to count the number of times in the last 12 years that this issue has been raised on the Floor of this House during Prime Minister’s questions, Health questions, business questions and even Treasury questions. Time and again, this Government have insisted that there is no credible evidence to support an association between Primodos and deformities. Indeed, they have gone to great lengths to try to prove that there is no association at all.

I remind this House that Primodos was a tablet given to patients by their general practitioner as a pregnancy test. It was 40 times—I repeat, 40 times—the strength of an oral contraceptive today. It does not take a scientist to imagine what a dosage of that strength would do to a foetus. Babies were born with severe deformities, babies who are now adults in their 40s and 50s and have lived their whole lives with these disabilities.

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

May I take the hon. Lady back a few moments to the tablets that were given by the patient’s GP in a national health surgery, paid for by the national health, and the doctor was paid by the national health? It was not private clinics, but the national health giving this drug.

[Yasmin Qureshi]

I thank the right hon. Gentleman for his intervention. It is important to stress that it was the state, the NHS, involved in this.

In July 2015, I stood in this House and urged the Government to disclose all the evidence they had and to set up an independent inquiry. The then Minister, the hon. Member for Mid Norfolk (George Freeman), heard those concerns and agreed to an independent review, which would be led by an expert working group.

However, first, the expert working group was not independent. In fact, many of the experts were found to have conflicts of interest with the industry. Secondly, the review of the evidence conveniently ignored several important studies and then later said, “Oh, well, there was insufficient evidence.” Thirdly, the terms of reference of the review had said that it would try to find a possible link. Yet the reports’ conclusion said it was unable to find a “causal link”. How exactly does the Government intend to find a causal link, short of testing the drug on pregnant women?

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[Ed Davey]

I am grateful to the hon. Lady for her intervention. I did not see that particular programme, but I am sure she is right. The key thing is that we need to make sure that those large organisations are held to account. That is our job, and we have been failing, because we have not held them to account—we are still here, many years and many debates later. We have had a Prime Minister on our side, and these people still have not been held to account.

[Sir Mike Penning]

Actually, the records show that this issue did get to court in America, and the drug company did a deal—as happens in American courts—on a non-disclosure. Why would a drug company do that unless it was trying to cover up? It settled in the American courts, as I understand it, but on the basis that all the information was destroyed and would never be disclosed. Those are the sorts of things we are dealing with.

[Ed Davey]

The right hon. Gentleman is right to remind me and the House of that particular case. Interestingly, an American law firm was helping the campaign and was going to take the issue to court because of what had happened in America. For some reason, it pulled out.

[Sir Mike Penning]

What a surprise!

[Ed Davey]

Yes, what a surprise. All these examples add up to show that a lot of powerful people are trying to stop justice being done in this country and around the world, so I am so pleased to see cross-party support here today, in a very powerful way, to make sure that is put right.

Justice should come before the interests of the shareholders and justice should come before the professional reputations of the medical people on the regulatory bodies, and that is why the Minister should listen to the House today. Absolutely we should see the recommendations of the review come forward and absolutely there should be the compensation fund. She should get up at the Dispatch Box today and announce that. The offer that was made, I am told—I have not seen it in writing, but I am told an offer was made—was a £1 million total pot for all the families, which would have been a few thousand pounds per family. I hope the Minister does not suggest that that will be good enough. We need a proper compensation fund, and we will not stop fighting until that the Government provide for that. I hope she will respond to the answer from the right hon. Member for Maidenhead to my intervention about why Government solicitors are threatening the families and telling them they have to sign agreements that they will not continue any legal action, which goes exactly to the point that the right hon. Member for Hemel Hempstead (Sir Mike Penning) made.

I want to see that action and I want the recommendations of the review to be implemented, but I want to put on the record that I am a bit suspicious. I think those involved are going to try to wriggle out of this in some way. They are going to make sure that no liability is mentioned, but they were liable. They knew it in the 1960s and they knew it in the 1970s: they are liable, and everyone who has been looking at this case knows it. I want the review to be implemented because the families need the money now. Individuals are dying, such as my constituent, and people are worried about their adult children and need their adult children to have the money now. I want the Government to go ahead and do that now. But I will tell the House what I really want: I want a public inquiry. I am fed up with these reviews. The review was great, but because this is such a scandal—a global pharmaceutical scandal—we want more. All this will come out only if the lawyers cannot threaten people and have non-disclosure agreements, so I want an inquiry in public—a public inquiry so that these people can be properly held to account once and for all.

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[Allan Dorans (Ayr, Carrick and Cumnock) (SNP)]

There is considerable evidence indicating that those women who took the drug Primodos—prescribed by their general practitioner—and who were pregnant at that time gave birth to babies with serious birth defects, including deformities and disabilities, missing limbs, cleft palates, brain damage and damage to internal organs. In some cases, those women miscarried or had stillbirths.

[Sir Mike Penning]

This is a really important point: Primodos was not prescribed; no prescription was written. No pharmacist could look at the patient and say, “Is this the right drug for that person?” It was a drawer opened, tablets taken out and pushed across. I know it is not intentional, but the word “prescription” is slightly misleading.

[Allan Dorans]

I thank the right hon. Member for his intervention; he is absolutely correct. The surviving victims are now mainly in their 40s and 50s. Many face a host of new medical problems and their bodies continue to suffer. Many have died prematurely.

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[Margaret Greenwood (Wirral West) (Lab)]

I congratulate my hon. Friend the Member for Bolton South East (Yasmin Qureshi) on securing this debate, and thank her for her outstanding work in leading this campaign in Parliament. I also pay tribute to all the families of children who were born with birth defects after their pregnant mothers took Primodos for the courage that they have shown. In particular, I pay tribute to Marie Lyon—who, I am pleased to see, is here with us today—for her tireless work.

Those affected should not have to fight for justice. I join colleagues in the debate in calling on the Government to acknowledge the fact that the recommendations in the Independent Medicines and Medical Devices Safety review relating to Primodos-affected families have not been implemented, and to explain why; to implement those recommendations and to set up a redress fund for families affected by Primodos; and to withdraw the 2017 expert working group report on hormone pregnancy tests, which has been disputed by academics and is inconsistent with other more independent studies.

In their fight for justice, the families have suffered setback after setback. The latest came a few months ago when claims for damages against Bayer Pharma, Schering Health Care Ltd, Aventis Pharma Ltd and the Government were struck out in the High Court, partly owing to lack of funding for legal representation. That was a bitterly disappointing blow.

The Government have a moral duty to set up the redress fund for those affected. As far back as the late 1950s, concerns were raised that hormone pregnancy tests, the most commonly used of which was Primodos, could cause abnormalities in a developing baby. Further studies in the UK and elsewhere from the late 1960s to the early 1970s suggested a link between the use of hormone pregnancy tests and a wide range of serious birth defects.

It took until 1975 for the Committee on Safety of Medicines to recommend that hormone pregnancy tests should no longer be used. The committee said that there was “little justification” for them, as alternatives were available. It then sent an alert letter to all doctors in the UK, advising them of a possible association between hormone pregnancy tests and an increased incidence of congenital abnormalities. The letter recommended that doctors “should not normally prescribe” those products as pregnancy tests.

However, it has been reported that Primodos sometimes continued to be used as a pregnancy test within the NHS until it was withdrawn from the market by the manufacturer, Schering Chemicals Ltd, in 1978. By that stage, the damage had been done. Legal proceedings by the affected families began, but were discontinued in the early 1980s. It was not until early 2014, and the discovery of documents from the 1960s that reportedly showed that studies suggested that hormone pregnancy tests caused miscarriages and congenital abnormalities, that a new campaign called for an independent public inquiry into them.

Criticisms of the 2017 independent expert working group report on hormone pregnancy tests included the fact that it did not examine regulatory issues and that a number of documents had not been included in the review. Additionally, the methodology and findings in the report have been disputed by academics and are inconsistent with other academic reviews, as today’s motion highlights. One of those reviews was by a group of researchers at the University of Oxford, led by Professor Carl Heneghan. The researchers concluded:

“The evidence of an association”—

by which they mean between hormone pregnancy tests and birth defects— “has previously been deemed weak, and previous litigation and reviews have been inconclusive. However, we believe that this systematic review shows an association of oral HPTs with congenital malformations.”

Despite that, the Government say that they currently have no plans to reassess the findings of the expert working group review. I hope that, today, we hear a different response from the Minister.

In 2018, the independent medicines and medical devices safety review was announced by the Government, led by Baroness Cumberlege. Despite the Cumberlege review’s finding that Primodos caused avoidable harm, and the clear recommendation for redress for those affected, the Government have refused to even acknowledge it. That is a grave injustice and an insult to those who have suffered. Let us remind ourselves of some of the adverse impacts that affected individuals and families have attributed to hormone pregnancy test use: congenital heart defects, dysmorphic facial features such as cleft palate and lip, digestive system and bowel issues, intellectual disability, limb defects and, tragically, death.

[Sir Mike Penning]

Could I add to that those who were told to have an abortion, and those who had a miscarriage or a stillbirth? Their families have been damaged almost as much, and the guilt is still with them.

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

It has been an honour and a privilege to sit through this debate. As usual, I will be speaking with no notes, because a lot of what has been said today I would have said myself. I pay tribute to the chair of the all-party parliamentary group, the hon. Member for Bolton South East (Yasmin Qureshi). We have done much work together over the years.

I pay tribute to Marie Lyon and all the other campaigners, but there is something about this debate. Every time we have it there is unity, conformity, passion and love in the Chamber but, as my right hon. Friend the Member for North East Somerset (Sir Jacob Rees-Mogg) said, it disappears into Government and does not come back out. Governments of all descriptions have known about this for years and could have done something about it, but, for some unknown reason, they did not. When I was a Home Office Minister under my right hon. Friend the Member for Maidenhead (Mrs May) we did other inquiries together, but we had to battle to get them.

I do not understand why Governments, of all descriptions, do not come to the House to make statements, so we have to UQ them. It is plainly obvious that we will get a statement. We had three statements today, and quite rightly, but the Government would have been UQ-ed if they had not come to the House. Perhaps common sense is prevailing.

When it comes to really serious issues, like Primodos, for some unknown reason the Government, the Department and the Treasury pull down the shutters. It is not one Department, and I fear for the Minister when she stands at the Dispatch Box, because this is way outside the remit of just the Department of Health and Social Care.

We heard earlier that Government lawyers are threatening activists who are trying to get justice for their families, loved ones and others. Many of these campaigners have lost their loved ones, and some of them were victims themselves when they were told to have an abortion or when they had a miscarriage or stillbirth. A lot has changed in society but, in the 1960s and 1970s, it was a really difficult thing for a woman to go to her GP because she thought she was pregnant, especially if she might be a single mum. These couples and single mums were passionately waiting for this pregnancy to make their life fulfilled, and then, a short time later, they were told that perhaps the best thing to do was to abort the child because they would have terrible deformities, or they might go through childbirth. I am lucky enough to have just become a grandfather. I remember being there 33 years ago when my wife punched me on the nose halfway through childbirth. She did not intend to do it; she had no idea what was happening. She was just in a lot of pain and doing that made her feel better. These women were there and then all of a sudden they realised that the disfigurements and abnormalities were there to be seen—or, as we have heard in this debate, not seen until a little later.

We will be having a debate later, which I will be leading, about a situation where babies are born exactly like that and people are being told, “Oh, they’ve got bunions.” They do not have bunions; they have a genetic deformity. But because that deformity is so rare, no one understands it. On this issue, however, the Government, the NHS, the GPs and the drug company knew what they were doing. If the drug company had withdrawn Primodos after a year, when it first started to see this, most of us would have understood that these sorts of situations occur and it should, rightly, have compensated. However, that is not what happened. This went on year after year, with it knowing about this drug.

My point about the word “prescribed” is not just semantics; this drug was not prescribed. A prescription is a prescription. Opening a drawer and giving out a couple of tablets to the lady in front of you is not a prescription; it is a handout. This was done with no information given as to the dangers that we all see today. We have only to buy a packet of paracetamol to see written across the back of it what could happen. These ladies were not given that opportunity. They needed to know whether or not they were pregnant, for whatever situation they were personally in, and the GP then opened the drawer. This was in an NHS surgery, with a GP who was self-employed, as they mostly are, but paid for by the NHS. Those drugs were given not through a pharmacist, but directly from the drug company to the GP to hand out.

Let me conclude on an area that we have not really touched on, and it is something that Governments need to understand. I was a shadow health Minister for four years and I was passionate about this. The damage to our NHS of public understanding of this is so, so bad. The public need to trust the NHS. When they go to their GP, they need to be able to trust that if something needs to be done, it will be done for them and not for the system. Our NHS is being damaged by the way this cover-up continues. Government lawyers have accepted bits of Baroness Cumberlege’s report, but the fundamentals of it, which my right hon. Friend the Member for Maidenhead made sure happened, have been completely ignored. We can run around the head of a pin and say, “It is because there was legal action here and legal action there,” but we should say, “Let’s just do what is right. We have made a mistake, in the Department or in the drug company, and we are going to put it right and put it right today, for those families who are still there and for those families we have lost.” That is the decent thing that this House should do.

[Mr Deputy Speaker (Mr Nigel Evans)]

We come to the wind-ups. I call Hannah Bardell.

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[Maria Caulfield]

I can show the hon. Lady my remarks—they are on the back of this paper, and I have been writing them down during this debate. I am only two minutes into my speech and I am addressing some of the points that were made. I will of course come on to Primodos as well.

It is important to recognise that we did take those issues in Baroness Cumberlege’s review seriously. We could not look at the issue around Primodos at that time because of the legal case, which I have touched on, but there have been some reviews. My hon. Friend the Member for Mid Norfolk (George Freeman) was here just before this debate. In his time as Minister for Life Sciences, he took the campaigns and the evidence around Primodos so seriously that he set up the expert review in 2014 to look at the evidence that was in place. I hear very loudly this afternoon some concerns about that expert working group and that maybe evidence was either misinterpreted or not looked at, but that expert working group did look at the evidence at that time and also issued a public call for evidence.

[Sir Mike Penning]

The so-called expert group changed the remit that it was given, with no recourse, as I understand it, to any Minister for permission to do so. It changed the terms of what it was supposed to look at, which is not what it was asked to do in the first place.

[Maria Caulfield]

I hear my right hon. Friend and, as I said, I will come on to that specifically towards the end of my remarks.

There were further evidence reviews. Hon. Members have touched on the evidence from Heneghan et al., and from Brown et al. in 2018. Those were looked at, and again there was no evidence of causality found in those reviews.