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.
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?
On that point about evidence, so many medical records were destroyed. How is it possible to have an absolute evidential base for the reports, when the evidence seems to have been destroyed?
That is absolutely right; I thank my hon. Friend for that point.
I am pleased to see the right hon. Member for Maidenhead (Mrs May) in the Chamber. I know that, as Prime Minister at the time, she read this report. I note that in a recent Sky News interview she said
“I felt that it wasn’t the slam dunk answer that people said it was.”
I am truly grateful to her for commissioning Baroness Cumberlege to carry out a review that was both independent and credible.
Knowing what we now know, that the expert working group report was a whitewash, riddled with factual inaccuracies and conflicts of interest; knowing that studies from Oxford University have proven that the evidence in this report was deliberately manipulated to reach its conclusion; knowing that the Prime Minister of the day knew something was not right and then commissioned another review—how can it be right that any Government can continue to use this report to hide their sins?
Only a few weeks ago, lawyers used the report in court to defend their preposterous claims, and Ministers have used it as a basis to refuse and deny families redress. It is outrageous. I ask the Minister today: will she take a stand and do the right thing? Will she be courageous and read beyond the lines of the ministerial briefing she has been given? Only then will she agree with me that the expert working group report is not worth the paper it is written on.
The report stands in the way of justice for families affected by Primodos. I urge the Minister to work with us to set up an independent review of the scientific evidence, because I can assure her that only a truly independent review will find that there is an association between Primodos and malformation.
The scientific evidence is vast. Over several decades, numerous studies and animal experiments have found that the use of such tests can cause potential birth defects. In 2018, a team of academics at Oxford University conducted a systematic review of all previous human studies. They pooled together the data and found a “clear association” with several forms of malformation. At Aberdeen University, Professor Neil Vargesson has been working on this issue for years. He published research on zebrafish, which are genetically like humans, and found that the drug caused deformities in embryos. More recently, he has been working with human tissues and has again found the same association. There is another groundbreaking study take place in Sweden, which will be published soon. Again, that will continue to show how much evidence there is regarding this particular medication.
Does my hon. Friend share my concern that since the Cumberlege report there has not been progress on the vast majority of recommendations, and that for Primodos families time is running out? This issue needs to be addressed, and soon.
I thank my hon. Friend for that; I will come on to the recommendations of the Cumberlege review.
The Minister will know that in May this year, families took the issue to the High Court. It was a David and Goliath moment. Government and Bayer lawyers used the expert working group report to argue that there was no basis for a case. The families did not have sufficient legal representation, as the firm representing them on a pro bono basis pulled out without any real explanation. It was not a fair hearing and was never going to achieve a fair outcome.
The action to strike out thus succeeded. Had that not happened, the families would have been given their day in court—an opportunity to present new scientific evidence, to argue about the misconceptions of not using epidemiological evidence to prove causation and to scrutinise the heavily flawed expert working group.
When the Cumberlege review came out, the then Health Secretary, the right hon. Member for West Suffolk (Matt Hancock), went on the television and apologised, but nothing has happened since then. For the first time, the Cumberlege review, known as the “Independent Medicines and Medical Devices Safety Review” or IMMDS, looked at the historical evidence and the Government documents, which showed a cover-up, and concluded that Primodos had caused “avoidable harm” and it was preventable.
The UK regulator first received a warning about the drug in 1958. A definitive study was published in 1967, which linked birth defects to the synthetic hormones in Primodos. Baroness Cumberlege concluded that Primodos should have been removed from the market in 1967. The UK regulator failed in its duty of care to women: Primodos was eventually withdrawn in 1978, 20 years after the first warning.
Let me be clear by saying it one more time: an independent review found that Primodos caused preventable and avoidable harm—the Government cannot argue their way out of that—and recommended that the Primodos families should have redress. If the Minister wants to waste time by arguing that the Cumberlege review was not a scientific one, then we can have an independent review of all the scientific evidence, but let us not waste time; let us get on with it.
Order. This debate is well subscribed, so my advice to colleagues is to keep speeches to around seven minutes so that we can get the next debate in as well.
I thank the Backbench Business Committee for agreeing to the debate, and most of all I congratulate the hon. Member for Bolton South East (Yasmin Qureshi) on securing it. She has been an intrepid campaigner on this issue over many years, as have other Members, including my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning), who has another important debate later this afternoon on fibrodysplasia ossificans progressive. I am afraid I will not be able to attend, but I recognise the significance of that issue.
I will focus on three issues in the time available to me. I echo the sentiments of the hon. Member for Bolton South East: it is a pity that we have to be here yet again, making these arguments to Government. Up until recently, the Government have been able to say in debates that they could not do or say anything because a legal case was going through the courts. Well, that case is no longer in the courts, as a result of the decision taken by Lady Justice Yip, so the Government’s position today should be rather different. We will wait and see in the Minister’s response.
The other thing that the Government have done is hide behind the expert working group report, which the hon. Lady referred to. Many issues have been related to the expert working group report, which of course found in its overall conclusion that
“the available scientific evidence, taking all aspects into consideration, does not support a causal association between the use of HPTs, such as Primodos, during early pregnancy and adverse outcomes, either with regard to miscarriage, stillbirth or congenital anomalies”
Given that conclusion, it might seem rather strange to the Minister and the House that it was that very report that led to my setting up the Cumberlege review. The reason I did so was that earlier in the report it says:
I thank the right hon. Lady for the work that she did as Prime Minister to set up the Cumberlege review. May I take her back to her first point? She said rightly that the Government have been refusing to take forward the recommendations of the review because of the legal case, and that that case has now come to an end. Is she aware that the defendants in that case, including the Government, have sent letters to some of the applicants saying that they must sign away their right to take forward any further legal cases or be faced with, and pressured by, millions of pounds in legal costs? Does she agree that for the Government solicitor to be part of that process, and threatening those families, is quite atrocious?
I was not aware of that. I am very concerned by the situation that the right hon. Gentleman sets out, and I hope that the Government will urgently consider the position that their solicitors have been taking on that issue.
The second issue I will raise is the very important matter of redress. Let me refer first to the timeline. The report that everybody looks at as, in a sense, the first report of a potential causal link between Primodos and birth defects was, of course, the report led by Isabel Gal in 1967. There had been earlier indications of potential problems, and there have continued to be indications up until most recently. But it is not just that the NHS, through its various regulatory regimes, did not act on the basis of the 1967 report; later, even when Primodos was being withdrawn in other countries, it continued to be available to women here in the UK. As my right hon. Friend the Member for Hemel Hempstead rightly said in his intervention, we are not talking about some private clinics and doctors; we are talking about GPs in the national health service. It is that issue of responsibility that the Government need to address; that is important in relation to redress.
The Cumberlege committee said that the independent redress agency
“should be created based on models operating effectively in other countries.”
There are other countries where this issue has been recognised and redress is available. A redress scheme is being worked on for sodium valproate and for pelvic mesh. Why not for Primodos? I sincerely hope, now that the constraints of the legal case have been removed, that the Minister will be able to give a positive indication at the end of the debate that the Government will indeed consider redress for those who took Primodos and those who have suffered as a result.
My final point is one that was made to me recently by Marie Lyon. Women who took Primodos, and who saw their children suffer, often feel guilty; they feel somehow that it was them and their fault. It was not. They have no reason to feel guilty at all. The drug was given to them by their GPs. I hope that the Minister will stand up and say very clearly that women who took Primodos and whose children suffered were not in any way at fault and should not feel guilty at all. The fault lay with the NHS.
It is an honour to follow the right hon. Member for Maidenhead (Mrs May). I pay tribute to the work she has done and place on record my thanks to the all-party parliamentary group on hormone pregnancy tests, which is very ably led by my hon. Friend the Member for Bolton South East (Yasmin Qureshi), who secured the debate. She demonstrated her passionate support for those affected by this great injustice that it has taken far too long to put right.
I would also like to mention the Association for Children Damaged by Hormone Pregnancy Tests, led by the redoubtable Marie Lyon, whom we all know and have met, as well as our constituents who have been subject to the terrible effects of taking Primodos in their pregnancies. Both the APPG and the Association for Children Damaged by Hormone Pregnancy Tests have campaigned tirelessly—this year marks a decade of the APPG—for countless families who have had their lives irrevocably changed by the impact of Primodos.
Locally, my constituent Marjorie Lancaster-Smith has long been an active campaigner within these groups and has shared with me at length the impact that Primodos has had on her family. Following the use of Primodos during Marjorie’s pregnancy, her daughter Tania has complex heart and intestinal problems, which she has had to live with her entire life. These have impacted both Tania and the family as a whole, and she has had several periods of severe ill health, operations and complications that have been life-threatening on several occasions. Both Marjorie and Tania are missing vital medical records—in fact, there are none at all for the first few years of Tania’s life or for Marjorie’s pregnancy. It is therefore very difficult to have definitive proof of exactly what happened to them. This is a convenient omission—that is all I am going to say.
This campaign has been incredibly trying for many families, as they have often felt sidelined and stonewalled at every turn as they pursue justice for their now grown-up children. However, as this debate and those attending it today demonstrate, they remain determined to win their campaign for answers and redress. As Marjorie movingly put it in one of our recent communications,
1:35 pm
Suzanne Webb (Stourbridge) (Con)
I thank the hon. Members for Bolton South East (Yasmin Qureshi) and for Livingston (Hannah Bardell) and pay tribute to all the work they have done. I also thank Beccy’s family, who I am going to talk about today and who I met recently, and Beccy. Beccy’s family are sitting in the Gallery today.
This is Beccy and her mum Helen’s story. In 1970, when Helen thought she was pregnant, she went to her doctor in Wrexham, north Wales, to confirm the pregnancy. At the time, Helen, aged 24, was a mature student at a teacher training college. Her husband had just got a job in Stourbridge, and she was living with her parents while completing her college course and needed to be sure about the pregnancy as soon as possible. At the time, there was no reliable simple pregnancy test available. The GP said that there was a new product available, which would be the quickest way to confirm the pregnancy. He produced two pills from his desk, for which there was no prescription. The drug was Primodos. These were to be taken on consecutive days. If she was not pregnant, she would have a period within a few days. If she was pregnant, there would be no period. Helen’s medical record confirms that she took Primodos in March 1970.
By way of an explainer about Primodos, the same components that are in Primodos are contained in oral contraceptives, but at 40 times the strength of a contraceptive—40 times. That puts it in context. At the time, the doctor explained that the tablets came with a warning that they should not be used for pregnancy testing if the woman was not young and healthy. For example, they should not be used if the woman was older or suffering with conditions such as diabetes or heart problems. None of this applied to Helen—she was only 24—so he decided that this would be the best way to confirm whether she was pregnant.
Beccy was born on 7 November 1970. Her mum had a normal pregnancy and a normal birth. Beccy weighed in at 8 lb 4 oz and appeared a bonny, normal baby. At first, Beccy appeared to develop normally, though she did have many screaming sessions. As first-time parents, they did not think this unusual. Beccy seemed generally fit and healthy, though it seemed that she was not developing as other babies were. When she did not sit up, roll over or crawl at the expected times, her mum was told that she was just being a fussy young mother, but as Beccy got older, it became apparent that she was severely handicapped.
Beccy has never walked and has always been wheelchair dependent. She has curvature of the spine and some deformation of her hands and feet. She had an operation to try to straighten one of her feet when she was six. These problems are worsening as she gets older. Her mental impairments are very severe. She has had many diagnoses including cerebral palsy and autism, and this leads to very complex and challenging behaviours. She will often go days without food and refuse to co-operate with her carers. She has very limited speech, though it is believed she understands much more than she is capable of expressing. This can be very frustrating, and she is often reduced to very distressing screaming sessions. Beccy has been subjected to innumerable tests and procedures, including full genetic screening. There has been no explanation or cause for her impairments. Primodos is the only common denominator.
It is always a privilege to follow the hon. Member for Stourbridge (Suzanne Webb). I think the whole House is grateful to her for telling the story of her constituents and their daughter Beccy. It is so important that the Minister and colleagues hear the impact that Primodos has had on ordinary families, and why we need justice.
I have been involved in this campaign for nearly a decade, but there are three women who have been critical in leading it. The first is the hon. Member for Bolton South East (Yasmin Qureshi), who has chaired the APPG, but who has also done many more things: she has had more meetings, asked more questions and sent more letters, and we are all grateful to her. She is one of the greatest campaigners this House has seen in recent times. Like others, I also pay tribute to Marie Lyon and her husband, who have campaigned with more courage and bravery than I have seen from anyone outside this House in my time here. They are relentless, representing the interests of thousands of women and their families. They are not going to give up until they get that justice, and neither should we.
The third woman I want to mention is a lady called Sue Ilsley, the constituent who brought this issue to my attention. Sadly, Sue died earlier this year. I actually got to know her before this, because she was a campaigner on mental health issues in my constituency; as far as I was concerned, she was the best campaigner. I think that was partly because her mental health had been impacted by her experience of having taken Primodos as a teenager and then giving birth to a daughter—a wonderful daughter, but a daughter who had serious deformities as a result of Primodos. She campaigned on mental health, and later she brought the Primodos issue to me. When I used to speak to her, I could obviously feel her hurt and her anger, but just as the right hon. Member for Maidenhead (Mrs May) said, I could also feel her guilt. She should not have had any.
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I have no doubt that later in the debate the Minister will stand at the Dispatch Box and tell the House that there is nothing she can do for the Primodos families because there is no proven association, because she has been convinced by the civil servants, the Medicines and Healthcare products Regulatory Agency and others. Would she like me to send her some of these studies—or perhaps I can hand them to her today? Is she willing to confront the truth, or is she going to be like her predecessors, burying her head in the sand? As long as she takes that position, she is standing in the way of truth and justice.
The families have already been through so much in their lives. Many of them have died, others are still very unwell. Why do the Government still insist on putting them through so much emotional and mental anguish? I ask the Minister to look at the Public Gallery, where some of those families sit, having travelled from across the country. Their campaign has been led by the amazing Marie Lyon, and they have been on a long and challenging journey, spanning almost five decades, to achieve justice. Their stories are at the heart of that justice. Those in the Gallery are just some of the families, but there are many hundreds more.
Justice delayed is justice denied. The legal system has failed those families, and so far the Government have failed them as well. I ask the Government to include Primodos families in the redress scheme being delivered to the victims of mesh and valproate as a result of the recommendation in the IMMDS/Cumberlege review. This was once referred to as the worst medical fraud of the 20th century, and I believe that to be true. The families are entitled to seek reparation and redress, as the Cumberlege review made clear. The Minister has an opportunity. She has it in her power to dispense justice and grant the affected families the redress that they rightly deserve. The ball is in her court.
“The totality of the available evidence from pharmacology, non-clinical, epidemiological and adverse event reporting data was very limited and did not, on balance, support a causal association between the use of HPTs, such as Primodos, by the mother during early pregnancy and congenital anomalies in the child.”
To me, “on balance” means that there was an argument against a causal link and, on the other side, an argument for a causal link, so the strength of the absolute decision that the expert working group came out with was, I think, a misrepresentation of what they had put earlier in the report. It was that sense of a balanced argument that led me to call for the Cumberlege review.
“Nevertheless while there is breath in my body, I will continue to support my daughter and all our members who struggle every day because of the damage caused by Primodos. It is an absolute disgrace that they have not received justice and that Bayer”—
the pharmaceutical company that manufactured this drug—
“and the Government think they can just walk away scot-free.”
In the three years since Baroness Cumberlege’s independent medicines and medical devices safety review reported, we have seen long overdue work undertaken to support those impacted by pelvic mesh and sodium valproate, including the development of redress schemes, but Primodos victims have had no action whatsoever—indeed, there has been total silence and avoidance. I echo the point made by the right hon. Member for Maidenhead that as the legal process has now ended, what ended with it was the Government’s latest excuse for not pursuing some form of redress. I hope that the Minister is able to reassure us that that position has now changed.
As other Members have highlighted, the all-party parliamentary group has three clear asks of the Government, which I hope the Minister will address when she responds: first, that the sensible and necessary recommendations made in the independent medicines and medical devices safety review relating to Primodos be implemented, including the creation of a redress fund for the families affected; secondly, that there is an acknowledgment of and explanation for the present lack of implementation of those recommendations, because it has now been a long time—three years; and finally, the withdrawal of the highly disputed findings of the expert working group, which my hon. Friend the Member for Bolton South East talked about. The right hon. Member for Maidenhead has called those findings into question, and she explained in her contribution why she did that.
Families such as Marjorie’s are long overdue answers for this miscarriage of justice, and they are all desperate to ensure that no further families suffer the adverse consequences of medicines they take or medical devices they have been given by the NHS without having access to redress much more quickly. They have endured great suffering, and they will continue to experience that suffering as a product of the use of Primodos during pregnancy. That suffering cannot be diminished, and it is a tragedy that they have had to wait so long and been so neglected, and that they are now being stalled just when they thought that finally, after years of campaigning, their suffering and the adverse effects had been recognised. I call on the Government to build on the statements of previous Ministers and finally take action to implement the recommendations of the review in full—critically, including the consideration of a redress scheme specifically for Primodos-affected families.
Beccy lives in a residential home with 24-hour care. She can do virtually nothing without help. She does stay at home with her family regularly, which is very important to her and her family; when she is at home, she relies on her family for all her needs, but that is becoming more and more difficult with age. It is also very distressing for her mum, who is terrified about what will happen to Beccy when she is not around. I have nothing but admiration for Beccy’s family, and it was a no-brainer that I would want to speak in today’s debate, especially as I am not sure that anyone is giving the families a fair hearing.
The history of Primodos has been well described, so I just want to highlight the issues that are pressing for this family. The first is the report of the expert working group in 2017. The working procedures of the EWG and the conclusions of its report have been widely criticised, and the family are now seeking a properly independent review of them. They believe that such a review is necessary for acknowledgement and justice for their daughter. They want to be listened to, and I want them to be listened to. My right hon. Friend the Member for Maidenhead (Mrs May) and others have talked about the fact that these were not private clinics: it was the NHS that issued Primodos, so I think we are all looking for that redress.
I therefore want to raise with the Minister the necessity of a fully independent review of the expert working group report, so that all these families and individuals can be heard. After all, the first warning signs of harm were in 1958, when a Dr Edwards said that Primodos can cause damage to the foetus in the early stages of pregnancy. It is not something that has just come to light; it is something that has continually been raised as an issue. Many more warnings were forwarded to the Committee on Safety of Medicines, the UK regulator, from 1958 to 1967. All of those warnings were suppressed by the committee and Primodos remained on the market until 1978—20 years after the first warning was received by the UK regulator. These families want a fair hearing, and I believe they deserve one. I support the family 100% in their call for the UK regulator to stop protecting the drug companies and start protecting women and children.
So that is Beccy’s story. It tugs at the heartstrings. Not only has Beccy been robbed of a normal life; the effect on the family has been all-consuming. However, her story is not a one-off. The context to Beccy’s story is simple: her mum took Primodos at the age of 24 to establish whether she was pregnant, because she was advised to do so. Primodos contains the same components as oral contraceptives, as I mentioned, but at 40 times the strength. We do not have to be medical experts to work that one out.
There are guilty people. The right hon. Lady mentioned the NHS, but I want to take it back: Schering, the original drug company that has now been bought by Bayer, bears a lot of the guilt. All the professionals and the various medical regulators who have looked at this issue over the years bear the guilt. We should not finish campaigning until those guilty people are brought to justice. Experts and judges have looked at this recently and said, “They are not guilty”—well, they are. Look at the evidence. The expert working group was shocking, and when the right hon. Lady was Prime Minister, she was quite right not to accept its report and to go for the review. We had a debate in 2019 in which that report was pulled apart, and we have seen the work of Carl Heneghan, Neil Vargesson and others, who have proved as scientists and statistical experts that the evidence is overwhelming.
I am not a scientist or a medic, but I can sort of understand legal notes, and when I spoke in this House in December 2017, I read extensive extracts from the minutes of meetings held on 20 and 21 December 1977 at the Goldsmith Building, Temple, London. Schering, the original pharmaceutical company, was getting legal advice from a Mr Clothier QC. I will not repeat that speech today, but I will repeat a few of the things that I mentioned:
“Mr Clothier felt, if the case were tried to the end by a judge, the chances were that the company would be found to be in neglect of its duty.”
This was in 1977.
“Clothier stated that there seemed to be a 5:1 chance that, if there were a malformation in a child and the mother took Primodos while pregnant, it was the fault of the drug”,—[Official Report, 14 December 2017; Vol. 633, c. 707.]
so Schering knew that. That was its legal advice decades ago. Page 7 of the memo from the Berlin archives, which this note came from, states that Mr Clothier told Schering that
“there were 2 alternatives open to us—one is to establish a voluntary scheme of compensation in which a justifiable claim will be given compensation without proof of liability but simply accepting moral responsibility.”
The company’s review came to that conclusion. Decades later, why has it not happened?
The other alternative was to take the claims to court. What I found really interesting, and what I want to focus colleagues’ attention on, is that according to the memo, the Schering representative, Dr Detering, said that he was
“hesitant in establishing a scheme as the product is marketed world-wide. If we introduce this scheme in one country, we should introduce it in other countries.”
This product was marketed in 81 countries. That is the issue here; that is why there has been a cover-up for decades. That is why the medical regulators have stood behind the pharmaceutical company in question, because they know this would cost the company a fortune. Its shareholders would have to cough up—possibly cough up billions. In my view, this is potentially one of the biggest cover-ups of a pharmaceutical outrage that the world has ever seen.