Hormone Pregnancy Tests

Yasmin Qureshi 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?

[Peter Dowd (Bootle) (Lab)]

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?

[Yasmin Qureshi]

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.

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.

[Lilian Greenwood (Nottingham South) (Lab)]

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.

[Yasmin Qureshi]

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.

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.

[Several hon. Members rose—]

--- Later in debate ---

[Yasmin Qureshi]

First, I thank all Members who have spoken in the debate. In particular, I pay tribute to the vice-chair of the APPG on hormone pregnancy tests, the hon. Member for Livingston (Hannah Bardell).

The many interventions on the Minister from my colleagues show that we are very unhappy about what she proposes and what the Government seem to want to do about this. We want to meet the Minister, but not in six months or three months; we would like to have a meeting in the next week or so.

[Maria Caulfield]

Will the hon. Lady give way?

[Yasmin Qureshi]

We want to sit down with the Minister, and we want her to say to us, “This is what we are going to do about the Primodos case.” We do not want the Minister to tell us the problems. We want a system of redress right now—that is what we want from the Minister—and I hope that when we have that meeting, she and her officials will present to us the practical action they are going to take so that all the people who have been suffering for decades and decades actually get justice. We want her to tell us not about what has happened before or about the court cases, but about the actions she will take based on what the Cumberlege review said. [Interruption.] The Minister is muttering, but in the past it has sometimes taken us months and months to get a meeting with Ministers. I am glad that she has reassured us, and I hope that we will get a meeting in the next couple of weeks and that her and her officials will present a concrete plan for how to get redress for the victims. [Interruption.]

[Mr Deputy Speaker (Sir Roger Gale)]

Order. I know that, strictly speaking, the hon. Lady has only two minutes, but these are important issues. If she wishes to give way to the Minister, she may.

[Yasmin Qureshi]

I am sorry; I did not realise the Minister was asking to intervene. I give way.

[Maria Caulfield]

I just wanted to reiterate that I have pledged to meet the APPG and all its members. I have also pledged to look at the recommendations specifically in relation to Primodos. I think it is important to meet the families and the APPG, so that we can make progress on this issue.

[Yasmin Qureshi]

I thank the Minister for that intervention. I look forward to meeting her and her officials, and to a great scheme that will help the victims of Primodos. I remind her that if we do not get our meeting, or if we do not get a satisfactory result, we will be back again—all of us. We have been fighting for the past 10 or 12 years, and we will continue to fight this campaign, because the whole House is united behind it. I hope we will get positive news at our next meeting.

Question put and agreed to.

Resolved,

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.