Hormone Pregnancy Tests

Theresa Villiers Excerpts

Thursday 7th September 2023 Commons Chamber

[Theresa Villiers (Chipping Barnet) (Con)]

I was moved and saddened to read of the lifelong health difficulties experienced by one of my constituents, whose mother was given the Primodos hormone pregnancy test. It is a story of school, work and family life disrupted over a period of decades, with frequent hospital visits, multiple operations, organ transplants, and a lifetime requirement to take a powerful concoction of immunosuppressants and other medication. I was hugely impressed and inspired to hear of this brave individual’s determination to succeed in life despite that adversity, and I believe it is time that he, and other Primodos victims, are finally given justice. I pay tribute to all the campaigners who have continued their fight for redress over all these years, despite so many setbacks.

The first warning of harm caused by hormone pregnancy tests came as early as 1958. Over the following period, many further problems were highlighted to the regulator of the time, the Committee on Safety of Medicines. As we have heard, the 1967 study by Dr Isabel Gal provided a clear warning of the serious damage being done by those tests, yet the sale of the product was not formally halted until 1978, 20 years after the first safety alerts, and 11 years after Dr Gal’s ground-breaking study. Since then, research has repeatedly indicated that taking the test increased the risk of children being born with debilitating and life-shortening birth defects such as damaged limbs, brain damage and heart problems.

A major review was conducted at the University of Oxford in 2018, led by the distinguished scientist Professor Carl Heneghan, director of the Centre for Evidence-Based Medicine. That study looked at 26 hormone pregnancy test studies involving over 76,000 women. The researchers concluded that taking drugs such as Primodos increased the risk of birth defects by 40%. They found “a clear association” between Primodos and several forms of malformation.

[Olivia Blake (Sheffield, Hallam) (Lab)]

I am a biomedical scientist by background, and having read that review, what I find important is the way the researchers interrogated all the subsequent research that had been done, to ensure that there was no bias in any of the studies they included, and they excluded any studies that they felt were biased, using stringent statistical analysis. That makes the review all the more important to listen to.

[Theresa Villiers]

I agree with the hon. Lady. It was a rigorous study, and it is a concern that in 2019 MHRA experts rejected that report, arguing that the quality of the studies examined was poor and the methods used to analyse them were

“not in line with best practice.”

As the hon. Lady pointed out, I do not think that is justified, and the Oxford team behind the research strongly refuted the claim made by the MHRA.

Despite all the scientific studies and research, campaigners have so far failed in their attempts to get compensation through the courts, and they have not been able to establish clear enough evidence of causation. That has been a massive hurdle in many cases over the years, not least in relation to tobacco, where it took decades of legal battles finally to show beyond doubt the causative link between smoking and cancer.

One of the problems faced by the families campaigning for compensation in this case is that many of the scientific studies of the ’70s and ’80s just do not meet the standards we necessarily expect in the 2020s. Many times in this House the call has come from Back Benchers loud and clear to support the families, to listen to their stories and to secure a fair outcome at last. The pressure that has come from this Chamber in so many debates helped to secure the welcome decision by the then Prime Minister, my right hon. Friend the Member for Maidenhead (Mrs May) to include Primodos in the independent medicines and medical devices safety review, led by Baroness Cumberlege.

Baroness Cumberlege concluded that Primodos was responsible for avoidable harm, that it continued to be used for years longer than it should have been, and that a fund should be set up to support families with the cost of care. She was very clear that, in the face of growing concerns, it should have been withdrawn from 1967. Her report acknowledges the disagreement between experts on whether Primodos caused birth defects, but she stated

“the fact remains that thousands of women and unborn children were exposed to a risk that was acknowledged at the time. That should not have happened. This is not a case of us judging the actions of the past by the standards of today. This was discussed at the time, but not acted upon. The system failed.”

Those conclusions from Baroness Cumberlege are truly damning. We have a Government-sponsored independent review concluding that the system failed the victims and survivors of the Primodos tragedy. We must find a way to put that right and ensure that the families get the recognition and financial redress they deserve. I urge Ministers to listen to the House today and take action at last. We cannot let this injustice continue.

--- Later in debate ---

[Andrew Gwynne (Denton and Reddish) (Lab)]

I thank the Backbench Business Committee for granting this important debate and, as others have done, pay tribute to my hon. Friend the Member for Bolton South East (Yasmin Qureshi) for her tireless work on this issue. She not only secured today’s debate, but has been a powerful voice in this campaign for many years. I also wish to put on record my thanks to Marie and all the other campaigners.

The right hon. Member for Tatton (Esther McVey), who is no longer in her place, rightly said that debates such as this show Parliament at its best. I commend the contributions from my hon. Friends the Members for Wallasey (Dame Angela Eagle), for Manchester, Withington (Jeff Smith), and for Wirral West (Margaret Greenwood). I also commend the speeches and contributions from the right hon. Member for Maidenhead (Mrs May), who did some good work in this area as Prime Minister and carries on campaigning for justice, the hon. Member for Stourbridge (Suzanne Webb), the right hon. Members for Kingston and Surbiton (Ed Davey), for Tatton, and for Chipping Barnet (Theresa Villiers), the hon. Member for Ayr, Carrick and Cumnock (Allan Dorans), who is also not in his place, the hon. Member for North Devon (Selaine Saxby), the right hon. Member for North East Somerset (Sir Jacob Rees-Mogg), the hon. Members for Strangford (Jim Shannon), for Leigh (James Grundy), for Wolverhampton North East (Jane Stevenson), for Southend West (Anna Firth), the right hon. Member for Hemel Hempstead (Sir Mike Penning) and, last but not least, the hon. Member for Livingston (Hannah Bardell), who leads for the SNP. Parliament has spoken with one voice and Parliament has spoken incredibly strongly. We know, as we have heard today, that it has taken decades for those affected by the hormone-based pregnancy test Primodos to be heard let alone be given justice.

Around 1.5 million women in Britain took Primodos in the ’50s, ’60s and ’70s before it was finally withdrawn in the late 1970s. Since then, countless women have come forward to tell their stories, alleging impacts on their children ranging from congenital malformations, birth defects to miscarriage and stillbirth. The voices of these women and their families were not heard for decades.

The Cumberlege report, published in 2020 after being commissioned by the then Prime Minister, the right hon. Member for Maidenhead, and the Secretary of State for Health, was a watershed moment in this decades-long struggle. It investigated not only Primodos and other hormone pregnancy tests, but sodium valproate and pelvic mesh.

What the Cumberlege report found was damning. It concluded that Primodos caused “avoidable harm” and that the handling of this issue spoke to an institutional failure to take the voices of women seriously. The report made several recommendations relating to Primodos, including but not limited to: a full apology to those affected by Primodos, a patient safety commissioner, a redress agency for those harmed and a taskforce to implement these wide-ranging recommendations.

It is important to welcome the apology that the then Secretary of State for Health and Social Care made in 2020 following the publication of the Cumberlege review. But, as has been made clear today, this apology was supposed to be the beginning. I am concerned that the Government have so far fully completed only two of the nine recommendations in the Cumberlege review. Four are classed as ongoing and three have been outright rejected.

That glacial progress is just not acceptable, so I will press the Minister on some key points that stood out to me in the Government’s implementation update report of last December, and other developments since. First, in relation to the recommendation for specialist centres for those adversely affected by medications taken during pregnancy, the Department of Health and Social Care has reiterated its view that specialist centres are

“not the most effective way forward.”

Instead, the Government point to NHS England committing to improve care pathways for the children and families affected. The Government’s report states:

“The Teratogen Clinical Development Group has recommended a proposal for regional multidisciplinary and interdisciplinary ‘hub and spoke’ services to sit within specialised neurodisability teams”.

Those services would support the treatment of children and young people exposed to harmful substances such as Primodos. However, the update report simply states that NHSE

“will explore this recommendation further”.

Can the Minister update the House on where that work has got to?

Secondly, as has been highlighted today, there are concerns about the Government’s approach to this issue. There has been a refusal to discuss the redress scheme, in contradiction to the Cumberlege review. There have been reports of refusals to meet with campaigners and parliamentarians, and news of lawyers representing the Government backing efforts to strike out legal action. The list goes on and is becoming more and more concerning. Given the High Court ruling in May, which I know many campaigners were exceptionally disappointed by, what steps are the Government taking to better engage with parliamentarians and campaigners on this issue, and do they have any plans to reconsider their position on redress and implementation?

[Theresa Villiers]

I am really interested to know what Labour would do if it won the next general election. Would it set up a fund for financial redress?

[Andrew Gwynne]

There seems to be a bit of a trend for the current Government, and Ministers supporting the current Government, to be looking to Labour to fix some of these problems. We will look very seriously at these issues and the situation that we inherit after the next general election, but I want today’s Minister and her Government to do what they need to do now, not wait until the next general election, which could be 12 months or more away. We need justice and redress now.

This is not a party political issue; it is an issue for each and every one of us in this House—those who have contributed to today’s debate, and the many Members who have not. On both sides of the House, we have to ensure that this historic scandal is comprehensively addressed, and the sooner the better for the victims and families. I sincerely hope that in her response the Minister will agree with all that has been said today, and that we can secure some very long overdue justice for these women and their families.