Primodos 2024: The Quest for Justice Continues

Sharon Hartles is a member of the Harm and Evidence Research Collaborative at the Open University. Additionally, she is affiliated with the Risky Hormones research project, an international collaboration in partnership with patient groups.

Image courtesy: The Association for Children Damaged by Hormone Pregnancy Tests (ADCHPT).

In the aftermath of the extensive legal battle involving over 100 claimants affected by Hormone Pregnancy Tests (HPTs) and defendants including Bayer Pharma AG, Schering Healthcare Limited, Aventis Pharma Limited, and the Secretary of State for Health and Social Care, the reverberations persist. 

Since Mrs Justice Yip’s judgement on 26th May 2023, denouncing the proceedings as an ‘abuse of process‘, our attention shifted towards examining the ongoing consequences of the Primodos scandal.

As the forthcoming Annual General Meeting of the Association for Children Damaged by Hormone Pregnancy Tests (ADCHPT) is due to take place in Birmingham on 22nd June 2024,  recent developments are scrutinised against the backdrop of legal discourse.

A mere three months following the collapse of the high court battle, Sky News reported that claimants faced potential liability for costs exceeding £10 million. Lawyers representing the government’s Department of Health and pharmaceutical giant Bayer delivered a stark ultimatum: agree to forego any future legal action or risk shouldering substantial bills. This ultimatum, labelled as ‘bullying and intimidation’ by Marie Lyon, Chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT), left Primodos-affected families facing an agonising choice: surrender their right to seek justice or face financial ruin.

While Minister for Women’s Health Maria Caulfield’s offer to meet with affected families may suggest a willingness to address their concerns, the harsh reality remains unchanged. Despite Maria Caulfield’s reluctance to witness individuals deprived of justice due to financial constraints, systemic barriers within the legal system persist, perpetuating inequality.

The defendants—Bayer Pharma AG, Schering Healthcare Limited, Aventis Pharma Limited, and the Secretary of State for Health and Social Care—enjoyed privileged access to the legal system due to their vast financial resources, whereas Primodos-affected families encountered daunting financial obstacles.

The demand by the government’s Department of Health and Bayer to quash future legal claims underscores a troubling prioritisation of legal closure over factual scrutiny. This demand requires claimants to forego any future legal action, disregarding contestations (inconsistencies, alterations, contradictions, discrepant findings, and omissions) within the available scientific data at the time (as evidenced by the IMMDS Review Oral Hearing, Sky News Interview, and MP letter), regardless of potential future evidence. This highlights a disturbing trend where the interests of powerful elites eclipse the pursuit of truth and justice.

Let us not overlook that the Expert Working Group (EWG) chose to exclude the summary estimate from its report, notwithstanding twelve out of fifteen estimates indicating an association between Primodos and malformations (as evidenced below).

Image courtesy: All-Party Parliamentary Group Hormone Pregnancy A Bitter Pill: Primodos, The Forgotten Thalidomide report – published 27^th February 2024, p.20.

Let us not ignore the alterations made to the draft by individuals not affiliated with the Expert Working Group and Commission on Human Medicines (CHM), which raise legitimate concerns about external interference.

Let us also remember that the Expert Working Group’s report played a pivotal role in the court case involving over 100 Primodos-affected claimants, which was dismissed because the judgment determined that the position on causation had not “materially changed in the claimants’ favour” since the previous litigation in 1982.

What led to the exclusion of the summary estimate in the meta-analysis from the Expert Working Group (EWG) report? Who stands to benefit the most from removing evidence suggesting an association between Primodos and malformations from the published report?

The Primodos injustice once again took centre stage when Sky News reported in December 2023 new scientific evidence spearheaded by Professor Bengt Danielsson. This evidence concluded that Hormone Pregnancy Tests could cause a range of congenital problems, such as malformations and defects, and initiate a failed abortion process. Faced with renewed scrutiny, Women’s Health Minister Maria Caulfield committed to examining the new evidence. 

On 7th February 2024, the Patient Safety Commissioner, Dr Henrietta Hughes, unveiled The Hughes Report, a comprehensive strategy for addressing harms from medicines and medical devices. Despite identifying a ‘clear case for redress’ for the thousands affected by ‘avoidable harm’, Primodos was notably absent from this review. 

Image courtesy: Patient Safety Commissioner – Listening to patients The Hughes Report Options for redress for those harmed by valproate and pelvic mesh – published 7thFebruary 2024

The report explicitly stated that ‘Our terms of reference did not include the issue of hormone pregnancy tests’, a decision attributed to the Department of Health and Social Care (DHSC). In late 2022, Minister for Women’s Health Maria Caulfield, while defining the project’s terms of reference, omitted Primodos from the focus of redress, citing legal litigation as the reason. However, the case for redress for Primodos had already been established in the First Do No Harm Report. The Hughes Report aimed to explore how to provide redress options, making the exclusion of Primodos objectionable.

Marie Lyon, who attended the launch, later expressed her disappointment, stating in The Guardian, ‘I feel betrayed by the patient safety commissioner, by the IMMDS [Independent Medicines and Medical Devices Safety] review, and by the Secretary of State for Health – all three have betrayed our families because, basically, they have just forgotten us.’

Marie Lyon speaking at the Patient Safety meeting in Parliament on 7th February 2024.  Photo courtesy: Marie Lyon, ACDHPT Chairwoman.

Considering the renewed interest in Primodos sparked by the emergence of new evidence and the Minister’s commitment to investigate, Professor Heneghan has remained dedicated to raising awareness about the issue. His most recent contribution, ‘The Primodos Scandal – Part 6‘ published on 27th February 2024, builds upon the series initiated with parts 1 to 5 (Part 1, Part 2, Part 3, Part 4 and Part 5) released throughout June 2023.

These instalments presented compelling evidence and challenged the findings of the Expert Working Group Report. He emphasises the necessity for legal scrutiny of Primodos, a position Professor Heneghan continues to champion even in the face of the setbacks encountered in the court cases. 

Building on this momentum, on 29th February 2024, Yasmin Qureshi, MP, officially launched the report titled  “A Bitter Pill: Primodos, The Forgotten Thalidomide,” as part of the work of the All-Party Parliamentary Group (APPG) on Hormone Pregnancy Tests. The APPG on Hormone Pregnancy Tests, comprising over 133 MPs and Peers, stands as one of the largest cross-party groups in Parliament.

Photo courtesy: All-Party Parliamentary Group Hormone Pregnancy A Bitter Pill: Primodos, The Forgotten Thalidomide report – published 27th February 2024

It represents the collective interests of numerous constituents affected by the drug Primodos. Established in 2012 and led by Yasmin Qureshi MP, the group’s primary objective is to raise awareness of the challenges faced by families impacted by Primodos. 

APPG report on Primodos Scandal unveiling at Westminster on 7th February 2024.

Photo courtesy: Marie Lyon, ACDHPT Chairwoman.

The launch event at Westminster introduces the APPG’s report, which provides the evidence that the Government chooses to ignore, delves into the human toll of Primodos, and emphasises regulatory inadequacies, examining the Expert Working Group and The Independent Medicines and Medical Devices Safety (IMMDS) Review.

Led by Chair Yasmin Qureshi MP and Vice Chairs Hannah Bardell MP, Sir Ed Davey MP, and Sir Jacob Rees-Mogg MP, the cross-party group recommends implementing measures to address what it terms ‘one of the most significant medical frauds of the 20th century’ urging the Secretary of State to act accordingly.

Image courtesy: All-Party Parliamentary Group Hormone Pregnancy A Bitter Pill: Primodos, The Forgotten Thalidomide report – published 27th February 2024 – Page 33

During a parliamentary debate on 18th April 2024, Yasmin Qureshi pressed Maria Caulfield on whether she would commit to commissioning an independent review of the Commission on Human Medicines’ Expert Working Group’s report on Hormone Pregnancy Tests.

In response, Maria Caulfield merely expressed ‘sympathy’ for families who ‘believe’ they have suffered due to using Hormone Pregnancy Tests, stating definitively that there are no plans to initiate an independent review of the Expert Working Group’s findings.

At best, her response demonstrates a lack of proactive action to address the concerns raised. At worst, it reflects a dismissive attitude towards legitimate calls for an impartial review, potentially exacerbating distrust in the government’s commitment to transparency and accountability.

Notwithstanding the government’s steadfast stance, media coverage continues to shed light on the plight of Primodos-affected families. On 7th May 2024, Bristol Live published an article featuring Tracy Whiting, 53, from St George, who believes her lifelong health issues stem from the hormone pregnancy test pills her mother took while pregnant with her.

Tracy Whiting’s experiences, alongside countless others, serve as poignant reminders highlighting the human toll of this medical injustice, and the devastating impact of Primodos, amplifying the urgency for accountability. Despite persistent challenges and resistance, the voices of families impacted by Primodos and their advocates resound, calling for acknowledgement and justice.

In anticipation of the impending backbench business debate scheduled for 6th June 2024, where the All-Party Parliamentary Group (APPG) for children damaged by oral hormone pregnancy tests will convene in the Main Chamber of the House of Commons, Marie Lyon, Chairwoman (ACDHPT), has mobilised efforts to rally support from individual members of the group.

Marie has actively reached out to all 113 MPs who are part of the APPG, urging their attendance at the debate to represent their constituents’ interests. This discussion, specifically focused on addressing the issues surrounding Hormone Pregnancy Tests (HPTs) with a particular emphasis on the Primodos scandal, serves as a crucial platform for raising awareness, addressing systemic failures, and demanding accountability for the injustices endured by these families.

Marie Lyon’s call to action underscores the urgency to ensure that the voices of those affected by Primodos are heard and that their quest for justice is supported at the highest levels of governance. It is crucial that everyone who believes in truth and justice watches the debate and shares what they see and hear on all social media platforms. This engagement is vital in amplifying the voices of those impacted by Primodos and in advocating for meaningful change and accountability within the healthcare system.

Marie Lyon kindly provided the following statement reflecting on the urgent need to ensure that the voices of those affected by Primodos are heard and supported.

Approaching the Annual General Meeting of the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT) in Birmingham on 22nd June 2024, the imperative for action intensifies. Against the backdrop of resilience and advocacy, steadfastness is required. Each moment necessitates renewed commitment; every voice raised in solidarity strengthens the movement.

While the road ahead may be challenging, the dedication of affected families to truth and justice remains unwavering. Continuing to shine a light on the Primodos scandal ensures that the echoes of injustice are met with the resounding call for accountability, redress, and reform.

To learn more about the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT) campaign and keep up to date with news, visit primodos.org. 

 In addition, there are several ways you can support the campaign: 

• Follow ACDHPT on Twitter 
• Follow ACDHPT on Facebook 
• Encourage your MP to join the APPG for hormone pregnancy tests. 
• Donate to ACDHPT campaign 
• Contact Marie Lyon 

If you are interested in reading more about this injustice, Sharon Hartles has published several articles on the Harm and Evidence Research Collaborative blog that may be of interest: 

Primodos 2023: Fighting Against the Odds – A Denied Opportunity for Justice 

Primodos 2023: The Fight for Justice Continues for the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT) 

Primodos: Financial redress is long overdue 

Primodos, Mesh and Sodium Valproate: Recommendations and the UK Government’s response 

Primodos: The Next Steps towards Justice 

Primodos: The first step towards Justice

This blog was originally published by the Harm and Evidence Research Collaborative at The Open University.

See  https://www5.open.ac.uk/research-centres/herc/blog/primodos-2024-quest-justice-continues

Primodos 2023: The Fight for Justice Continues for the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT)

Sharon Hartles, affiliate of Risky Hormones, an internationally collaborative research project in partnership with patient groups, and member of the Harm and Evidence Research Collaborative, The Open University

Human embryo at 5 weeks.

A five-day hearing is scheduled to take place at the Royal Courts of Justice from May 2nd to May 9th, 2023, which marks a significant milestone in the civil litigation case related to Primodos. This demonstrates the unwavering determination of the affected families to pursue justice despite facing adversity. Nevertheless, the Department of Health and Social Care (British government) and German pharmaceutical company Bayer have filed applications to strike out the court proceedings. They contend that the plaintiffs’ statement of case discloses no reasonable grounds for bringing or defending the claim regarding Primodos, a hormone pregnancy test alleged to have caused harm.

Lord Markham, the Parliamentary Under Secretary of State at the Department of Health and Social Care, has confirmed that the department has applied to strike out a claim made by a group of individuals who allege that hormone pregnancy tests caused them harm. This decision was influenced by the findings of the Expert Working Group’s report on hormone pregnancy tests, which was published by the UK’s Commission on Human Medicines in November 2017.

Bayer, a multinational pharmaceutical and biotechnology company, has claimed that no new scientific evidence has emerged to contradict their prior assessment of the safety of Primodos, a drug manufactured by Schering which they acquired in 2006. According to a company spokesperson, this lack of new scientific knowledge means there are no reasonable grounds for litigation or a need to defend against a claim.

It appears that both Bayer and the Department of Health and Social Care are relying on a report by the Expert Working Group set up by the Medicines and Healthcare Products Regulatory Agency to support their strike out applications. This report in question, issued in November 2017, concluded that there was no scientific evidence to support a causal link between the use of hormonal pregnancy tests like Primodos and adverse outcomes such as miscarriage, stillbirth, or congenital anomalies.

It is important to note, however, that this report has been subject to criticism and controversy. This is because it was explicitly not within the remit of the Expert Working Group to make official recommendations or conclusions. Several have argued that the Expert Working Group did not consider all of the available evidence and that the report’s conclusions were influenced by industry interests. Some members of parliament have even labelled the findings as a “whitewash.” Others have pointed out that the report’s scope was limited and did not fully address the concerns of those who believe that Primodos and similar drugs may have caused harm.

The Expert Working Group was referred to as an “Independent” group in a press release by the UK’s Commission on Human Medicines, even though it was established by the Medicines and Healthcare Products Regulatory Agency, which is sponsored by the Department of Health and Social Care. This is significant because the department has a history of allowing Primodos to be sold on the British market, despite concerns about its safety. This clear potential for conflicts of interest raises serious questions about whether the Expert Working Group has the agency to conduct an objective and impartial investigation independently from government influence.

Back in 1982, the legal team representing the families discontinued their legal action, believing that it was unlikely to prove that Primodos was responsible for the alleged congenital abnormalities. After the discontinuation, the case was left open, and the judge made it clear that the plaintiffs were free to pursue the case again if new evidence linking Primodos to birth defects emerged, which is what they claim has happened. Therefore, the British government and Bayer’s attempts to strike out the case should be rejected because of the emergence of new scientific evidence.

On July 8th, 2020, the Independent Medicines and Medical Devices Safety Review published its report First Do No Harm. The independent review spanned a period of two years and involved an extensive analysis of evidence, encompassing written material, oral hearings and personal testimonies, among other sources, to draw its conclusions and formulate recommendations. The review made nine recommendations and proposed 50 actions for improvement, including the establishment of a Redress Agency and Schemes to cover the cost of care.

In a press release, Baroness Julia Cumberlege, the chair of the Independent Medicines and Medical Devices Safety Review, acknowledged that the healthcare system had failed to fulfil its first duty of ‘doing no harm’ to patients. The report emphasised the need for changes in the healthcare system to ensure that patients receive the best possible care and that the system is held accountable for any harm caused to patients. This admission of failure, along with the proposed recommendations and actions, was a departure from the previous report by the Expert Working Group.

During the Oral Hearing Sessions of the Independent Medicines and Medical Devices Safety Review on November 27th, 2018, Professor Carl Heneghan brought several issues to the committee’s attention regarding the Working Group Report’s findings. Professor Heneghan is the Professor of Evidence-Based Medicine in the Department of Primary Care Health Sciences at the University of Oxford.

He identified several concerning omissions and errors in the report. One of them was that the report combined two completely different treatments, namely oral contraceptives and hormone pregnancy tests. Additionally, the report was not constructed using systematic review methods and did not use standard methods for appraising quality. Sensitivity analysis was also not carried out. Finally, the report’s draft version contained a meta-analysis that provided a pooled relative risk in the forest plots, which was omitted from the final report.

Professor Heneghan is a seasoned researcher with over a hundred systematic reviews under his belt. He conducted a systematic review and meta-analysis on Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis. This study has undergone peer review and is indexed on PubMed.

According to Professor Heneghan, the evidence indicates an association between hormone pregnancy tests and “congenital malformations, congenital heart disease, musculoskeletal, neurological and a syndrome vacterl“. He submitted a report to the Independent Medicines and Medical Devices Safety Review, where he presented his findings and concluded:

Extract from Professor Heneghan’s report on Hormone Pregnancy Tests, submitted to the Independent Medicines and Medical Devices Safety Review  in December 2018.

At the Oral Hearing Sessions of the Independent Medicines and Medical Devices Safety Review on November 27th, 2018, Professor Neil Vargesson, a developmental biologist from the University of Aberdeen, presented evidence from a preliminary study involving the injection of human synthetic hormones into zebrafish embryos. The study showed varying results, with high doses of the drug  causing defects in the head, brain, nervous system, blood vessels, ears, eyes, and spine, and lower doses causing more subtle damage such as smaller eyes and heart problems.

Zebrafish embryos were chosen for the study due to their genetic similarity to humans, sharing 70% of the human genome, with 87.5% of the common genes seen in human birth defects. The study The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafish embryos, was published in February 2018. It specifically examined the effects of the synthetic hormones found in Primodos, Norethisterone acetate and Ethinyl estradiol, and found that these components caused developmental abnormalities in the embryos. The results of the study concluded:

Extract from a study published in February 2018, The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafish embryos.

Over several decades, numerous epidemiological studies and animal experiments have been conducted to investigate the teratogenic effects of Hormone Pregnancy Tests, including Primodos. These studies suggest that the use of such tests can potentially cause birth defects, such as neural tube closure defects, cleft lip and palate, limb defects, and cardiovascular defects in humans, as well as brain malformations, genital malformations in fetuses, embryonic death, and abortion in animal experiments. However, it is important to take into account the historical context of some of these studies and the limitations of the technology and methods used at the time of their execution. Despite these limitations, the studies listed below offer possible connections between Hormone Pregnancy Tests, particularly Primodos, and birth defects and other health issues.

2010s: Heneghan. et al. (2018),  Brown. et al. (2018), Tummler. et al. (2014)

2000s: Maier. et al. (2001)

1980s: Kricker. et al. (1989), Hendrickx. et al. (1987), Joshi. et al. (1983)

1970s: Rothman. et al. (1979), Nora. et al. (1978), Janerich. et al. (1977),

Gal. (1976), Greenberg. et al. (1975), Janerich. et al. (1974),

David., & O’Callaghan. (1974), Oakley. et al. (1974), Gal. (1972),

Gidley. et al. (1970)

1960s: Gal. et al. (1967), Johnstone. et al. (1964)

The British government’s attempt to strike out the litigation filed by the families affected by Primodos is further compounded by their use of public funds – which come from taxpayers – to defend their actions in the legal dispute. The use of public funds to defend their failures is highly unjust, especially considering the role of the government in overseeing healthcare and ensuring patient safety. This raises concerns about the fairness of the legal process, particularly given the obstacles that ordinary families face when pursuing legal action against powerful organisations like the Department of Health and Social Care (which is part of the British government) and Bayer (one of the largest corporations in the world).

In a stark contrast to the government’s approach, families impacted by Primodos use have opted for a more grassroots effort to pursue justice. They have taken matters into their own hands and launched crowdfunding campaigns, with the support of the British actor and political activist Ricky Tomlinson, to raise funds and strengthen their legal representation. Two of the current campaigns include:

• Crowd Funder – Official 22/23 Autographed Liverpool FC Shirt.

The winner of this campaign was announced live on Facebook by Ricky Tomlinson on Sunday, April 2nd, 2023 at 7pm.

• Crowd Funder – A Collette Collinge Limited Edition Framed.

The winner of this campaign was announced live on Facebook by Ricky Tomlinson on Wednesday, March 1st, 2023 at 7pm.

The Primodos-affected families have been on a long and challenging journey to achieve justice spanning almost five decades. Sadly, the passage of time has also resulted in the tragic loss of many members who fought tirelessly for accountability and redress. Marie Lyon, Chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests, stated, “In 2014, new scientific evidence was presented to the British government. Since this time, a further 36 of our members have died waiting for the government to acknowledge responsibility.”

Image information shared by Marie Lyon, Chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT), with the consent of the families of the deceased members.

It is imperative that the legal system acknowledges and confronts the damage inflicted upon the families affected by the use of Primodos. This case cannot be disregarded, and those responsible for manufacturing and distributing the medication must be held responsible. The families have endured prolonged agony and hardship, and they are entitled to a just opportunity to seek reparations and legal redress. The justice system must ensure that the families impacted by Primodos have access to a clear and unbiased legal system that considers the harm they have suffered, and the necessity for accountability. The time has arrived to dispense justice and grant the affected families the closure that is rightfully theirs.

If you are interested in reading more about this injustice, Sharon Hartles has published several articles on the Harm and Evidence Research Collaborative blog that may be of interest:

Primodos: Financial redress is long overdue

Primodos, Mesh and Sodium Valproate: Recommendations and the UK Government’s response

Primodos: The next steps towards Justice

Primodos: The first step towards Justice

This blog was originally published by the Harm and Evidence Research Collaborative at The Open University. See  https://www.open.ac.uk/researchcentres/herc/blog/primodos-2023-fight-justice-continues-association-children-damaged-hormone-pregnancy-tests