This blog post was originally written for Working Chance by Úna Barr and Natalie Rutter and is reproduced here with their kind permission

Úna Barr is a member of the CCSE and a Lecturer in Criminology at Liverpool John Moores University and Natalie Rutter is a Lecturer in Criminology at Leeds Trinity University.

TRIGGER WARNING: this blog post deals with themes of domestic violence, sexual abuse and trauma that some people may find upsetting.

Desistance from crime means any moves away from offending. Research on desistance from crime has informed criminal justice policy and practice in Britain and beyond. Early desistance studies focused on the experiences of white men and linked changes in offending behaviour with getting older, maturity, employment, and getting married (especially to a ‘good woman’). Research also found links with changes in patterns of thinking, including around hope and changes in how criminalised men saw themselves (McNeil and Weaver, 2010). Recently, research has now started to consider the desistance experiences of women. Feminist research has considered the role of gender on desistance experiences.

Our research (Rutter and Barr, 2021) focussed on women’s desistance, relationships, and probation service delivery. We found that within both research on desistance, and the stories women told about themselves, were references to an idea of the ‘good woman’. The male-focussed desistance research references ‘good women’ who support, practically and emotionally, their male partner’s desistance. Some of the women in our research supported male partner’s desistance whilst managing their own desistance from crime. In women’s own stories, the ‘good woman’ was also a good partner, a ‘perfect mum’ (Anna) or a good worker.

When desistance research focuses mainly on the experiences of white men, it overlooks inequalities in society. This puts the responsibility for individuals to change entirely on themselves, or their partners, without considering how gender, class, or race inequalities can effect both criminal justice and desistance experiences.

The women we interviewed experienced harm including domestic violence, poverty, loss of children, bereavement and trauma. The shame and stigma they experienced was related both to their criminalisation (offence and contact with the criminal justice system) and their victimisation (experiences as victims of crime and harm). It also affected their relationships. Overall, this meant that desistance was harder. Yet, we also found that desistance could occur under very harmful circumstances, for example where domestic violence continued.


Karen contrasted her difficulties in desisting from crime and being a ‘normal woman’ who wanted to ‘get married… go shopping, live a normal life, do things that normal women do’. The concept of a ‘good women’ can restrict criminalised women’s prospects of desistance from crime and harm.

Karen also associated her victimhood with choice:



Intersectional feminist research (which does consider gender, as well as race and class and other inequalities) (Phipps, 2014) argues that in capitalist societies, which place emphasis on the individual, women, when faced with (gendered) violence, ‘choose’ to be a victim or survivor. This false choice in Karen’s experience was reflected in other criminalised women’s stories. Without practical support, this could restrict women’s abilities to desist from crime and harm.


The shame and stigma women felt was gendered – i.e. criminalised women were stigmatised twice – for being both ‘an offender’ and a ‘female offender’, demonstrating the importance of societal inequalities in shaping stigma (Tyler, 2020).

In Jess’ case her inability to live up to the ideal ‘good woman’ and the shame she felt, including presenting the ‘perfect family’ resulted in distrust and toxicity in her relationship with her partner.




Women often talked about the abuse they faced. This affected the start or continuation of offending, and also resulted in women being wary of relationships with others.



Whilst desistance research on men places emphasis on the importance of relationships, the reality for women who are in contact with the criminal justice system is often abusive relationships. It is important to consider the conditions that may affect women’s lack of supportive relationships, including ongoing and past victimisation.


Other women experienced positive relationships that helped challenge and resist stigma and shame.



For Karen, the positive relationship with her probation officer was not enough to help her towards desistance from crime. There was a lack of real practical support to help the move away from crime and harmful experiences.

Our research shows that there is a knowledge gap between the established male desistance literature and the realities of women’s lives (Barr, 2019; Barr and Christian, 2019). There must be an understanding of how gender, class, race and other inequalities inform our understandings of what a ‘good woman’ is. These ideas should be challenged in theory and in practice. Positive relationships which challenge feelings of shame and stigma are essential to women’s desistance both from crime and harm. This can be achieved through trust, being respected, not being judged, showing understanding and the importance of time (Rutter, 2019). Rather than desistance research and practice based on individualised responsibility, we repeat Hart’s (2017) call for critical desistance strategies, which reflect the reality of women’s experiences and are based on compassion, love and support.


Barr, U. (2019) Desisting Sisters: Gender, Power and Desistance in the Criminal (In)Justice System. London: Palgrave Macmillan.

Barr, U. and Christian, N. (2019) A qualitative investigation into the impact of domestic abuse on women’s desistance. Probation Journal 66: 416–433.

Hart, E.L. (2017) Prisoners post release: the need for a critical desistance. In: Hart, EL, van Ginneken, EFJC (eds) New Perspectives on Desistance: Theoretical and Empirical Developments. London: Palgrave Macmillan, pp. 267–288.

McNeill, F. and Weaver, B. (2010) Changing Lives? Desistance Research and Offender Management. SCCJR Project Report; NO.03/2010.

Phipps, A. (2014) The Politics of the Body: Gender in a Neoliberal and Neoconservative Age. Cambridge, MA: Polity Press.

Rutter, N. (2019) The Golden Thread: service user narratives on desistance, the role of relationships and opportunities for co-produced rehabilitation. Doctoral Thesis, Manchester Metropolitan University, UK.

Rutter, N. and Barr, U. (2021) Being a ‘good woman’: Stigma, relationships and desistance. Probation Journal. 68 (2):166-185.

Tyler, I. (2020) Stigma: The Machinery of Inequality. London: Zed Books

Primodos:  Financial redress is long overdue

Sharon Hartles, Member of the Harm and Evidence Research Collaborative,
The Open University

Images adapted from sources: ​First Do No Harm reportIndependent Medicines and Medical Devices Safety Review poster and the Government response to the report of the Independent Medicines and Medical Devices Safety Review

Following the publication of the First Do No Harm  report (also known as the Cumberlege Review), Baroness  Julia Cumberlege CBE, a life peer who chaired the Independent Medicines and Medical Devices Safety Review, stated “The first duty of any health system is to do no harm to those in its care; but I am sorry to say that in too many cases concerning Primodos, sodium valproate and pelvic mesh, our system has failed in its responsibilities.” Within hours of the report being released, on the 8th July 2020, the then Secretary of State for Health and Social Care Matt Hancock issued a full apology which met with Recommendation 1, the first of nine strategic recommendations set out in the First Do No Harm report. For Marie Lyon, Chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT) who has been campaigning for justice since 1978, the report content and acknowledgment triggered an emotive response. However, time would evidence that this initial euphoria was going to be replaced with a vehement sense of betrayal and a continuation of Primodos affected families campaigning for justice in the form of financial redress.

On the first anniversary of the publication of the First Do No Harm Report, in an Independent Medicines and Medical Devices Safety Review Debate, Nadine Dorries, Minister of State at the Department of Health and Social Care, expressed her sympathy to those who had been harmed. During this backbench debate which took place in the House of Commons, she announced that the government would not be implementing recommendation 3 or recommendation 4 as set out in the First Do No Harm report (see figure 1). This harmful decision not to implement these recommendations was confirmed on the 21st July 2021, in the Government response to the report of the Independent Medicines and Medical Devices Safety Review published by the Department of Health and Social Care.

Figure 1 – Extract from the Government response to the report of the Independent Medicines and Medical Devices Safety Review (p. 8)

Just as the government did not accept the recommendations for a Redress Agency and Separate schemes, those who have suffered and their families have decided not to accept the government’s response in regards to these recommendations. Marie Lyon voiced her reaction “Redress is the most powerful way of making amends and freeing our families from the financial burden they have carried and will continue to carry for many years to come”. Her disappointment was echoed in a Statement by Baroness Julia Cumberlege CBE and the Rt Hon Jemery Hunt MP“… we are deeply disappointed the government has rejected calls for an independent redress agency or any redress for families whose lives have been devastated by medicines or medical devices. For those families justice has not been done today.”

In addition to Baroness Julia Cumberlege CBE and Jemery Hunt MP, a wide array of parliamentarians continue to actively support the Primodos campaign for justice, including but not exclusive to:  Lord David Alton MP, Former Prime Minister Theresa May,  Sir Mike Penning MP, Hannah Bardell MP, Yasmin Qureshi MP, Emma Hardy MP, Sarah Green MP, Ed Davey MP, Yvonne Fovargue MP, Caroline Nokes MP, Sharon Hodgson and Allan Dorans MP.

On the 17th February 2022, a joint letter was written from Marie Lyon (ACDHPT), Kath Sansom (Sling the Mesh) and Emma Murphy and Janet William (In-fact), to Maria Caulfield MP, Parliament Secretary of State for Patient Safety and Primary Care. In this letter, these three campaign groups collectively called for the recommendations set out in the Independent Medicines and Medical Devices Safety Review to be implemented in full. It is clear that Primodos affected families will not give up on anything less than justice, as recommended in the First Do No Harm report.

The personal testimonies which formed part of the evidence for the Independent Medicines and Medical Devices Safety Review from Nicky GubbinsDaniel MasonLinda KellyChristine Feltham, and the Bagley family, together with the personal testimonies of Chris GoochJo Moreno and Margaret Roberts make visible social harm. A range of harms are evident including: physical, emotional and psychological, cultural and relational, and financial and economic. While some of these harms are readily apparent, others have unfolded over decades and will continue to do so. The health care system failed in its responsibility to prevent those in its care from being harmed. Despite being informed of this on the 8th July 2020, in the First Do No Harm report, it is now the government who is failing in its duty to do no harm, to those who are still suffering and their families.

Since the publication of the First Do No Harm report, 19 parents of children damaged by Primodos have died. In a Patient Safety Commissioner debate, which took place in the House of Lords, Lord David Alton concluded the parents died “while still worrying that their children would be left financially dependent on the state? They died in despair.” It is clear that the inaction of the government not to accept in full the recommendations set out in the Independent Medicines and Medical Devices Safety Review is exacerbating and prolonging avoidable harm which the government is now imposing onto Primodos affected families.
In the Government response to the report of the Independent Medicines and Medical Devices Safety Review, instead of implementing financial redress to those who were not protected by the health system, the government stated its ‘priority is to make medicines and devices safer and the government is pursuing a wide range of activity to further this aim’ (figure 1). It is important that the government have recognised that patients are the raison d’être of the health system. However, this should not be advocated as a priority at the expense of financially redressing those harmed and their families. The government does not need to make an either-or choice, both points are equally important and are not mutually exclusive. Make medicines and devices safer ‘and’ set up schemes to meet the cost of providing additional care to those who have been harmed.

The avoidable harms brought about due to systemic failure spanning decades, and which have led to a multitude of intergenerational harms, cannot be brushed aside under the old cliché that lessons have been learned by the government. Primodos affected families have fought tirelessly for many decades to have their voices amplified, to be heard, to be listened to, to be believed, to share their lived experiences. Justice in the form of financial redress is long overdue. The government should do no harm, but then do some good, not only for future patients of the health system, but also for those who have suffered because the health system failed in its duty and in its responsibilities to do no harm to those in its care.

If you wish to read more about this injustice, the following articles published by Sharon Hartles on the Harm and Evidence Research Collaborative blog may be of interest:

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-financial-redress-long-overdue

Unleashing State Hell: Attica 50 Years On

Joe Sim, Professor of Criminology, Liverpool John Moores University

The 50th anniversary of the barbaric suppression of the Attica prison uprising occurred on September 13th 2021. The uprising, and the ferocious response by the American state, whose agents shot dead 43 prisoners and hostages, had a seismic impact on the radical prisoners’ rights movement which was emerging in the UK, and internationally, at that time, a movement which remains central to the struggles around prisons today.  Attica brutally illustrated the terror and violence the state could mobilise when its legitimacy was challenged, the cheapness of prisoners’ lives and the blatant hypocrisy of a system that claimed to be rehabilitative but which was, in practice, based on the systemic delivery of punishment and pain. The punishment and pain experienced by Black prisoners was underpinned by institutionalised, racist dehumanization and degradation. A culture of almost complete immunity and impunity protected those who were responsible for the carnage aided and abetted by an uncritical, supine mass media.

Below is a review of Heather Ann Thompson’s magnificent book Blood in the Water: The Attica Prison Uprising of 1971 and Its Legacy which was published in 2016. The book systematically details the devastating events at Attica and the brutal aftermath. It provides a fitting and elegiac testimony not only to the dead and the survivors but also to their relatives and friends as well as shining a shimmering and unforgettable light on the endurance of the human spirit.

Blood in the Water: The Attica Prison Uprising of 1971 and Its Legacy by Heather Ann Thompson Pantheon Books[i]

Joe Sim

According to Franz Fanon, ‘we revolt simply because, for many reasons, we can no longer breathe’.[ii] Fanon’s insight is directly relevant to the barbaric events which unfolded at Attica prison in New York State in September 1971 when prisoners revolted against the suffocating conditions of their confinement. For four days they controlled the institution from D Yard before the state unleashed hell and launched a ferocious assault to retake the prison. The attack left 43 prisoners and hostages dead and 128 wounded, many seriously. Heather Anne Thompson’s monumental, haunting and deeply moving study, based on 10 years of meticulous research, provides a compelling analysis of the roots of the revolt, the brutal, remorseless revenge enacted by the state, the deceit and lies peddled to cover up how the prisoners and hostages died and the iron resolve of survivors and the families of the dead prisoners and hostages to achieve ‘truth, justice and accountability’.[iii] It is a story of institutionalized violence and torture, deeply embedded racism and state collusion, conspiracy and cover-up which has taken 45 years to finally bring into the light.

Why did the revolt happen? Its roots lay in the challenges posed by the civil rights movement and the increasing influence of the Black Panther Party, many of whose members were confined in Attica and who refused to accept the degrading treatment, casual sadism and systemic racism dispensed on a daily basis. Conditions were appalling. Prisoners were given one bar of soap each month and one roll of toilet paper which meant that they had to ‘limit themselves to ‘one sheet per day’. Expenditure on food amounted to ‘a mere 63 cents per prisoner per day…’ (p. 8). The book is based on a range of unpublished sources and documents which were stored, often dismissively, in boxes and store-rooms around the USA. Among the items Thompson discovered were the still-bloodied clothes of L.D. Bartley whose rousing and defiant oratory poignantly articulated the perspective of the prisoners: ‘We are men. We are not beasts and we do not intend to be beaten or driven as such. The entire prison populace, that means each and every one of us here, has set forth to change forever the ruthless brutalization and disregard for the lives of the prisoners here and throughout the United States. What has happened here is but the sound before the fury of those who are oppressed’ (p. 78). His defiance cost him his life when he was killed after the prison had been retaken. His, and the other deaths, were a direct result of the devastating and illegal firepower mobilized by the state.

The assault on D yard was led by troopers who were ‘armed with .270 caliber rifles, which utilized unjacketed bullets, a kind of ammunition that causes such enormous damage to human flesh that it was banned by the Geneva Conventions’ (p. 157). Between 2,349 and 3,132 lethal (shotgun) pellets were fired. There were also 8 rounds fired ‘from a .357 caliber, twenty-seven rounds from a .38 caliber, and sixty-eight rounds from a .270 caliber….these counts did not even include the bullets from correction officers and other members of law enforcement not fully accounted for’ (p. 526).

The relentless brutality of the state’s assault was not the result of deranged individuals engaging in renegade behavior — the politically reductive and theoretically naïve ‘bad apple’ theory of state deviance propagated by an endless procession of politicians, media personnel and academics, linked together by a positivist, umbilical cord which defines state actions as inherently benevolent which are occasionally tainted by the activities of a pathological few. Rather, terror, torture and brutality were systemic to the state’s brutal response. This was based on a process of conspiratorial, racist collusion which was integral to the actions of those who were on the ground on the day relentlessly abusing and killing prisoners and hostages and which moved remorselessly up through the ranks of the police, and state troopers, into the offices of the prosecuting authorities and finally to the highest reaches of the US government itself whose views were mobilized to legitimate the brutal actions of those on the ground.

As Nelson Rockefeller, the state governor, mendaciously told a grateful President Nixon in the aftermath of the state’s assault, ’the whole thing was led by the blacks’ and that state troopers had been deployed ‘only when they [the prisoners] were in the process of murdering the guards’ (p. 200). As ever, when the state kills, its agents are immediately deployed to spread lies, and engage in deceit, exaggeration and distortion, a toxic mix designed to both mystify what happened and to mobilise a narrative for media and popular consumption that the violence of its servants was, given the dangers they were facing especially from black prisoners, legitimate.

Yet, as the book makes abundantly clear, even at the height of the carnage in D Yard, it was not the prisoners — pejoratively labelled as liars, psychopaths and animals — who were murdering the hostages. Rather, prisoners attempted to safeguard them while putting their own lives in grave danger. However, even this selfless act of bravery and humanity was buried under the weight of the perfidious deceit of the state’s spokespersons who unashamedly peddled the lie that the hostages had had their throats cut or had been castrated by the very prisoners who had attempted to protect them. The pitiless response to the prisoners, and the unshackled violence they experienced, was based on the scornful, mortifying and degrading vilification of their helpless bodies, dead and alive. According to one eyewitness, Tommy Hicks, a prisoner who was still alive after the prison was retaken, was ‘“hit with a barrage of gunfire” after which he saw troopers walk over to Hicks’s body take “the butt end of the gun, pound the flesh in the ground, kick it, pound it, shoot it again”’. Survivors were made to crawl naked through a mud-filled yard towards state servants where they were savagely beaten.

This brutality extended even to the most severely wounded who were given no sedatives and who were ‘expected to suffer through the pain’. In contrast, state troopers, whose injuries included a ‘fractured finger, bruised knee [and] a fractured toe’, were prioritized (pps. 206–7). The role of medical staff before and after the revolt, and their abject capitulation to the state’s dehumanizing goals, is made abundantly clear in the book. They were active agents in the brutalization of the prisoners. Thompson beautifully crafts the forgotten and moving story of the survivors into a devastating indictment of the naked exercise of power from state servants who acted with total impunity before, during and after the revolt towards them. The chilling calculation around life and death extended to its own surviving, employees who were only paid for eight hours for each day they were held hostage as the rest of the time ‘they were technically off the clock’ (p. 538).

The campaigns by the survivors and families, spread over nearly half a century, demanded a reckoning with state servants, whose every action, despite the occasional, honorable, individual exception, was built on denying truth, subverting justice, intimidating those who disagreed with the dominant narrative, burying and destroying evidence, destabilizing different campaigns and attempting to ensure that those responsible for the carnage would escape justice. This was done through ‘refusing to hand over materials expeditiously — even when required by law to do so…..’ (pps. 315–316) and ensuring that funding was minimal for lawyers who were acting for the families. The book concludes by focusing on the legacy of the revolt.

The liberal, humanizing reforms proposed by the state quickly dissipated under the collective, regressive weight of resurgent law and order campaigns, the ongoing war on drugs, the hostility towards prisoners and the drive towards mass incarceration through a racist process of criminalization which targeted the powerless while leaving the powerful, as ever, free to engage in rampant acts of criminality. Mass incarceration legitimates institutionalized racism and institutionalized racism legitimates mass incarceration while the police and the courts provide the glue that holds the whole, racist edifice together. And yet collective webs of resistance still persist. The strikes which took place in late 2016 across 22 prisons — the biggest in US prison history — against slave labour conditions, links directly back to Attica. So too does the principled activities of Black Lives Matter contesting the ongoing, systemic racism, and state-induced death, disproportionately experienced by African Americans.

Nearly half a century on, the aching desolation generated by the barbarity perpetrated by the state at Attica still lingers in all of its melancholic toxicity. At the same time, the righteous anger and the relentless desire to ensure that Attica is not forgotten, is an eloquent testimony to the human spirit’s enduring sense that injustice needs to be confronted, wrongs righted and responsibility attributed. Voltaire’s famous quote — ‘to the living we owe respect but to the dead we owe only the truth’ — provides a fitting tribute to all of those who have struggled over the last 50 years to right Attica’s wrongs. It is also a fitting testimony to this magnificent book, and to Heather Thompson’s rigorous scholarship and extraordinary commitment which runs like a clear stream from the book’s first through to its last sentence.

[i] This review was originally published in the Prison Service Journal, Issue 231, May 2017, pp 41-44.

[ii] Franz Fanon cited in Kyerewaa, K. (2016) ‘Black Lives Matter UK’ in Red Pepper, Issue 210 October/November 2016 p. 8.

[iii] This is the slogan which the charity INQUEST campaigns around. The charity provides ‘expertise on state related deaths and their investigation to bereaved people, lawyers, advice and support agencies, the media and parliamentarians’ (inquest.org.uk).

This blog has also been published by the Harm and Evidence Research Collaborative at The Open University. See http://www.open.ac.uk/researchcentres/herc/blog  

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

Sharon Hartles, Member of the Harm and Evidence Research Collaborative,
The Open University

Images sources: First Do No Harm report, Independent Medicines and Medical Devices Safety Review poster and Government response to the report of the Independent Medicines and Medical Devices Safety Review

Following patient-led campaigns, on the 22nd February 2018, Jeremy Hunt, the then, Secretary of State for Health, commissioned a review into the potentially harmful side effects of three NHS treatments: Primodos; Mesh and Sodium Valproate. As a result, on the 8th July 2020, the Independent Medicines and Medical Devices Safety Review published the First Do No Harm report. According to Baroness Cumberlege, a life peer who chaired the Review, the 9 strategic recommendations and 50 actions for improvement set out in the report were carefully designed to ensure the objectives could be achieved. The major recommendations include:

Image content taken from: Independent Medicines and Medical Devices Safety Review publishes its recommendations (08/07/2020)

On the same day as the publication of the report, Matt Hancock, the then, Secretary of State for Health and Social Care, immediately responded with a public apology. He apologised on behalf of the NHS and the healthcare system to those who have suffered avoidable harm. The patient-led campaign groups welcomed this apology, in part because the immediate issuing of a fulsome apology fulfilled recommendation 1 of the First Do No Harm report. However, it soon became clear that the implementation of the remaining eight recommendations set out in the report would be fraught with resistance.

Finally, on the 21st July 2021, the Department of Health and Social Care published the Government response to the report of the Independent Medicines and Medical Devices Safety Review. A summary of the Government’s response makes apparent that the recommendations were not accepted in full as Primodos, Mesh and Sodium Valproate campaigners and advocates have tirelessly fought for:

  • Recommendation 1: Government response – Accept
  • Recommendation 2: Government response – Accept
  • Recommendation 3: Government response – Do Not Accept
  • Recommendation 4: Government response – Do Not Accept
  • Recommendation 5: Government response – Accept In Part
  • Recommendation 6: Government response – Accept
  • Recommendation 7: Government response – Accept
  • Recommendation 8: Government response – Accept In Principle
  • Recommendation 9: Government response – Accept In Part

(Order layout as in the image above).

In response to the Government’s publication, Marie Lyon, Chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests kindly provided the following statement (26th July 2021):  

My message is to the UK Government. You have proved you are morally bankrupt. Failing to implement Redress is a betrayal of the Unconditional Apology issued by both Matt Hancock and Nadine Dorries. Definition of an unconditional apology* Accepting the responsibility for YOUR Actions* The failures of the UK Regulator is YOUR responsibility. Redress is the most powerful way of making amends and freeing our families from the financial burden they have carried and will continue to carry for many years to come.  The decision not to implement Redress came directly from No. 10, who are far removed from the privations our families suffer and care even less.  Implementation of the 9 recommendations is about more than just 3 medical mistakes, it is about the safety of EVERY Patient in the U.K.  Unless the UK Government acknowledge and accept responsibility for these failures by providing redress, nothing will change and Patients will continue to be at risk. Progress has been made in accepting some of the recommendations, which was due to the influence of the Patient Reference Group, appointed to provide challenge, advice and scrutiny to the Government’s response to the Report. The PRG challenged each proposal for every individual recommendation, which resulted in the 4 recommendations accepted and 3 accepted in part or in principle. The failure to implement Redress proves that money is more important than accepting moral responsibility.

On the 21st July 2021, in a twitter post, Sling the Mesh (a campaign group founded by Kath Sansom) shared the following reaction to the Government’s response to the Independent Medicines and Medical Devices Safety Review report.

When asked to comment further Kath Sansom said: “It was cowardly for the government to only give a written response just before they broke up for summer recess. To ignore financial redress is incredibly cruel to all those families affected by Mesh, Primodos and Sodium Valproate. The battle is not yet over!”

Emma Murphy, Managing Director of INFACT-UK, (a National Campaign Group representing people in the UK harmed by Sodium Valproate) forwarded on the following statement (23rd July 2021):

The Government response to the Cumberlege Review is a cruel bitter blow to the thousands of children and families harmed by Sodium Valproate in Pregnancy. Despite Government accepting the Science and the damage it causes in Utero to a baby, and the lifelong damaging effects to the children. The INFACT campaign has proved Government had knowledge of the risks at licensing (1973) yet suppressed this information to the patient, and continued to allow Valproate to be prescribed without adequate warnings despite among other things the proven 40% risk of Autism to the unborn child. The very systems that were set up to protect and safeguard our children, ultimately disabled them.

In a House of Commons debate, Nadine Dorries, Minister of State at the Department of Health and Social Care, stated “I was honest and I stood here and said how desperately sorry I am and how harrowing those stories are. … I will be honest: we are not going to accept the redress agency in recommendation three, or the taskforce.” It is evident that a public expression of sympathy in no way replaces the need to financially redress those who have been harmed.  

Primodos, Mesh and Sodium Valproate campaigners have warmly welcomed the Government’s acceptance of four of the nine recommendations and a further two in part and one in principle. The acceptance of recommendation 2, the confirmation that a Patient Safety Commissioner will be appointed, in a bid to reduce the risk of avoidable harm in the future is encouraging.  However, the campaigners are united in their bitter disappointment of the UK Government’s rejection of the remainder of the recommendations, in particular the recommendations which would have eased their financial burden. For this reason Primodos, Mesh and Sodium Valproate campaigners and those championing these plights will continue in their pursuit for justice.

If you wish to read more about these injustices, the following articles published by the Harm and Evidence Research Collaborative may be of interest:

Sodium Valproate: The Fetal Valproate Syndrome Tragedy

Mesh: Denial, half-truths and the harms

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-mesh-and-sodium-valproate-recommendations-and-uk-government%E2%80%99s-response

Sodium Valproate: The Fetal Valproate Syndrome Tragedy

Sharon Hartles, Member of the Harm and Evidence Research Collaborative,
The Open University

In the UK, Epilim is the dominant sodium valproate medication used to treat patients at risk of epilepsy associated convulsions. Epilim is an effective anti-convulsant medicine (epilepsy drug) and for this reason it has been licensed for usage since 1973. However, Epilim is also a teratogen; thus exposure to this drug causes an increased risk of physical, developmental and neurological harms in the human embryo or fetus.

Sodium valproate, marketed as Epilim in the UK, has been linked to physical, developmental and neurological harms in the human fetus. ALAMY https://www.thetimes.co.uk/article/sinn-f-in-senator-urges-inquiry-for-epilim-babies-hr6vlklmf

Given the fact that sodium valproate is harmful, wherever possible it clearly should not be prescribed to female patients of childbearing age.  Despite this, the regulators and Sanofi, the company responsible for manufacturing and marketing Epilim (Sanofi acquired the company from Reckitt-Labaz in or around 1980) chose to keep patients in the dark for decades and did not disclose the known associations. As a consequence, patients were unable to make informed choices, which has resulted in the preventable fetal valproate syndrome tragedy.

According to The independent Medicines and Medical Devices Safety Review, congenital birth defects associated with in utero exposure to sodium valproate include:

  • Neural tube defects (NTDs), such as spina bifida 
  • Cleft lip and palate
  • Facial and skull malformations
  • Heart, kidney, urinary tract and sexual organ malformations
  • Limb defects
  • Developmental delay
  • Autism Spectrum Disorders (ASDs)
  • Attention Deficit Hyperactivity Disorder
  • Ear malformations and auditory processing
  • Skeletal malformation
  • Arthritis in older children
  • Effects on the endocrine system
  • Sexual identity problems (which occur due to a mismatch between genital development and neural / sexual identity development).
  • Psychomotor issues.
  • Withdrawal symptoms – associated with prenatal sodium valproate exposure.

Fetal valproate syndrome harms are widely accepted within the clinical and regulatory community, including by: the National Institute for Health and Clinical Excellence (NICE), the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

During the 1960s and 1970s, articles were published drawing attention to the concerns about the teratogenicity and anti-epileptic (anti-convulsant) medication this included research by: Lawrence, 1963, Janz and Fuchs 1964, Meadow 1968, Speidel and Meadow 1972,  Lowe, 1973, Fedrick 1973, Hill 1974, Barr, 1974 and Hanson and Smith 1975. Yet, despite the known harms, documents uncovered from The National Archives revealed that in 1973, the Committee on Safety of Medicines (a precursor to the  Medicines & Healthcare products Regulatory Agency) thought it best not to make patients aware of the dangers because “it could give rise to fruitless anxiety”. 

The controversy surrounding the abhorrent failure to communicate the preventable risks to clinicians and patients was evidenced again because by the early 1980s the regulator and manufacturer was in possession of sufficient information to conclude that Epilim increased the risk of congenital abnormalities. Even though the links between the exposure to sodium valproate and the increased risk of harms to a fetus were well-documented, patients were not informed directly of the link until 2005. In some cases care pathways for women of child-bearing age were not established until 2016. In February 2018, the European Medicines Agency put in measures to avoid valproate exposure in pregnancy.

A visual warning of the pregnancy risks (in the form of text) with other warning symbol on the outer carton. https://www.chemistanddruggist.co.uk/cpd-article/valproate-pregnancy-prevention-programme

The fetal valproate syndrome tragedy (medical negligence) was entirely avoidable, resulting from a regulation failure and decades of inaction by successive governments to safeguard patients. The true number of individuals’ harmed by sodium valproate in utero since it was licensed in 1973 in the UK is unknown, however, the consensus estimate is around 20,000.  More recent evidence suggests that the medical problems associated with fetal valproate syndrome may be passed down the generations.

Those affected by fetal valproate syndrome have paid the highest price for the regulator and the manufacturer’s negligence and will continue to do so. In the words of a member of the Organisation for Anti-Convulsant Syndrome (OACS Charity):

‘I am mourning my child now and will be mourning the death of

her when she’s gone, this is the result of Valproate, no parent

wants to see their child slowly die in front of them’.

The role that the regulator and the manufacturer Sanofi have played in creating and perpetuating this tragedy is evident, therefore financial redress should be paid to all those affected by fetal valproate syndrome.

Currently, 27,000 women of child bearing age are taking valproate in the UK. On 2nd March 2021, in the House of Lords, James O’Shaughnessy, Vice-chair for the All-Party Parliamentary Group for First Do No Harm, reported that since June 2020, 150 babies had been born suffering harms due to sodium valproate exposure. Therefore it is imperative that the Government find ways to minimise the risk of harms to future babies. Beyond this, lessons must be learned and mechanisms put into place to ensure avoidable systemic failures on this scale do not happen again. 

There are a number of places throughout the UK and globally which offer general advice and support to individuals and family members affected by fetal valproate syndrome harms. These include: 

Bipolar, UK

Epilepsy, UK

Epilepsy Society, UK


FACS – Fetal Anti-Convulsant Syndrome Association, UK

In-FACT – Independent Fetal Anti-Convulsant Trust, UK

OACS – Organisation for Anti-Convulsant Syndromes, UK

Epilepsy, Ireland

FACS Forum, Epilepsy, Ireland

OACS Organisation Anti-Convulsant Syndrome, Ireland

Epilepsy, Scotland

APESAC – Association of Parents of Children with the Syndrome Anti-Convulsant, France

ABVSV/BVSVS – Belgian Association of Victims of Valproate Syndrome, Belgium

IBE – International Bureau for Epilepsy

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/sodium-valproate-fetal-valproate-syndrome-tragedy

Policing, Violence and State ‘Truths’

Joe Sim, Professor of Criminology, Liverpool John Moores University,; Steve Tombs, Professor of Criminology, The Open University

For us, the recent demonstrations in Bristol raise at least two important issues about violence and ‘safety’ in the UK as we write.

First, the Police, Crime, Sentencing and Courts Bill marks a further intensification and escalation in the state’s authoritarian, paramilitarised response to maintaining public order. This has been a constant focus of political and popular debate for decades, resulting in a layer of oppressive and restrictive legislation and the uncritical valorisation of the world of public order.

In contrast, the often-brutal maintenance of private order in the home through the fear and use of male violence still remains shrouded in political silence, and systemic indifference, despite the rhetoric of successive governments that the state is taking it seriously. The UK Femicide Survey, covering the years 2009-2018, paints a damning picture of the still-neglected violence happening daily in the world of the private which has not generated the same popular and political response:

By far the most common relationship consistently over the ten years between the perpetrator and the victim was that of current or ex-spouse or intimate partner being 888 of 1,425 cases (62%). The next most common relationship between victim and perpetrator was familial (10%) with 111 women being killed by their sons and a further 32 women killed by another male relative. Only 8% of cases involved total strangers

It is also worth noting that the state’s concern with safety and order in the world of the public only extends so far. Safety can also be compromised by hate crimes, which, like violence in the world of the private, still receives scant political and popular attention. In 2019/20, there were 105,090 hate crimes recorded by the police in England and Wales excluding Greater Manchester. This represented an increase of eight per cent compared with the previous year. The majority of these crimes were ‘race hate crimes, accounting for around three-quarters of offences (72%; 76,070 offences).’

State ‘Truths’

The second issue raised by the state’s response to the demonstrations was the  relentless and insidious attempt to construct a ‘truth’ about the nature and extent of the violence experienced by its agents, through a toxic combination of exaggerating and overdramatising the violence committed by the protestors and the seriousness of the injuries sustained by police on the ground. Exaggerating and over-dramatising injuries sustained by state agents has been central to the state’s ideological armoury for decades. The state’s mendacity around who is to blame for public disorder, based on the pejorative construction of ‘negative reputations’, and  uncritically disseminated by the mass media, also has a long history as the reporting of the year-long miners strike in 1984/5, Stonehenge, Hillsborough and the death of Ian Tomlinson have demonstrated.

Both the major political parties in England and Wales have unequivocally supported this ‘truth’ about the dangers posed to its agents. And while the Bristol police had to retract their mendacious claim that a number of officers had been seriously injured during the protests, the ideological damage had been done.

Additionally, the violence committed by state agents is individualised. State violence is focussed on those agents who step outside the acceptable limits of state violence and coercion. This means that any critical consideration of the unfettered discretion, the authoritarian, occupational culture and the lack of democratic accountability that prevails within the police and prisons is effectively ignored in favour of a narrative based on a few ‘bad apples’ whose behaviour is dismissed as an aberration from an essentially benevolent state norm. This guarantees ongoing immunity and impunity for the broad mass of state agents in favour of the ‘deviant’, unacceptable individual.


One of the most outrageous examples of media manipulation occurred after demonstrations at Kingsnorth power station in 2008. As The Guardian revealed at the time, the police claimed that out of the 1500 officers policing the demonstration, 70 had been injured by demonstrators. In fact, there were 12 reportable injuries, only four of which were sustained through direct contact with protestors and they were at the lowest level of seriousness. Other injuries included ‘being “stung on finger by a possible wasp”, “officer injured sitting in car” and “officer succumbed to sun and heat”; one officer cut his arm on a fence when climbing over it, another cut his finger while mending a car, and one “used leg to open door and next day had pain in lower back”. A separate breakdown of the 33 patients treated by the police tactical medicine unit showed that three officers had succumbed to heat exhaustion, three had toothache, six were bitten by insects, and others had diarrhoea, had cut their finger or had headaches’.  

The claim that protestors come to demonstrations ‘tooled up’ with dangerous weapons – a familiar state and media stereotype – was also not in evidence at Kingsnorth. The ‘dangerous’ items confiscated from the protestors included: toilet rolls, board games, clown costumes, glue, marker pens, cushions, carpet, wood, paint, scissors and bicycle locks  as well as ‘anything that could have been used to set up camp, including spades and duct tape, generators and hammers and nails’. This information was only revealed after a Freedom of Information (FOI) request.

Christine Berry, who was involved in exposing the state’s mendacity, has pointed out that[i]:

A strikingly similar playbook was used in Bristol last month, where police claimed to have suffered a punctured lung and broken bones. They later admitted these claims were baseless, but by then the damage was done: swathes of media reports had successfully implanted the idea that the protesters were violent, and anyone defending them was subjected to social media pile-ons.

Finally, the hugely controversial report by the Commission on Race and Ethnic Disparities, published on March 31 continued the state-defined trend. It contained data which reinforced the narrative about the dangers police officers faced. The chapter on Crime and Policing, which at over 60 pages was the longest in the report, compared with chapters on Education and Training (50 pages), Employment, Fairness at Work and Enterprise (30 pages) and Health (34 pages), finished with a section on ‘the risks of doing the job’. Not unsurprisingly, the Commission, citing data from the Police Federation, argued that, in 2017, a police officer ‘was assaulted every four minutes’. Five other sources, over and above the source from the Federation, were cited as evidence regarding the risks police officers faced: two from the Home Office, two from the Daily Telegraph and one from the BBC.


In 2005, Leo Panitch and Colin Leys pointed to the ‘unprecedented levels of secrecy, obfuscation, dissembling and outright lying that now characterize public life…a generalized pathology of chronic mendacity [which] seems to be a structural condition of global capitalism at the beginning of the 21st century…’.

Sixteen years on, the state’s elasticated relationship with the truth has arguably become even more problematic, a point poignantly and powerfully illustrated by the pandemic, particularly around the number of dead, and, crucially, how they died.  For example, the government has consistently denied that there was rationing of intensive care for the elderly. And yet, there is evidence to suggest that rationing of life-saving care was ‘widespread’ in hospitals. Thus:

just one in six Covid-19 patients who lost their lives in hospital during the first wave had been given intensive care treatment. This suggest that of the 47,000 people who died of the virus inside and outside of hospitals, an estimated 5000 –  just one in nine –  received the highest critical care, despite the government claiming that intensive care capacity was never breached.

One doctor commented on how the government’s narrative was facilitated by daily press briefings where:

…you just couldn’t recognize anything that they were saying. It was so discordant with what we were seeing. They’d made it all up. It was completely bizarre – picking certain statistics to highlight how well they were doing versus other countries when actually, particularly in London, it was an absolute car crash (ibid, emphasis added).

As we pointed out over a decade ago, claims about the on-the-job risks faced by police officers wholly obscure the fact that, compared to many occupations in the UK, the police experience remarkably low levels of occupational death and injury. In both absolute and relative terms, agriculture, construction, manufacturing, and transportation are by far the most dangerous occupations for fatal and major injuries, whilst police barely figure in the 13,000 or so deaths from occupational exposures recorded every year by the Health and Safety Executive. Therefore, while it should be recognized that some police officers are injured, die and fall ill as a result of work, empirically, compared with the dangers faced by other workers, police work is at the safer end of the occupational spectrum. If their work is to be made safer, and their victimization is to be reduced, then the complexity of the dangers they, and other occupational groups face, needs to be considered as a whole.

The simplistic claim that the issues referred to here are all effects of a ‘post-truth’ society obscures the fact that the UK state has always bent the truth in order to achieve its ends. In 2021, what is important is that the technology currently at the state’s disposal, the decline in investigative journalism, despite some honourable exceptions, and an acquiescent, mainstream media, has facilitated the speed and spread of official discourse which makes it difficult, though not impossible, for counter narratives to emerge. At the same time, the state’s ‘truth’ in this and other areas has not achieved hegemony. Contradictions, contingencies and spaces of contestation, generated by grass roots organizations and community based media alternatives ensure that the state’s definition of reality has not prevailed, at least not yet.

[i] Thanks to Paul Gilroy for pointing out this reference.

This blog has also been published by the Harm and Evidence Research Collaborative at The Open University. See http://www.open.ac.uk/researchcentres/herc/blog  

Mesh: Denial, half-truths and the harms

Sharon Hartles, Member of the Harm and Evidence Research Collaborative, The Open University

Mesh implants used ‘with no clinical evidence’ (Screenshot). Photo Credit: BBC Two Victoria Derbyshire 15th January 2020

Surgical meshes have been in use since the late 19th century. In the mid-20th century the clinical usage of mesh increased. Now, in the early 21st century, procedures involving mesh implantation are common surgeries that are performed around the world. Despite the frequency and worldwide usage of mesh medical devices, the debate about whether or not the benefits outweigh the alleged harms remains highly contested.

Mesh implants are manufactured from synthetic (non-absorbable or synthetic absorbable) and biological materials. Synthetic non-absorbable materials include: polypropylene, polyester, and polytetrafluorethylene. Synthetic absorbable materials include: polylactic-co-glycolic acid and polyhydroxybutyrate. Biological materials include: modified collagen of porcine or human dermal or visceral collagen.

Surgical (open) or laparoscopic (keyhole) approaches are carried out for the clinical applications of mesh implants. Mesh medical devices have been installed in breast reconstruction, abdominal/pelvic hernia repair, and hiatal hernia repair. Regardless of mesh implant technique and location, each material provides its own set of challenges.  As such a complex range of potentially harmful side effects can occur.

The recent publication of the Independent Medicines and Medical Devices Safety Review (IMMDSR) report, First Do No Harm and thesubsequent recommendations were welcomed by individuals and campaign groups effected by: mesh implants, Primodos and the anti-epilepsy drug sodium valproate. However, the mesh focus was centred on abdominal and vaginal pelvic mesh procedures used in the treatment of stress urinary incontinence and pelvic organ prolapse. For this reason the voices and lived experiences of many other mesh-harmed individuals, who did not fall into the particular focus, were not heard and did not form part of the IMMDSR publication.

Mesh-harmed individuals and campaigners experience traumatic, excruciating, unbearable pain and debilitating life changing harms, yet it is not only the medical devices that cause harm. Stubbornness and reluctance to blame implants in certain cases has led to doctors being accused of gaslighting – psychologically abusing mesh patients by questioning their sanity. This is exacerbated by flaws in the healthcare system, in some circumstances stemming from inexperience of professionals; gaps in research linking side effects to medical devices; and contested safety and efficiency status.

Dismissed as ‘women’s problems’, harms resulting from mesh implantations have been suppressed by doctors, leaving patients feeling belittled, ignored and above all disempowered. Relentless campaigning by patient groups has raised awareness of the lack of informed consent and a failure to listen to patients’ voices. In addition to this, campaigners have generated media and public interest into this injustice. This is not just localised to the UK, mesh surgeries are performed worldwide, and thus mesh-harmed activists are campaigning for justice around the world.

On 4th March 2021, in a landmark judgment, the Federal Court of Australia dismissed an appeal by Johnson & Johnson (one of the main manufacturers of vaginal mesh), who was found to have acted negligently. Johnson & Johnson concealed known complications about mesh implants and aggressively marketed their faulty implants successfully based on half-truths. A clear case of profit before harm, Johnson & Johnson had no regard for the serious and debilitating side effects thousands of women would experience from their mesh devices; and instead was driven by profiteering and commercial interests.

Although it is overwhelmingly women’s voices which have been ignored and women’s lived experiences which (until recently) have not been validated; it is paramount to note that mesh medical devices are also implanted into men, children and babies. Therefore it stands to reason that the devastating impacts of mesh are not just experienced by women. In December 2018, Graham Robertson, was left with a multitude of serious health complications, allegedly stemming from hernia surgery in 2007. While he experienced chronic pain, professional responses to his situation ranged from dismissal to denial. From the doctors’ perspectives the hernia had not returned, thus demonstrating the success of the procedure. Yet, despite the successful nature of the surgery, in this case, the side effects outweighed the benefits. 

The responses to many questions remain contested or disputed at this time, such as:

  • Do the long-term benefits of mesh medical devices outweigh the risks (side effects)?
  • How is reasonable assurance of safety and effectiveness of mesh medical devices measured? 
  • What practices are in place (locally and globally) to ensure patient voices are listened to and acted upon?
  • What systems are in place to deter companies from favouring profit and commercial gain above the interest of patient safety?

Nevertheless what is apparent is the need to ensure patients are able to make informed decisions about their healthcare and well-being. In order to do this patients must be fully informed about the risks. Beyond this, a patient-led approach must be centred at the heart of future health care procedures and provision. The hope is that such an approach will guarantee the focus remains on patient safety first; and deters other agendas which would potentially conflict with the best interests of patients.

There are a number of mesh campaign groups throughout the UK and globally which offer general advice and support to individuals affected by mesh harms. Groups include:

This blog was originally published by the Harm and Evidence Research Collaborative at The Open University. See http://www.open.ac.uk/researchcentres/herc/blog/mesh-denial-half-truths-and-harms

Reflections on COVID-19, Prisons and Legal Activism

Dr. David Scott, The Open University and Prof. Joe Sim, Liverpool John Moores University

In April 2020, we provided expert legal evidence to a court case involving a terminally ill prisoner. To the best of our knowledge this is the only legal case to date calling for the release of a dying prisoner in the context of the elevated risks to prisoner health through the spread of COVID-19 in prisons.

Prisons are crowded and unhygienic environments which historically have been hot-beds for the spread of contagious diseases, such as tuberculosis.  Many prisons are vermin infested and in a poor state of repair. They are often also draughty, something also significant given the recent evidence of how COVID-19 can spread through the air. A number of prison cells do not meet the basic international standards and minimum rules with regards to size or conditions and some prisons, such as HMP Coldingley and HMP Long Lartin, hold prisoners in cells with no integral sanitation.

Epidemiologists and other experts, including the government’s own advisors from Public Health England, have noted that unless there was a radical reduction in the prison population, which on 21st February 2020, stood at 83,695, then there could be a humanitarian catastrophe resulting in up to 3,000 prison deaths.  Whilst government initially seemed persuaded by these arguments, any possibility of a radical reduction in prison numbers disappeared off the political agenda almost as quickly as it had arrived.  By 12th February 2021, the prison population had declined by more than 5.000 during the pandemic to 78,188 and this small and almost certainly temporary reduction in numbers is now considered sufficient by a government clinging tightly to a ‘law and order’ ideology at whose centre stands the prison.

A Dual Strategy

Since March 2020, penal policy has followed a bifurcated strategy aimed at expanding the capacity of single-cell occupancy (by around 500 places) and containing the spread of the disease through cohorting, which brings together prisoners who actually had symptoms of COVID-19; shielding, which is very similar to the notion of isolation within the broader community; and maintaining social distancing through an authoritarian lockdown which has  dramatically curtailed the already limited prisoner interactions prisoners have with each other and the wider community. This strategy, which is dehumanising and hugely harmful to prisoners’ physical and mental health, has denied them visits with their family and left them isolated in prison cells for up to 22 and a half hours a day. In a thematic study published on 11th February 2021 exploring the impact of the pandemic on prisoners, the HMCIP found incontrovertible evidence that the ‘cumulative effect’ of the prison lockdown was having a devastating impact on ‘prisoners’ emotional, psychological and physical wellbeing’.  Whilst some prisoners do have access to telephones, in-cell sanitation, showers, computer games and televisions, all too many are living in bare and austere prison cells.  One embarrassingly antiquated response of the Prison Service in an attempt to keep prisoners occupied during the lockdown has been to give them crayons and colouring in books.

It is too early to tell just how harmful this lockdown is going to be in terms of the wellbeing of prisoners, or indeed, how people are going to react once the lockdown is lifted and there is an outlet for their pent-up frustration.  What we do know is that in 2020 there were 318 deaths in prison in England and Wales and that 67 (of those currently classified) were self-inflicted deaths. In December 2020 alone, there were 24 Covid-19-related prisoner deaths and between March 2020 and January 2021, at least 86 prisoners died from the disease.  In this same 10-month period, 10,345 prisoners tested positive for Covid-19 – which is about 1 in 8 of the prison population – indicating the limited effectiveness of the current authoritarian approach.  We also know that there has been a dramatic increase in the number of self-harm incidents in women’s prisons, where according to Ministry of Justice data, during the 12 months from September 2019-September 2020 there was a reported 3,557 incidents of self-harm for every 1,000 women prisoners. It has also been recently reported that the first six months of 2020, 15,615 prisoners were put on ACCT (assessment, care in custody and teamwork) / suicide-watch plans in prisons in England and Wales, which is a significant increase on the numbers from the previous year.

Going to Court

In March 2020, we were approached by a member of the legal team representing a terminally ill prisoner in HMP Stocken who had bladder cancer.  The prisoner had a life expectancy of somewhere between three to 18 months but had been denied compassionate release under the Prison Service Order 600 and the Criminal Justice Act of 2003. The significant thing about compassionate release is that it is permanent, rather than release on a temporary licence (ROTL).

For various reasons, compassionate release was denied. His lawyers asked us to submit written evidence indicating the limitations of the existing lockdown policy and highlighting some of the difficulties that a prisoner would face in terms of living with a terminal illness in the context of COVID-19.  Our first submission drew attention to concerns raised by Her Majesty’s Chief Inspector of Prisons about the unhygienic environment in HMP Stocken, as well as evidencing broader concerns about the spread of COVID-19 in prisons across the country.  Our submission was in compliance with the broader position of the prisoner’s legal team that the current government approach to COVID-19 in prisons was presenting an existential threat to life and, more broadly, was a breach of human rights.

The Ministry of Justice’s case was that as the prisoner had perpetrated a violent crime and there was some ambiguity about how long he had to live, that he would continue to present a threat and was, therefore, a risk to public protection.  They argued that the Prison Service had made what they considered to be reasonable adjustments to existing policy to accommodate people who were terminally ill within prisons.

One of the basic rules for those giving expert evidence to the courts is that any claims made in written or verbal submissions must be fully substantiated by evidence and that the function of the expert is to help the court come to an informed decision rather than present an argument from a given political or ethical standpoint. Any claims must ‘stand up in court’ and rightly should be subjected to the greatest of scrutiny.  Yet, in their formal written response to our first submission, the state’s lawyers largely side-stepped the evidence we had marshalled and instead indicated that we might be less than credible witnesses because we were, and are, closely associated with the hugely nuanced and sophisticated theoretical and ethical perspective of abolitionism. Our submission was dismissed because we argued simply ‘against imprisonment’. This is a classic tactic pursued by the state when it has little or no answer to challenges to its authority: discredit critics, apply pejorative labels, simplify complex positions and suggest critics are biased while implying that the state’s position is exemplary and value free. It is the politics of distraction.

Operating within a very short deadline, we drafted a second submission, reiterating the evidential basis of our first submission and questioning some of the assumptions of both the prison service’s evidence and the skeleton case for the state. The government’s response was that HMP Stocken had introduced a successful shielding situation, and thus because of the reasonable adjustments made there would be no difficulties with the spread of COVID-19. This has proved to be a dangerous and inaccurate assumption.  On 18th February, according to a report in the Times, Public Health England indicated that 92 out of 117 prisons had experienced an outbreak of the virus. In the previous week, ‘an outbreak at HMP Stocken caused Rutland, England’s smallest county, to have the highest infection rate in the country with around about half of 199 new cases reported in the prison’. The local Rutland and Melton MP Alicia Kearns indicated that the number of COVID-19 infections at HMP Stocken at this time was approximately 100 prisoners.  According to the Times, ‘ten of its inmates [prisoners] ended up in intensive care in local hospitals’.

The case wended in a stalemate, when the Secretary of State’s legal team indicated that the prisoner might now be considered for release on temporary license, the ROTL.  Prior to the court hearing it had appeared that any possibility of ROTL was impossible and therefore had not been fully pursued.  The prisoner’s legal team continued to work for his release (both on ROTL and compassionate grounds) and drew upon the evidence we had submitted to strengthen their case.  In early August 2020, the prisoner was permanently released on compassionate grounds under Prison Service Order 600 and the Criminal Justice Act, the grounds that were originally pursued by the legal team.


The acceleration in COVID-19 cases in prison, and the traumatic physical and psychological impact of the lockdown on prisoners and their families, raises profound questions about the government’s strategy for protecting prisoners and ensuring their safety. It also raises profound questions about the abject failure of Ministers to grasp a unique opportunity to begin the process of radical decarceration, removing people from prison and investing in well-funded, well-staffed alternatives to custody. However, this government, like its Conservative, Coalition and Labour predecessors, remains welded to an iron, law and order ideology which, despite all of the evidence to the contrary, unconditionally supports the misplaced idea that the prison acts as a bulwark against crime – or at least crimes committed by the poor and the powerless as the systemic criminality of the powerful, and the harms they generate, remain protected by an unapologetic culture of immunity and impunity. Jeffrey Reiman and Paul Leighton’s powerful assertion that ‘the rich get richer and the poor get prison’ remains as true now in the middle of a pandemic as it ever was. The corrosive failure to develop radical alternatives to the prison is not simply a political choice but represents a moral failure of the highest degree. To detain dying prisoners inside until literally their last breathe is shameful. However, asking government Ministers to feel ashamed is like asking not only for the moon but for every star in the universe. Such a move requires a degree of self-awareness and humanity which the inhumane logic of neoliberalism, and the starkly degrading policies and practices of state institutions, neither encourage nor support. That is the brutal reality for prisoners, and their families, in this pandemic.

This blog was published simultaneously by the Harm and Evidence Research Collaborative at The Open University and the Centre for Criminalisation and Social Exclusion, Liverpool John Moores University. See: https://oucriminology.wordpress.com/

Primodos: The Next Steps Towards Justice

Sharon Hartles, Member of the Harm and Evidence Research Collaborative, The Open University

Wednesday 8th July 2020, marked the publication of the final report by the Independent Medicines and Medical Devices Safety Review, which was commissioned to examine the harmful effects of three treatments: Primodos, an oral hormone pregnancy test that caused birth defects;  sodium valproate , an epilepsy drug that also causes birth defects, and surgical mesh, a treatment for incontinence that causes chronic debilitating pain. Primodos was the most widely prescribed ‘hormone pregnancy test’ in the UK (and around the world) in the 1960s and 1970s until it was taken off the market in 1978.  First Do No Harm found that avoidable harm was caused because the UK Government and the Healthcare system failed in their duty to protect patients and regulate Primodos.

Source: https://twitter.com/IMMDSReview/status/1035530830792273920/photo/1

For the Primodos-affected members of the Association for Children Damaged by Hormone Pregnancy Tests, a lobby group, the findings and recommendations offered recognition ‘that hundreds of families have been wronged.’ Recommendation 1 of First Do No Harm was fulfilled when Matt Hancock apologised for the avoidable harm caused to those who suffered. However, after this welcomed and prompt first step towards justice, the next steps – the implementation of the remaining eight recommendations – have been fraught with resistance. 

Baroness Julia Cumberlege, a life peer who chaired the Independent Medicines and Medical Devices Safety Review, explicitly championed the need for the recommendations set out in First Do No Harm to be implemented with determination and urgency. Despite this, it has now been more than three months since the report was published, which may not seem like much time within the political agenda, and given the preoccupations with Covid and Brexit, but England is lagging behind Scotland. At a 9th July 2020, press conference, Julia Cumberlege raised concerns about the importance of implementing the report’s recommendations and the significance of not leaving it to “sit on a shelf and gather dust”. 

Yet, two months later, amid rumours the report was going to be buried, during a Parliamentary debate which took place on 2nd September 2020, the Baroness requested assurances from Ministers that the recommendations would be implemented. On the same date, MP and chair of the All-Party Parliamentary Group on Hormone Pregnancy Tests, Yasmin Qureshi, took a different approach. Namely, she accused Government Ministers of hiding behind irrelevant “legal action, which has no bearing on this report’s findings” to ignore their duty to implement First Do No Harm recommendations a point which she had previously voiced in a letter to Matt Hancock on 15th July 2020.

To its credit the Scottish Government has led the way; and on 1st September 2020, First Scottish Minister Nicola Sturgeon confirmed that Holyrood had accepted, in full, the recommendations of Baroness Cumberlege and would be appointing a Scottish Patient Safety Commissioner, “the emphasis of this new role is on the patient voice within the safety system.”  Moreover, on 13th September 2020, Andrew Davies, Shadow Minister for Health announced that a Welsh Conservative-led government would appoint ‘an independent patient safety commissioner in Wales.’ Currently, First Minister of Wales and the Welsh Labour-led government Mark Drakeford has not made any announcements regarding intentions towards the appointment of an Independent Patient Safety Commissioner.  

The Independent Medicines and Medical Devices Safety Review findings have had wider reaching ramifications. Primodos, a drug marketed by the West German pharmaceutical company Schering AG, was marketed in West Germany until 1981 as Duogynon. On 16th September 2020 the German Federal Ministry of Health announced it would be launching a review into whether or not the relationship between the regulator then the Federal Health Office today known as the Federal Institute for Drugs and Medical Devices  and the manufacturer then Schering AG, now Bayer AG led to ‘the drug remaining on the market despite concerns about its safety.’ 

In an article by Jason Farrell, Home Editor at Sky News, published on 19th September 2020, he noted ‘The German government has been reluctant to look into the issue and campaigners in Germany were relying on a breakthrough in the UK. That came after an independent review in Britain found in July that government health regulators had failed patients and that Primodos was responsible for “avoidable harm”.’ Although Jens Spahn German Federal Minster for Health, confirmed a research project into possible collusions between the German regulatory authority and the manufacturer; he also made it clear that “all the known findings and the scientific evidence do not currently support a causal link” between the hormone pregnancy test and birth defects.

Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, met with the German Health Committee and MPs in March 2019 to present analyses from Oxford University scientists Carl Heneghan and Jeffrey Aronson. Based on the research conclusions she discussed a possible review of Primodos and Duogynon and its association with ‘increased risks of congenital malformations.’ The subsequent pressure from German politicians calling for a review, together with First Do No Harm findings played an instrumental part in sparking the German investigation into the Duogynon scandal. For Marie Lyon, who has been working with the Duogynon Network, an association for members affected by Duogynon, since 2012, the announcement came as “a huge step forward for the German campaign group and one we thought we would never see happen”.

Image: Courtesy of Sharon Hartles (adaption/remix of  I , IIIIIIV , VVI, VII ) MPs supporting calls forthe implementation of First Do No Harm recommendations. (From left to right – Sir Ed Davey, Leader of the Liberal Democrats, Ian Blackford, Westminster Leader of the SNP, Sir Jeffrey Donaldson, Leader of DUP Party in Westminster, Caroline Lucas, co-Leader of the Green Party, Liz Saville-Roberts, Plaid Cymru, Westminster Leader, Colum Eastwood,  Leader of the Social Democratic and Labour Party and Sir Keir Starmer, Leader of the Labour Party).

Back in the UK, in a bid to ensure that First Do No Harm is not ignored on 16th October 2020, six leaders of political parties: Sir Ed Davey, Ian Blackford, Sir Jeffrey Donaldson, Caroline Lucas, Liz Saville-Roberts and Colum Eastwood signed a joint letter to Prime Minister Boris Johnson urging him to ‘instruct the Department of Health to implement the findings of the Cumberlege Review’. According to the All-Party Parliamentary Group on Hormone Pregnancy Tests on 28th October 2020, Sir Keir Starmer added his signature of support, a notable action, because all seven opposition party leaders have presented a united front in calling on Boris Johnson to implement the Independent Medicines and Medical Devices Safety Review recommendations “in full and without delay.”

The UK government failed in its duty to regulate Primodos. The health care system failed in its duty to protect patients.  These failures resulted in avoidable harms spanning decades. For Primodos survivors these alleged life changing harms include: cardiac malformations, musculoskeletal, neurological, neurogenetical malformations, miscarriage and stillbirth. However, it was not the role of the Independent Medicines and Medical Devices Safety Review to determine whether or not there was ‘a causal association between HPT use and physical malformations’. Therefore the review findings have not laid to rest scientific debate around the contested harmful nature of this synthetic sex hormone. And so there are still open questions regarding claims about the effects caused. What is significant, is that Recommendation 4 of First Do No Harm states ‘The state and manufacturers have a moral responsibility to provide ex gratia payments to those who have experienced avoidable damage from the interventions we have reviewed.’  First Do No Harm may not have determined a causal association but recommendation 4 suggests that the Independent Medicines and Medical Devices Safety Review findings are a long way from establishing harmlessness.

Source: https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf

Now is not the time for the Government to unnecessarily prolong further suffering. It is time for these survivors of Primodos (and of sodium valproate and surgical mesh) to get the recognition and justice they so rightly deserve. In line with Recommendation 2, the appointment of an Independent Patient Safety Commissioner who will champion the patients’ voices and perspectives is long overdue. Furthermore, in accordance with Recommendation 9, action must be taken immediately to set up a task force in order to schedule a timetable for the implementation of the remaining recommendations as set out on 8th July 2020 by First Do No Harm.

To find out 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 a number of ways you can support the campaign:

– Follow ACDHPT on Twitter
– Follow ACDHPT on Facebook
– Sign ACDHPT’s petition Protect patients and make our healthcare system safer for your children to Prime Minister Boris Johnson calling for him to implement the recommendations set out in the Cumberlege Review
– Encourage your MP to join the APPG for hormone pregnancy tests
– Make a donation to help ACDHPT continue their campaign
– Get in touch with Marie Lyon

This blog was originally published by the Harm and Evidence Research Collaborative at The Open University. See: http://www.open.ac.uk/researchcentres/herc/blog/primodos-next-steps-towards-justice

Primodos: The first step towards Justice

Sharon Hartles

Primodos was the most widely used hormone pregnancy test prescribed to women in the UK. During 1958 to 1970 Primodos was marketed as a hormone pregnancy test and for the treatment of secondary amenorrhea. However, this was changed to just the treatment of secondary amenorrhea from 1970 to 1978, at which stage Primodos was withdrawn from the UK market. When Primodos was placed on the UK market in 1958 there was no centralised structured pharmaceutical regulation. In other words, no licence was required, no specific safety test was needed and there was no general consumer protection legislation.

In 1978, the Association for Children Damaged by Hormone Pregnancy Tests, was set up in the UK to represent families who suffered congenital abnormalities, stillbirths and miscarriages, allegedly due to taking the oral hormone pregnancy test Primodos. Decades of fighting for justice to uncover the truth about the failures of past Government Health Regulatory Authorities led to a review being commissioned in February 2018, by Jeremy Hunt, the then, Secretary of State.

The announcement in the House of Commons was for a review into how the health system responds to reports about harmful side effects from medicines. This stemmed from patient-led activist campaigns on the use of: hormone pregnancy test Primodos, sodium valproate and surgical mesh. Jeremy Hunt stated “patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many.”

Two and a half years after this review was commissioned, on Wednesday 8th July 2020, the Independent Medicines and Medical Devices Safety Review published the First Do No Harm Report. This Report, together with the additional supporting documents to accompany it including: Personal Testimonies, Oral Hearing Transcripts, Hormone Pregnancy Tests Supporting Information, Timeline Key Events, History of Regulation and the Press Conference Speech (by Baroness Julia Cumberledge, CBE, Chair of the Independent Medicines and Medical Devices Safety Review) evidence unequivocal systemic failures and a clear link between PRIMODOS and its tragic side-effects.


Source: Sky News

Marie Lyon, Chair of the Association for Children Damaged by Hormone Pregnancy Tests and active campaigner for justice, since 1978, on reading the First Do No Harm Report, declared “I’ve tried to be very calm and I can’t. It’s the fact it’s been acknowledged. They’ve actually looked at the documentation honestly and openly and for me that is the biggest result for our families today. They will be absolutely overjoyed.”

The Independent Medicines and Medical Devices Safety Review has set out nine recommendations in their First Do No Harm Report. Recommendation 1: states ‘The Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.’ On the 8th July (the date the report was published) Matt Hancock, Secretary of State for Health and Social Care apologised “on behalf of the NHS and the whole healthcare system” to those who have suffered and their families.

For decades, there have been numerous publications evidencing an association between hormone pregnancy tests and congenital malformations in babies. In 2018 and 2019, Oxford University published an analysis of data which found a clear association relating to Primodos and birth defects. Other supporting research which have found links between hormone pregnancy tests and birth defects includes:

However, there have also been opposing publications which have found no association and/or inconclusive results. In 2017, the Medicines and Healthcare products Regulatory Agency (MHRA) published their report on the use of hormone pregnancy tests and adverse effects related to pregnancy including possible birth defects. The MHRA is an independent Expert Working Group of the UK’s commission on Human Medicines, which was established, in October 2015, in order to conduct this review. The MHRA found there to be insufficient evidence to support an association. Other opposing research includes:

For Marie Lyon, Chair of the Association for Children Damaged by Hormone Pregnancy Tests “after viewing the oral evidence presented by members of the Expert Working Group who were responsible for the scientific publication in 2017, it seems I already have a perfect example of the denial and protection culture endemic in our regulators. Denial when problems occur and protection, not for the patient but for the manufacturer.”

In light of the decades of jostling to and fro of supporting and opposing evidence, it is clearer to understand why the findings of the Independent Medicines and Medical Devices Safety Review in the First Do No Harm Report, together with Matt Hancock’s prompt apology on behalf of the UK Government and acceptance may in the first instance offer some form of relief for the families of the Association for Children Damaged by Hormone Pregnancy Tests.


In the Press Conference Speech by Baroness Julia Cumberledge Chair of the Independent Medicines and Medical Devices Safety Review, she stated ‘In our view Primodos continued to be given as a pregnancy test for years longer than it should. In the face of growing concerns it should have ceased to be available from 1967.’ Yet Primodos remained on the UK market until 1978. This is a failure on behalf of the UK Government to protect its population from harm. Equally, a failure on behalf of the corporation Bayer (Schering). Primodos, was manufactured by Schering in Germany. In 2006 Schering was acquired by Bayer plc.

It is important to point out that Amenorone Forte a hormone pregnancy test prescribed by GPs, during this same time frame, acted in much the same way as Primodos and was manufactured by Roussel in France.  Roussel was acquired by Sanofi in 2004. For this reason families of the Association for Children Damaged by Hormone Pregnancy Tests hold both corporations accountable for the avoidable harm inflicted.

According to the Independent Medicines and Medical Devices Safety Review, History of Regulation, The Medicines Act 1968 received Royal Assent in October 1968, however the ‘transitional period’ meant this Act did not come into effect until 1st September 1971. During this time the Committee on Safety of Drugs was formed, yet it had no legal powers. With little irony, there was no formal regulator, it was part of a voluntary arrangement. There was no body to legally mandate the removal of a drug from the market and limited mechanisms to regulate drugs and restrict their use.

More systemic failures followed because the Committee on Safety of Medicines, (which replaced the Committee on Safety of Drugs, 1st September 1971) focused its gaze on formalising new medicines entering the UK market. Products, including Primodos, which had been on the market before the 1st September 1971 were automatically granted a Product Licences of Right (PLR).

Primodos was awarded a PLR yet its product which had been on the market since 1958, had never been required to submit evidence of quality, safety or efficacy. This oversight to ensure Primodos met the appropriate standards of safety, quality and performance in line with new rules was another missed opportunity to protect public health and safeguard the interests of patients and users.

The Independent Medicines and Medical Devices Safety Review Timeline has brought to light other damning evidence. On 22nd July 1969 Schering UK wrote to Schering Germany recommending the removal of the pregnancy testing indication. In a letter dated 17th February 1970 to Schering, Dr Ruttle a member of the Standing Committee on the Classification of Proprietary Preparations (known as the MacGregor Committee – 1965 and 1971) which provided guidance as to which preparations should be used on the NHS, stated ‘The Committee would be prepared to place the product in A.3 if the promotional indication as a “pregnancy test” were withdrawn and I would suggest that the most appropriate and, acceptable to the Committee, promotion be “symptomatic treatment of amenorrhea to produce withdrawal bleeding.”

On the 9th March 1970 Schering agreed ‘to the deletion of “pregnancy test” from the indications, and to the promotional statement “the symptomatic treatment of amenorrhea not due to pregnancy, by producing withdrawal bleeding”. Further correspondence in April 1970 acknowledged the suggestions from Schering (removing the pregnancy test indication and altering promotional statements) and confirmed that Primodos would be placed in category A.3 (prescription-only medicines).

Five years later, the Committee on Safety of Medicines (an independent advisory committee to the UK medicines licencing authority) published a letter in the British Medical Journal (BMJ) on 26th April 1975. In this letter the Committee on Safety of Medicines stated they agreed with an article published five months earlier in the BMJ entitled Synthetic Sex Hormones and Infants which advised ‘there is little justification for the continued use of withdrawal type pregnancy tests when alternative methods are available.’

On 5th June 1975, the Committee on Safety of Medicines sent an alert letter – to all doctors in the UK – entitled Hormonal Pregnancy Tests, in which they advised them of a possible association between hormonal pregnancy tests and an increased incidence of congenital abnormalities. The Committee on Safety of Medicines stated ‘In view of the possible hazard, doctors should not normally prescribe certain hormonal preparations for pregnancy tests’.

Spanning 1958 to 1978, Primodos was given to around 1.5million women in Britain. Primodos was a hormone pregnancy test prescribed to women to detect pregnancy. It consisted of two tablets which were to be taken on consecutive days. A negative pregnancy test would result in a withdrawal bleed (within three to ten days of consumption of the tablets). It is now known that Primodos prescribed to women to confirm their pregnancy, by today’s standards equates to 13 morning-after pills or 40 oral contraceptive pills. Moreover, the hormones contained in Primodos are now used in the morning-after contraception pill.

A statement taken from the Independent Medicines and Medical Devices Safety Review Personal Testimonies from the families of the Association for Children Damaged by Hormone Pregnancy Tests illustrate their distress – “We feel that we were used as collateral damage by the pharmaceutical company who were developing the contraceptive drug at the time.” The personal testimonies of Nicky Gibbins and Daniel Mason evidence how “The effect on our lives have, as you can imagine, been devastating.” The alleged impacts of PRIMODOS comprise:

  • all congenital malformations
  • more specific malformations:
    • cardiac malformations
    • musculoskeletal
    • neurological
    • neurogenetical malformations
  • birth defects
  • miscarriage
  • stillbirth


The First Do No Harm Report together with the supporting documents is significant because it evidences a clear link between Primodos and the terrible avoidable harms that have been perpetuated for decades through a culture of denial and the absence of state and corporate accountability.

Acknowledgement in the form of an apology on behalf of the Government was the first step towards justice. However, in a letter dated 13th December 2018, to the Independent Medicines and Medical Devices Safety Review, Bayer stated ‘there is nobody at Bayer plc who could usefully contribute anything on the subject matter of your inquiry’. Notwithstanding this response, it is now time to look to the future.

The Government (on behalf of the UK regulators) and corporations Bayer (Schering) and Sanofi (Roussel) should as recommended in the First Do No Harm Report, fund the costs of care for those affected by state and corporate harm. In addition to this, the families of the Association for Children Damaged by Hormone Pregnancy Tests using the Independent Medicines and Medical Devices Safety Review evidence should be able to successfully take legal action for the harms done to them by Bayer, Sanofi and the regulators.

n line with recommendation 9, of the First Do No Harm Report, the Government has a duty to set up a task force which must schedule a timeline for the implementation of the remainder of the recommendations. Such initiatives should endeavour to provide a safety net to ensure that a patient-led approach is centred at the heart of future health care provision.

This blog was published simultaneously by the Harm and Evidence Research Collaborative at The Open University.
See: https://oucriminology.wordpress.com/