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Primodos: The first step towards Justice

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[/vc_column][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”3/4″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][/vc_column][/vc_row][vc_row type=”in_container” full_screen_row_position=”middle” column_margin=”default” scene_position=”center” text_color=”dark” text_align=”left” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none”][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text]HERC: In this article, Sharon Hartles reflects upon the significant impacts of avoidable harms that have been perpetuated for decades through a culture of denial and an absence of state and corporate pharmaceutical accountability. Sharon Hartles was awarded an MA in Crime and Justice (with distinction) from The Open University in December 2019 and is a member of HERC.

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However, this was changed to just the treatment of secondary amenorrhea from 1970 to 1978, at which stage Primodos was withdrawn from the UK market.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.

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.”

 

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Hannah Bardell seeks justice for Primodos families

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[/vc_column][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”3/4″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][/vc_column][/vc_row][vc_row type=”in_container” full_screen_row_position=”middle” column_margin=”default” scene_position=”center” text_color=”dark” text_align=”left” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none”][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text]DAILY RECORD: SNP politician Hannah Bardell wants the Government to implement the findings of a damning report into health scandals, including the pregnancy test drug.

Hannah Bardell said mothers were treated like “guinea pigs” and “mocked” when they raised concerns about the drug, which was given to women from 1958 until it was taken off the market in 1978.

Mums who used it believe it caused abnormalities in babies, including shortened limbs, heart defects, brain injuries and stillbirths.

The report into families affected by Primodos, sodium valproate and pelvic mesh, published earlier this month, concluded patients came to “avoidable harm” because the healthcare system failed to act when serious concerns were raised.

Baroness Cumberlege, a former Tory health minister, who led the review, called for an urgent shake-up to rid the NHS of an “arrogant and dismissive culture”, which resulted in many doctors writing off patients’ crippling symptoms as “women’s problems”.

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Baroness Cumberlege’s Speech

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The following is the speech given by Baroness Cumberlege on 8th July 2020.

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Good morning.

  1. The people of Britain have every reason to be proud of their NHS.Its response to the pandemic has demonstrated the exceptional care and bravery of staff, but this does not mean that the healthcare system is free from faults.
  2. We have reviewed three interventions which have caused avoidable harm to thousands of people. We revealed how the healthcare system in its entirety does not work for some patients. If this Government and the Healthcare system ignores our Review, and another intervention damages people at such a scale, the Government and the Healthcare System will not and should not be forgiven.
  3. We have called our report “First Do No Harm”. Why?Because it is a well known phrase. Those working in healthcare recognise it as the starting point for good quality care. That should be not only for doctors but for the whole of the system.Too often we believe it has not.
  4. Jeremy Hunt, then the Secretary of State, commissioned our Review and asked us to look at three medical interventions.
  5. Sodium valproate, an effective medication for epilepsy. But still today this medication causes harm to unborn children when their mother, unaware of the risks, takes it when she is pregnant.Pelvic mesh, used to treat pelvic organ prolapse and urinary incontinence. Many women have suffered terrible complications following their mesh surgery.Primodos, a hormone pregnancy test taken by women between the 1950s and the late 1970s, associated with damage to children, and those children now adults, are still needing care and support
  6. At the start of the Review – 2 and a half years ago, – we realised we had to find out first- hand from women and their families, what impact these medications and devices had, had on them.
  7. Travelling across the UK we met over 700 women and their families. They made a lasting impression on us.

Their experiences were harrowing. They told us of lives that had been damaged, families under immense strain, relationships destroyed, careers broken, and as a result financial ruin, with no income , , many lost their homes, and faced their children being taken into care.

They spoke of the most intimate details not only about their lives, but about their bodies.

They spoke with such dignity and courage. Above all I want to thank them.

  1. Women told us that when pregnant and controlling their epilepsy with Sodium Valproate, they were never told that their unborn baby could be seriously damaged. They did not know that the chances were one in two – one in two damaged babies – what a tragedy.
  2. We met women who told us that they were given two little pills called Primodos to confirm whether they were pregnant. Many went on to lose their babies or to give birth to babies who were damaged. Now in their 70s parents still carry the guilt that taking these two pills may have caused this irreparable loss or harm. They agonise as to who will care for theirdisabled offspring when they no longer can.’
  3. We met women whose lives have been turned upside down by mesh. Many were healthy and active but they were offered a quick fix for their incontinence or prolapse. An operation they thought would cure them has ruined their lives. They have lost their independence, their careers, life partners, sex life, even their ability to go for a walk. Their relentless physical pain is like razors inside their body. They feel helpless, alone, and ignored. Some have suicidal thoughts.
  4. Among those we met, and many more who contacted us by email and phone we heard common themes. These themes arose from patients’ experiences and they are in Chapter 2 of our report. I urge you to read them.
  5. I and members of the Review team have conducted many reviews and we all agree – we have never encountered anything like this, the intensity of suffering, the fact that it has lasted for decades. And the sheer scale. This is not a story of a few isolated incidents. No one knows the exact numbers affected by mesh, Primodos and sodium valproate but it is in the thousands. Tens of thousands.
  6. As if the physical, developmental and emotional harm weren’t enough, these families have had to fight to be listened to and to be taken seriously.
  7. They organised themselves into groups and have battled for years. I want to thank the patient groups. Their expertise, courage and tenacity is truly remarkable and they have helped us throughout. I want to stress our Review was set up because these people refused to give up.
  8. In our research we have been astonished how the healthcare system–which includes the NHS, private providers, the regulators and professional bodies, manufacturers, and policymakers– is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its sole purpose. It has failed to listen to their concerns.
  1. Over the past two years we have found ourselves in the position of recommending, encouraging and urging the system to take action that should have been taken long ago.
  2. Innovation in medical care has done wonderful things and saved many lives. But innovation without pre-market testing, post-marketing surveillance and long-term monitoring is quite simply dangerous.
  3. The fact is that the healthcare system does not know the scale of the problems we were asked to investigate. It is flying blind.
  4. The healthcare system fails to acknowledge when things go wrong. it fears blame and litigation – mistakes are perpetuated through a culture of denial, a resistance to no-blame learning, and an absence of accountability.
  5. There are times when manufacturers fail to acknowledge that their product is causing harm. They fail to recognise their obligation to contribute towards help for patient who have suffered harm.
  6. In the face of all this we have found that patients are exposed to risks when they do not need to be.
  7. I now want to briefly explain our conclusions on each of the three interventions we looked at.

Primodos

23. 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. A non-invasive alternative was available by then, and the concerns that were being expressed should have led to action by the regulator. It continued to be given to women for years longer. While there is disagreement between experts about whether Primodos caused birth defects, the fact remains that thousands of women and unborn children were exposed to a risk that was acknowledged at the time. That should not have happened. This is not a case of us judging the actions of the past by the standards of today. This was discussed at the time, but not acted upon. The system failed.

Sodium valproate

  1. Sodium valproate has been licensed in the UK since 1972. It was known from the very beginning that it is harmful to unborn children. No one disputes that.Yet, even today, hundreds of women who are taking valproate become pregnant without being aware of the risks.
  2. These women and their children have been let down by the healthcare system. Health professionals do not inform them of the risks, regulators have not done enough to make them do so, and no one is tracing those affected. There is simply a woeful lack of support and help.

Pelvic mesh

  1. Women with mesh complications have suffered terribly. We were so appalled by this suffering that in July 2018 we said that mesh for the treatment of Stress Urinary Incontinence must be halted immediately. We set conditions that had to be met before these operations could continue. Today, two years later, they have not been met.
  2. Twenty years after mesh started to be used in the pelvis we still don’t know its long-term risks or complication rate. The same is true for mesh removals.There is still no consensus on how to treat these complications and what type of procedures are best.
  3. We have said that if the conditions for lifting the pause are ever met and the pause is lifted, then mesh should only be considered after all the other surgical and non-surgical options have been considered. And women must be able to make a fully informed decision about a mesh implant in the full knowledge of all the risks.
  4. On this basis, we expect that the number of pelvic mesh procedures in the future will be tiny. Gone are the days when women in their tens of thousands had mesh implanted and were told it was the gold standard.
  5. I want to conclude by summarising the nine major recommendations we are making. Taken together, these recommendations are wide ranging and radical.
  6. The system’s response – or lack of it – has added to people’s suffering and pain. It needs to acknowledge what has gone so badly wrong.
  7. So our first recommendation is that the Government must immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
  8. Next the patient voice needs to be strengthened. Patients know when something has gone wrong. Their experience must no longer be ignored.
  9. We don’t need another re-organisation of the NHS. We don’t need another regulatory bodyBut we do need a new voice, with statutory powers, to encourage the system to do what needs to be done.We need a person of standing who sits outside the healthcare system and who is accountable to Parliament through the Health and Social Care Select Committee.
  10. So our second recommendation is that a Patient Safety Commissioner is appointed. This person will be the patients’ port of call, the listener, the advocate, who holds the system to account, monitors trends, and above all demands action.

This is the golden thread, tying the disjointed system
together in the interests of those who matter most. The patients.

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.

  1. We are therefore recommending that separate schemes should be set up for Hormone Pregnancy Tests, valproate and pelvic mesh to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.Patients have waited far too long for redress. These schemes must be set up at speed.
  2. Beyond these three specific schemes – for the future, we need a new way of dealing with redress, a way to resolve disputes between patients and the healthcare system. It is not right that the only option for people who have been harmed is to attempt to go to court.
  3. So our fourth recommendation is the establishment of a Redress Agency. Rather than blaming individuals, its decisions will be based on whether there has been avoidable harm. The support it provides should be both non-monetary and financial.
  4. The costs of running the Redress Agency should be met by contributions from manufacturers and the state, but it must be situated outside the current organisations and it must be independent.
  5. Those who have been harmed deserve better care and support. We are therefore recommending the establishment of two types of specialist centres – one for mesh, and another for those affected by medications taken during pregnancy. They will be located regionally. As well as meeting clinical needs, these centres should act as a one stop shop, able to signpost and refer patients to other services.
  6. A regulator must work both for patients and with them. This hasn’t been the case in the past. We are recommending that the regulator of medicines and medical devices, the MHRA, is overhauled. It needs to change and radically improve the way that concerns about medicines and devices are detected and acted upon. The regulation of devices in particular needs urgent change. The MHRA needs to engage more with patients and track how medicines and devices improve – or fail to improve – patients’ health and quality of life. It needs to raise public awareness of its role and it needs to ensure that patients have a core role in its work.
  7. Earlier on I described the system as flying blind – every successful organisation knows that good data is essential. Detecting concerns over medical devices, tracking patient outcomes and acting swiftly to prevent harm, is impossible without good data. Currently no one knows the number of patients implanted with pelvic mesh, their surgeon, the mesh product used, or the outcomes.
  8. We are recommending that a central database should collect these details, including retrospective details. We asked the Secretary of State to make the collection of this information mandatory and he has agreed. The database will be linked to registries to research and audit outcomes in terms of both device safety and the patient’s experience.
  1. There is no central register of clinicians’ financial and non-
    financial interests. We are concerned by doctors who have financial and other links with manufacturers
  2. So our 8th recommendation is that the register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors. The public has a right to know.
  3. Likewise, manufacturers must should report payments made to teaching hospitals, research institutions and individual clinicians under a new law similar to the similar to the Physician Payments Sunshine Act in the US.
  4. We hope this Government, and all those bodies that comprise the healthcare system, will take heed of what we have to say, and that our recommendations will be implemented with determination and urgency.That leads me to our final recommendation which is about implementation. We want the Government to immediately set up a task force to implement this Review’s recommendations. Its first task should be a timeline for implementation.
  5. Innovation and technology will bring exciting change. There is potential to do so much good, but we must ensure the risks of increasingly complex healthcare are understood – where the system is not sure of the risks it must say so. Had it done so in the case of our three interventions, I have no doubt that much anguish, suffering and many ruined lives could have been avoided.
  6. Our recommendations will improve the lives of people who have been harmed and make the system safer in the future. This report must not be left on a shelf to gather dust. Implementation needs to be approached with a new urgency and determination, founded on the guiding principle that our healthcare system ……must ……..first ……do no harm.

Thank you.

 

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Primodos scandal: ‘Significant’ changes were made to key report

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SKY NEWS: A Sky News investigation raises questions about the validity of a 2017 study which underwent “significant changes”.

An inquiry on Wednesday ruled that many of the children born to mothers who used the drug suffered “avoidable harm”.

But now a freedom of information (FOI) request has raised questions about the validity of a previous study conducted by the regulator which was less favourable to the victims.

Campaigners who used Primodos as a pregnancy test believe the hormone-packed pill could cause miscarriage or congenital malformations to babies in the womb, from heart defects to spinal problems or shortened limbs.

On Thursday, health minister Nadine Dorries told the Commons: “I would like to make an apology to those people on behalf of the health and care sector for the time the system took to respond.”

It came after the Cumberlege Review said there is now a “moral duty” for the manufacturer of Primodos to contribute to a fund to care for those allegedly damaged by the drug.

However, the drug’s manufacturer, Schering, was taken over by Bayer in 2006, and the German pharmaceutical company disagrees with the review team.

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:: Listen to the podcast: Primodos, mesh and valproate scandals – what next for survivors? on Apple Podcasts, Google Podcasts, Spotify, Spreaker

 

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What was the birth defect scandal linked to the drug?

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[/vc_column][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”3/4″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][/vc_column][/vc_row][vc_row type=”in_container” full_screen_row_position=”middle” column_margin=”default” scene_position=”center” text_color=”dark” text_align=”left” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none”][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text]THE SUN: DRUG SCANDAL What is Primodos and what was the birth defect scandal linked to the drug?

The oral hormone-based pregnancy test Primodos was given to women in the UK in the 1960s and 1970s by their GPs.

Now, parents claiming their babies were affected by the drug have said they’re preparing to sue its makers and the Government.


Primodos was a hormone-based medication given to pregnant women to detect pregnancy between 1958 and 1978.

What is Primodos and what is it used for?

Primodos was a hormone-based medication given to pregnant women to detect pregnancy between 1958 and 1978.

Around 1.5million women in Britain were given Primodos.

It consisted of two pills that contained high levels of synthetic progestin and oestrogen hormones.

Those hormones would be later used in the morning after pill.

What was the Primodos pregnancy test drug?

Primodos maker Schering instructed women to “take one tablet on each of two consecutive days.

It said: “Bleeding follows in three to six (rarely as long as ten) days, if there is no pregnancy.

“An existing pregnancy is unaffected by Primodos.”

It was removed from the market in 1977 after concerns were raised but they were not proven.

In 1978, Primodos was discontinued after doctors noticed an increase in the number of deformed babies born to mothers who had been on the drug.

Primodos was manufactured by the drug company Schering, now part of Bayer, which continues to deny it caused deformities in children.

What birth defects has Primodos allegedly caused and how have people suffered?

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Damning report exposes three health scandals

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[/vc_column][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”3/4″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][/vc_column][/vc_row][vc_row type=”in_container” full_screen_row_position=”middle” column_margin=”default” scene_position=”center” text_color=”dark” text_align=”left” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none”][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text]DAILY MAIL: If we only ever sanctify the NHS, its harrowing failures will NEVER be cured, says IAN BIRRELL as a damning report exposes three health scandals

By IAN BIRRELL FOR THE DAILY MAIL

Daniel Mason was born half a century ago without hands, with missing toes, a malformed mouth and impaired vision.

From an early age, he — and his family — had to deal with people asking about his disabilities. The impact on his life has been considerable.

His car, clothes and eating implements must be tailored to his needs. He has not been able to form intimate relationships. Not surprisingly, he has suffered bouts of depression.

We must accept that everyone, even doctors and nurses, can make errors. And it would be far kinder to distressed families not to drag out legal battles for years, writes Ian Birrell (file photo)

Daniel’s mother Daphne long suspected the cause of his problems was a powerful hormone tablet called Primodos that was given to women to determine whether they were pregnant. But when she raised her concerns with doctors, they were dismissed.

Now, at last, Daphne has been vindicated with official confirmation this week that her fears were right, in a 277-page landmark review by Baroness Cumberlege into three separate health scandals that has exposed a litany of shameful failings by the NHS, regulatory authorities and private hospitals.

 

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Healthcare system ‘unresponsive and defensive’ over safety concerns – review

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[/vc_column][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”3/4″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][/vc_column][/vc_row][vc_row type=”in_container” full_screen_row_position=”middle” column_margin=”default” scene_position=”center” text_color=”dark” text_align=”left” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none”][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text]THE MAIL: “Harrowing” stories of pain and suffering have been laid bare in a report which concludes that patients came to “avoidable harm” because the healthcare system failed to respond in a speedy and appropriate way when serious concerns were raised about some medical treatments.

By Press Assc. 8th July 2020

A scathing inquiry into three NHS scandals sets out how patients were “dismissed” and “overlooked”.

The healthcare system has a “glacial” and “defensive” response to concerns over treatments, the inquiry found.

The review examined how the health service responded to concerns over pelvic mesh – which has been linked to crippling, life-changing complications including chronic pain, infections and loss of sex life; the anti-epilepsy drug sodium valproate – which has been linked to physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy; and hormone pregnancy tests such as Primodos – which are thought to be associated with birth defects and miscarriages.

The system “does not know” how many women have been affected by these scandals, the reviewers said.

They detailed “heart-wrenching stories” of how treatments provided on the NHS had “damaged lives” and highlighted how campaigners have fought for decades to “achieve acknowledgement” of their suffering.

“We met with hundreds of affected patients and their families … it became all too clear that those who have been affected have been dismissed, overlooked, and ignored for far too long. The issue here is not one of a single or a few rogue medical practitioners, or differences in regional practice. It is system-wide,” the review states.

More than 700 families from across the UK affected by the issues gave “harrowing details of their damaged lives”, which Baroness Cumberlege, chairwoman of the review, described as “heart-wrenching stories of acute suffering, families fractured, children harmed and much else”.

 

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‘I trusted my doctors’: the women fighting for justice after medical procedures

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[/vc_column][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”3/4″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][/vc_column][/vc_row][vc_row type=”in_container” full_screen_row_position=”middle” column_margin=”default” scene_position=”center” text_color=”dark” text_align=”left” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none”][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text]THE GUARDIAN: An inquiry into the harmful effects of medical treatments prescribed to female patients in England has highlighted a series of scandals

By The Guardian. 8th July 2020

Jacqueline Ciseau, 64, was 17 when she became pregnant in 1973. Her doctor recommended a hormone pregnancy test, which confirmed she was expecting a baby. She had a straightforward pregnancy and delivery, but when her daughter was two or three years old, Ciseau became concerned as she hadn’t started speaking or reached other developmental milestones. Ciseau went back and forth between doctors but never got a clear explanation for her daughter’s disability.

She mentioned the hormone pregnancy test, but said that doctors dismissed this as a possible explanation. “The way they treated us was appalling,” she said.

It was only in the 1980s, when she read an article in the Manchester Evening News about Primodos that she felt convinced there was a connection. “Primodos is 40 times the strength of the contraceptive pill,” she said. “You don’t have to be a genius to think that if you give that to a pregnant woman, it’s not going to do the foetus any good.”

However, despite safety concerns around Primodos dating from the 1960s that eventually led to its withdrawal as a pregnancy test, the manufacturer Bayer Pharma (formerly Schering) has consistently denied that there is evidence the tests caused abnormalities in children. “Still today we do not have an answer, we are still struggling to get justice,” said Ciseau. “We’ve been fighting for 50 years. I’m 64 and my husband is 73. I want justice, so our daughter can be looked after when we are no longer around. It’s our daughter who is the victim.”

 

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A historical argument for regulatory failure in the case of Primodos and other hormone pregnancy tests

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REPRODUCTIVE BIOMEDICINE & SOCIETY ONLINE
[/vc_column][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”3/4″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][/vc_column][/vc_row][vc_row type=”in_container” full_screen_row_position=”middle” column_margin=”default” scene_position=”center” text_color=”dark” text_align=”left” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none”][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text]REPRODUCTIVE BIOMEDICINE & SOCIETY ONLINE: Article by Jesse Olszynko-Gryn, Eira Bjørvik, Merle Weßel, Solveig Jülich, Cyrille Jean

Abstract

The drug Primodos and other hormone pregnancy tests (HPTs) remained on the British market for about a decade after they were first implicated, in 1967, as a possible cause of birth defects. In November 2017, an expert working group (EWG) set up by the Medicines and Healthcare Products Regulatory Agency (MHRA) concluded against such an association. However, it was explicitly ‘not within the remit of the EWG to make formal conclusions or recommendations on the historical system or regulatory failures’, a situation that has left many stakeholders dissatisfied. Placing the question of a teratogenicity to one side, this article takes a more contextual and comparative approach than was possible under the auspices of MHRA. It asks why an unnecessary and possibly even harmful drug was allowed to remain on the British market when a reliable and perfectly safe alternative existed: urine tests for pregnancy. Based on archival research in several countries, this article builds a historical argument for regulatory failure in the case of HPTs. It concludes that the independent review which campaigners are calling for would have the potential to not only bring them a form of closure, but would also shed light on pressing issues of more general significance regarding risk, regulation and communication between policy makers, medical experts and patients.

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