The long-awaited Cumberlege review, which shines a much-needed light on women’s health, suffering and medical treatment, has been published. It reveals how women’s lives have been ruined by three key health scandals: The hormone pregnancy test Primidos, epilepsy and bipolar drug, Sodium valproate, and pelvic mesh implants.
Baroness Cumberlege, who led the review, heard how women were shamed into being called “hysterical”. The pain, suffering and enduring agony they experienced was ignored. And then when they did make complaints, these were simply trivialised as “women’s problems”.
Thanking the NHS for rising to the “enormous challenge” of the Covid-19 pandemic and applauding them for “their amazing commitment”, Baroness Julia Cumberlege, Chair of the Independent Medicines and Medical Devices Safety Review warned that the report made for “uncomfortable reading, including for the hard-working, compassionate people who do excellent work in our health service.”
“I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of suffering experienced by so many families, and the fact that they have endured it for decades. Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself,” Baroness Cumberlege stressed.
Medicines and Medical Devices
The Review was asked to investigate what had happened in regards to two medications and one medical device:
Hormone pregnancy tests
Hormone pregnancy tests such as Primodos, which were removed from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages. “‘I can honestly say that my heart is broken at the outcome of those two tablets given to me by my doctor” – patient testimony from a mother who used an HPT. The system does not know, so neither does the review, how many women took a Hormone Pregnancy Test, such as Primodos, between the 1950s and 1978 when it was withdrawn. Nor does it know how many miscarriages may have occurred after taking this medication, how many of the children born to mothers who took Primodos may have suffered physical malformations or died before reaching adulthood, or how many of those children, now adults, may still be alive and in need of extensive care and support.
An effective anti-epileptic drug, Sodium valproate causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy. “We weep for the child who could have been and the man who never was” – Parents of those affected by sodium valproate exposure during pregnancy. The system does not know, so neither does the review, how many women over four decades took sodium valproate. Or who then went on to become pregnant because they had not been properly informed as to the risk they were taking and the options open to them.
Pelvic Mesh Implants
Pelvic mesh implants, which are used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence. Its use has been linked to crippling, life-changing complications. “This device took everything from me my health my life my job my dignity my marriage my freedom. There are a lot of us suffering” – A mesh-affected patient. The system does not know, so neither does the review, just how many women have been treated for stress urinary incontinence and the repair of pelvic organ prolapse using polypropylene mesh. The system does not know, so neither does the review, just how many women have been treated for stress urinary incontinence and the repair of pelvic organ prolapse using polypropylene mesh.
The report of the Independent Medicines and Medical Devices Safety Review, entitled First Do No Harm, was called so as it is familiar to those working in healthcare as the starting point for good quality care. It is an ethos, a benchmark, a guiding principle that should not only be so for doctors but for the whole of the system. Yet, “too often we believe it has not”, Baroness Cumberlege reveals in her report.
During its research, which involved 16 drop-in events and meeting over 700 affected individuals and families, the review identified numerous common themes experienced by people:
- the lack of information to make informed choices;
- lack of awareness of who to complain to and how to report adverse events;
- the struggle to be heard;
- not being believed;
- dismissive and unhelpful attitudes on the part of some clinicians;
- a sense of abandonment;
- life-changing consequences, not only for those directly affected but for their families and friends too;
- breakdown of family life;
- loss of jobs, financial support and sometimes housing;
- loss of identity and self-worth;
- a persistent feeling of guilt;
- children becoming their mothers’ and siblings’ carers;
- clinicians untutored in the skills they need to make a proper diagnosis;
- clinicians not knowing how to learn from patients;
- inaccurate or altered patient records;
- a lack of interest in, and an inability to deliver, the monitoring of adverse outcomes and long-term follow-up across the healthcare system.
Highlighting in her speech how “this report must not be left on a shelf to gather dust”, Baroness Cumberlege issued nine key recommendations that should be adopted. And that we owe tremendous gratitude and whole-hearted support to the women and families who have spoken with such “dignity and courage” and whose “experiences were harrowing”:
- 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.
- Appoint a Patient Safety Commissioner, who will be an independent public leader. This person will be the patients’ port of call, the listener, the advocate, who holds the system to account, monitors trends, and demands action to seek improvements to patient safety around medicines and medical devices.
- A new independent Redress Agency should be set up. Rather than blaming individuals, its decisions should be based on whether there has been avoidable harm. The support it provides should be both non-monetary and financial.
- Separate schemes should be set up for each intervention: Hormone Pregnancy Tests, Sodium valproate and pelvic mesh. These will be established to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.
- Networks of two types of specialist centres should be established: one for comprehensive treatment, care and advice for people affected by implanted mesh, and the second for those adversely affected by medicines taken during pregnancy. They will be located regionally. As well as meeting clinical needs, these centres should be able to signpost and refer patients to other services.
- The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medicines and medical devices, needs to be 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 ensures that patients have a core role in its work.
- A central patient-identifiable database should collect these details, including those that are retrospective. The review team asked the Secretary of State to make the collection of this information mandatory and he agreed. The database will be linked to registries to research and audit outcomes in terms of both device safety and the patient’s experience.
- Improvements need to be made to the transparency of payments made to clinicians. 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.
- The Government should immediately set up a task force to implement the review’s recommendations. Its first task should be a timeline for implementation.
“Our recommendations will improve the lives of people who have been harmed and make the system safer in the future,” urges Baroness Cumberlege. “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,” she emphasises.
“It has taken this Review to shine a light on systemic failings,” the review says. After ‘first do no harm’, comes ‘next, do some good’. “It can and must do both,” the review adds.
As we’re fighting feverishly for reform, it forces the medical sphere to ask what are perhaps uncomfortable questions: Is women’s pain still not being taken seriously? Are women being misdiagnosed? Is women’s health less valuable and valued than men’s?
But why are they uncomfortable? They shouldn’t be. Transparency should be welcomed, advocated for, celebrated. This disparity must stop. Our pain must be important to our society. Our health, our happiness and our lives must be valued and listened to.
Describing the healthcare system as disjointed, siloed, unresponsive and defensive, “the system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns”. And “listening to patients is pivotal to that”, stresses Baroness Cumberlege.
You can read the report in full here.