Cumberlege review exposes stubborn and dangerous flaws in healthcare

On 8 July the Conservative peer Julia Cumberlege published her much anticipated Independent Medicines and Medical Devices Safety Review, looking into the response of England’s healthcare system to patients’ reports of harm from drugs and medical devices. Commissioned in 2018, the review was conducted through the lens of three medical treatments: hormone pregnancy tests (mainly the drug Primodos), alleged to cause serious birth defects; the anti-epileptic sodium valproate, which can cause birth defects and developmental delays; and pelvic mesh, a surgical material (technically a medical device) implanted in thousands of women to treat organ prolapse and urinary incontinence. Mesh is now the subject of intense global scrutiny after reports of serious long term effects from material that has twisted, moved, disintegrated, or caused severe allergic reactions.

The Cumberlege review was inspired by longstanding patient campaigns alleging harm from these three interventions, and the panel’s explicitly declared approach was that patients’ and families’ voices, experiences, and views should be “at the heart of the review.” The published report lives up to that promise. The review panel spoke to over 700 affected individuals, held oral hearings, and received evidence from manufacturers, clinicians, and other stakeholders. They documented pervasive shortcomings in the marketing and oversight of the three treatments and in the response to patients who raised concerns. They considered their findings generalisable across healthcare, as the cover letter states: “We have found that the healthcare system—in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers—is disjointed, siloed, unresponsive, and defensive. It does not adequately recognise that patients are its raison d’être.”1

Hormone pregnancy tests, sodium valproate, and pelvic mesh have been the subject of regulatory action in the UK and elsewhere. The tests were withdrawn in 1979, 11 years after concerns first emerged.2 Sodium valproate, now also used as a psychiatric medication, is the subject of warnings and voluntary restrictions for women of childbearing age, although, as the report documents, it is surprisingly difficult to get this critical information to either patients or doctors.34 Mesh for pelvic organ prolapse has been the subject of international campaigns and has recently been withdrawn or advised against in most higher income countries. The mesh bladder sling for urinary incontinence, while “paused” in England, remains available in most other countries.5678 The review found that action in all three cases has been sluggish and inattentive to concerns raised by patients.

Perhaps most striking was the testimony from hundreds of patients reporting lack of informed consent for their initial treatment, followed by years of dismissal by clinicians and regulators who did not want to associate life altering symptoms or injured children with their medical interventions. In a press release Cumberlege said that in years of reviews and inquiries she had never encountered anything like the intensity of suffering of these medically injured families.9 The review panel found that healthcare providers’ dismissive attitude toward patients was underpinned by a reluctance in all parts of the system to collect evidence on potential harms, by a lack of coordination that would allow clinicians and agencies to interpret and act on that information, and by a culture of denial that failed to acknowledge harm and error, impeding learning and safety.