UK’s Independent Medicines & Medical Devices Safety Review
Today’s publication of the independent Cumberlege Review report which was set up to look into the use of primodos (known as the forgotten thalidomide), sodium valproate and mesh has found that the UK healthcare system (including the NHS, private providers, regulators, professional bodies, the pharmaceutical industry, manufacturers and policy makers) is ‘disjointed, unresponsive and defensive’. The ‘‘system’’ does not adequately recognise that patients are its ‘raison d’etre’. In effect, the Review has stated that the “system” is not good enough at spotting trends in practice and outcomes that give rise to safety concerns.
The UK’s Review’s recommendations which include the establishment of a Patient Safety Commissioner for those harmed by medicines and medical devices in future, the expansion of the General Medical Council register to include a list of financial interests for all doctors together with overhauling the current regulatory regime which the Review says should put patients at the heart of its activity. Some of its recommendations should seriously be considered for implementation by policy makers in this jurisdiction.
Look Back Investigation
The Review found there was a systemic failure to collect data on patient outcomes. Similarly, here there is very little data available on the true numbers of Irish women who were taking valproate since it was first licensed here in the mid 70’s while pregnant and on women who have undergone mesh implant procedures. The State should undertake a look back investigation here to ascertain in the first instance, the true numbers of people adversely affected by these medicines and devices.
Cantillons Solicitors represent a number a persons who suffer from Sodium Valproate Spectrum Disorder. In May 2018, the Joint Oireachtas Committee on Health published a report on Foetal Anti-Convulsant Syndrome/Foetal Valproate Spectrum Disorder (FVSD). It made a number of recommendations including the establishment of an independent investigation to examine the historical use of valproate medicines in Ireland and into the ongoing effects of valproate medicines. In January 2020, Stephen Donnelly, T.D. now our new Minister for Health confirmed to the Medical Independent that he was “100%” in favour of an independent inquiry on valproate.
The Cumberlege Review also explored the vaginal/pelvic mesh medical device and found that women’s complaints on severe and debilitating complications were downplayed or ignored. In November 2018, the Chief Medical Officer here reported to the then Minister for Heath, Simon Harris T.D. amid growing concerns about the frequency and severity of complications associated with use of mesh devices in the surgical treatment of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in woman in Ireland. The 61 page report made 19 recommendations, some of which were to improve the regulation of this medical device, including mandatory reporting of “serious adverse events” and mandatory registration of implants used in the treatment in POP and SUI on an National Registrar. A pause remains on the use of mesh procedures in Ireland. The HSE has since prepared an Implementation Plan for the complete set of recommendations set out in the CMO’s report. A Synthetic Mesh Devices Advisory Group was also convened by the HSE to advise on and progress all of the recommendations set out in the CMO’s report. It is unclear how many of the recommendations set out in the CMO’s report have been implemented by the HSE to date.
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