Time For Action respond to the Cumberlege Patient Safety Report, ‘First Do No Harm’

The Independent Medicines and Medical Devices Safety Review report, informally known as the Cumberlege Patient Safety Report, was published this week. It is as compelling as it is compassionate; forthright in its evaluation of fundamental and overarching weaknesses within the health and regulatory systems when faced with safety issues and in its conclusions and recommendations. The review team has done what it suggests health care professionals and the regulators should do – listen and hear patients’ personal experiences of harms caused by medicines and devices.  As a result, the review is an accurate reflection of our own experiences when our children became ill after having the HVP vaccination – enduring 10 years of insurmountable hurdles to get the recognition, help and support they deserve.

Time for Action applauds the wide-ranging strategies and practical steps to begin to remedy where the healthcare stakeholders fall well short to prevent the failings of inaction following concerns over safety. 

‘The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that.’ Baroness Cumberlege

The report highlights the substantial changes that are necessary to restore public trust as well as ensure safety within the healthcare system, not least a fundamental overhaul for the regulators – with a ‘new legal framework’ to ensure prompt action on detection of possible harms.

The Time For Action patient advocacy group lobbied tirelessly to be included in the review as we felt that we had very similar grievances to the three medicines and devices investigated; unfortunately the government did not extend its remit beyond these but stated that the findings from this inquiry would benefit us all in the future. 

‘…the hope is that other patient groups will also benefit from the outcomes of the Review.’ DHSC 28/6/2018

We certainly hope this is the case because the IMMDSR has drawn up comprehensive and detailed recommendations that have the potential to make a positive impact – not only for Time for Action’s children but patients from the other groups who submitted evidence but were omitted from the scope of the inquiry.

Recommendations that Time for Action wholeheartedly welcome

  • A fully independent Patient Safety Commissioner to hold together the ‘disjointed system’ – ‘patients’ port of call, listener and advocate, who holds the system to account’ –  something sorely missing and necessary to ensure patients come first.
  • A new independent Redress Agency for those harmed by medicines or devices – ‘ Adverse events reports would be centralised…to help regulators detect signals earlier.’

    We would also like to see vaccine damage covered by the Redress Agency and not by a separate Vaccine Damage Payment Unit, which is part of the DWP, as it is virtually impossible to make a successful claim.
  • A ‘substantial revision’ of the regulatory body – the MHRA –‘… reform with legislation, views of the patients listened to and experiences used to inform licencing and regulatory decisions”

    Robust post marketing surveillance – in the case of vaccinations, the relatively small number of people involved in clinical trials means that the true picture of rare, serious harms only comes to light once the vaccine is used in the population.  But if the systems in place to identify these adverse reactions are poor, e.g. the Yellow Card reporting system, if patients are being dismissed and not listened to by clinicians, as repeatedly highlighted in this report, then suspicions of the dangers are not picked up quickly, if at all.

    It is the opinion of Time for Action that post marketing surveillance for all products needs to be done separately from the MHRA and licensing of drugs/devices.
  • A central registry/database – ‘…patient-identifiable registries for new devices and medicines that can be interrogated over time to assure long-term efficiency and detect harm.’
  • Transparency of payments to clinicians, research institutes and teaching hospitals – to ensure conflicts of interests do not get in the way of patient safety

    Conflicts of interest, incomplete research, biased conclusions result in inaccurate safety outcomes of pre-marketing clinical trials for products – impacts negatively on government decision making by  masking harms, makes informed consent a nonsense and impacts on the regulators’ perception of the products’ safety:

‘…research that is funded by manufacturers that never sees the light of day because it is negative or inconclusive…or is less than transparent in its declaration of conflicts of interest when positive findings are reported.’ IMMDSR page 8

Recommendations that would be beneficial if extended to patients suffering adversely following HPV vaccination

  • Networks of Specialist centres for ‘comprehensive treatment, care and advice’ would be a game-changer for our children. Time for Action believe a registry for potentially HPV vaccine damaged patients would be ideal in understanding the wide-ranging and poorly documented symptoms, leading to effective and more prompt treatments in the future and ultimately pin-pointing those individuals who are predisposed to adverse reactions to vaccines – to mitigate the harms. Also, the illnesses are complex – often multi-system, can result in rare neurological or autoimmune symptoms which require specialist help that is often difficult to access in different parts of the country. (For example, a temporal association with the HPV vaccination and dysautonomia/POTS and ME/CFS has been identified in several published journal papers, but the few paediatric POTS clinics have been closed in recent years making diagnosis nearly impossible, and the few paediatric ME/CFS services that exist are usually led by clinical psychologists.)
  • A registry specifically for recipients of HPV vaccination would capture more complex information about serious adverse events which is difficult on the Yellow Card system of reporting, especially for the multi-system, fluctuating and changing symptoms experienced. 

    A HPV vaccine registry should look at the health outcomes of all vaccinated patients, to include HPV typing of cervical cancers and also record other incidence of cancer (with HPV type if relevant), pregnancy outcomes etc. as well as recording adverse events.

What next?

Baroness Cumberlege and the review team have given us a promising glimpse of what should happen next – we will endeavour, along with the other patient groups, to ensure this becomes a reality. 

To further the scope of the review’s implementation and outcomes, we would like to be involved in patient discussions with the new independent Patient Safety Commissioner once appointed and to ensure processes put in place will adequately include other current and future patient groups.

We would also like to continue discussions with the MHRA and be a part of their on-going improvements with safety surveillance and pharmacovigilance, ensuring ‘that patients have an integral role in its work’.

Time for Action sincerely hopes that these sorely needed/necessary changes, identified by the review, will be implemented and incorporated fully into our world-class healthcare system and that it brings about a fundamental shift in attitude.  The difference these recommendations will have on the future of healthcare will be immeasurable if undertaken rigorously and changes sustained.  Progress in medicines go hand in hand with safety – recognising and acting upon these unintentional harms swiftly, effectively, openly and sympathetically.

Time for Action is currently reviewing the report in detail and will issue a more detailed response in due course.