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  • Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies

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    Summary

    In this opinion piece, Kath Sansom, Founder of the Sling the Mesh Campaign, argues that the UK regulatory systems for medicines and healthcare have not been fit for purpose for a number of years. Framed within the context of the Cumberlege Review, Kath uses evidence and personal insight to highlight flaws in the system, and to make the case for urgent reform. 

    Content

    Falling asleep at the wheel causing a multiple car crash is considered such a serious offence in law that the driver could face up to 14 years in prison.[1]

    When it comes to falling asleep at the medical regulation wheel, however, causing major harm to patients, the result appears to be a review, knuckles rapped, a few negative media reports and then business as usual.

    Campaigners celebrated when Baroness Cumberlege called for urgent reform of the way healthcare treatments are regulated in her First Do No Harm Report.[2]

    But really, this is old news.

    As long ago as 2005, the Government called for reform of the Medicine and Health Regulatory Agency (MHRA), after finding it complacent and incompetent. The review uncovered a worrying level of Influence from industry.[3] [4] [5]

    Sixteen years later, in 2021, however, it’s the same story, similar platitudes. Disasters like mesh, valproate and Primodos, must never happen again.

    But didn’t we hear this after the metal hip and PIP breast implant tragedies?

    To ignore overhauling the MHRA for a second time would be irresponsible at best. Criminal at worst and lead to health disasters ad infinitum. A relentless ground hog day of people queuing in the wings, waiting to take spotlight on the human disaster stage.

    The MHRA is the UK body that’s supposed to check that the drugs we take, and the implants put into our bodies, are safe. All too often, though, patient reports of harm are not listened to or are dismissed as subjective, unscientific and anecdotal.[6]

    Regulation is so disjointed it’s beyond a joke. Reports of harm are made to different bodies at different times, so identifying and responding to adverse trends is difficult. Especially if those receiving the reports have limited requirements to communicate with each other, let alone work cooperatively.

    Baroness Cumberlege asked regulators and arms lengths bodies including the MHRA, if they could explain how this had happened. “They could not assist us,” she said.[7]

    In its evidence to the review, campaign group Sling The Mesh said:

    “The MHRA has been too close to the industry… underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff…[we] have little faith in the ability of medical institutions that are responsible for patient safety to be open and transparent over patient safety failings.”

    So how should this gargantuan mess be fixed?

    In 2005, the Government listed 48 recommendations to the MRHA,[8]  and in 2020 the First Do No Harm report added powerful calls to action to improve patient safety.

    Below are 20 crucial points, drawn from these and my own insights:

    1. Make it a legal requirement for NHS and private doctors to report adverse events.

    At the moment it’s voluntary. Industry is mandated to report, but only clinicians at the coal face know how drugs and devices are faring. The current system is designed to fail.

    To prove the seismic malfunction, let’s look to the mesh tragedy.

    A study found that only a third of surgeons reported mesh complications.[9] In one year alone, (2008), there were more than 1,000 women readmitted to hospital suffering early mesh sling complications.[10] Yet when the MHRA published almost a decade’s worth of mesh complications their records showed just 291 by comparison. Where had all the missing women gone?[11]

    In its evidence to the Cumberlege review, the MHRA said:

    “We agree there is under-reporting of adverse events to MHRA. Our written and oral evidence illustrates the work we are doing to improve this and how this data is considered, along with many different data sources, to monitor and act fast when a safety concern emerges.”

    Is this Unicorn theory? Campaigners deserve an update on what specific measures the MHRA has put in place. We have no idea what they are.

    2. A proper awareness campaign of the Yellow Card system

    Before becoming a patient advocate, I’d only heard this term on the football pitch.

    3. The responsibility for representing industry interests should move into the remit of the Department of Trade and Industry

    This would free up the Department of Health to concentrate solely on healthcare regulation and health promotion. Entwining the two is fatal.

    4. Keep a closer eye on ‘me too’ treatments

    Mesh and many other devices are approved on a piggy-back system called Equivalence. It means if there’s something similar on the market its approved without clinical trials. Patients are the human guinea pigs.

    5. Patients must be allowed to engage with the MHRA in a meaningful way in the pre and post market approval process

    It is currently mostly industry commentating.

    6. Patient warnings must come sooner

    The MHRA should be modelled on the American MAUDE database system[12] with transparent reporting by public and clinicians and a trigger warning system when trends of harm are spotted.

    7. Implantable devices need a barcode track and trace system to help spot trends

    8. A new improved MHRA database should link up with international recalls and product warnings

    It’s crazy that one country can consider a product safe for use when another does not.

    9. When trends are spotted there should be immediate notices to hospitals to update their Information For Use leaflets (IFUs)

    10. All MHRA licensing decisions should be made public

    11. Coroner court cases should look at contributory factors and not just conclusions to see if, for example, mesh played a part

    This information should be linked to the MHRA database.

    12. Pre and post market approval must be standard for permanently implanted devices

    13. Databases should be standard for permanently implanted devices

    Consideration should be given to comparable databases for specific medications, especially those taken during pregnancy. A new prototype registry is being built to log outcomes from pelvic floor surgery. It is hoped this will act as a forerunner to databases for other permanently implanted devices in the future, and linked to the Yellow Card system.

    14. Stop the revolving door culture

    There must be a cooling off period before a person can jump from industry to a senior regulatory role in the MHRA, otherwise they’re simply marking their own homework.[13]

    Approximately 11% of staff in the medical devices division of the MHRA were previously employed in industry.[14] [15]

    15. Look at new funding models [16]

    The activities of the MHRA are currently funded primarily through the pharmaceutical industry on the medicines side, and 95% through the Department of Health and Social Care on devices. Additional funds for clinical trials and inspections of notified bodies come mostly from the Department of Health and Social Care.

    16. Act on Duty of Candour breaches

    Doctors have a professional duty of candour to be honest with patients if things go wrong. Failure to comply is a criminal offence However, the Professional Standards Authority (PSA) report that the regulators are not identifying duty of candour breaches or considering them as part of fitness to practise panels.

    17. When a safety issue is raised the MHRA should work to binding timescales on risk management, set according to the degree of public health urgency, as they are by the EU framework

    The MHRA should publish performance data and inform the Patient Safety Commissioner of non-compliance.

    18. The regulation of medicines and medical devices has been governed by EU laws since the UK joined in 1973

    Brexit means a new legal framework will be required for the MHRA. Cumberlege says we have “a unique opportunity to shape the UK regulatory agenda using what we heard and learnt throughout this review.”

    19. The MHRA only maintains a list of lowest risk devices like bandages and non-electric wheelchairs and not medium to higher risk devices like pacemakers and mesh

    This is a function of current EU device regulatory structure. The MHRA may only find out a device is being used in the UK if there’s a problem. A register of devices similar to the Australian Register[17]  should be created and maintained by the MHRA. This will make it possible to know which devices are (or were) on the UK market at any given time. Entry on the register should be a condition for selling in the UK, with the MHRA able to de-register devices and remove from sale if necessary.

    20. Prompt, co-ordinated response by the healthcare system to safety issues

    This calls for a system-wide intelligence unit to aid early signal detection, drawing on various sources of information, pharmacovigilance and issues raised by the Patient Safety Commissioner.

    Final thoughts

    In short, campaigners believe the MHRA has become a system of passive regulation that, by its own admission, becomes even more lax when it comes to medical implants / devices. In 2014 the MHRA carried out an internal investigation which says “we must take devices as seriously as medicines”, but admits resources for the devices division “have been diminishing over the years due to austerity measures”. The PIP breast scandal and mesh were tragedies waiting to happen.[18]  

    Further reading:

    Women are duped into believing the most common mesh operation is safe, campaigners say

    Medicines and Healthcare Products Regulatory Agency: Summaries of the Safety/Adverse Effects of Vaginal Tapes/Slings/Meshes for Stress Urinary Incontinence and Prolapse

    References

    1. RAC, Driving offences and their punishments (2019) 
    2. The Independent Medicines and Medical Devices Safety Review, First Do No Harm, (2020).
    3. House of Commons Health Committee, The Influence of the Pharmaceutical Industry Fourth Report of Session 2004–05; 2005:Vol 1:2005
    4. Select Committee on Health Minutes of Evidence, (October 2004)
    5. Collier J. New arrangements for the Medicines and Healthcare products Regulatory Agency. BMJ. 2005;330(7497):917
    6. The Independent Medicines and Medical Devices Safety Review, First Do No Harm 2020
    7. The Independent Medicines and Medical Devices Safety Review, First Do No Harm 2020
    8. House of Commons Health Committee, The Influence of the Pharmaceutical Industry Fourth Report of Session 2004–05; 2005;Vol 1:p114
    9. Duckett J, Morley R, Monga A et al. Mesh removal after vaginal surgery: what happens in the UK? International Urogynecology Journal 2017;Vol. 28(7):989-992 
    10. RCOG, Hospital Episode Statistics as a source of information on safety and quality in gynaecology to support revalidation 2012; p22:table 3.4
    11. MHRA, A summary of the evidence on the benefits and risks of vaginal mesh; 2014:p29
    12. US Food and Drug Administration, MAUDE - Manufacturer and User Facility Device Experience
    13. The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 2020
    14. UK Government, John Wilkinson OBE, Director of Devices to retire; 2019
    15. UK Government, Dr Ian Hudson biography 
    16. The Independent Medicines and Medical Devices Safety Review, First Do No Harm (2.60)
    17. Australian Government Department of Health, Database of Adverse Event Notifications (DAEN) 2018
    18. Stephenson, T. Expert Clinical Advice – MHRA Medical Devices Report of the independent review on MHRA access to clinical advice and engagement with the clinical community in relation to medical devices; p1-5
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