Are lessons ever learnt?
HART have previously reported on recent failings of the MHRA. Here, the acknowledgement of those failings by politicians is contrasted with their continued praise of the MHRA with respect to covid vaccines.
In 2018, the then Health Secretary Jeremy Hunt commissioned the Independent Medicines and Medical Devices Safety Review. Its purpose was to investigate harms caused by two pregnancy drugs and one device. Primodos, Sodium Valproate and Vaginal Mesh Implants. When he announced it, he promised, “better information for pregnant women and their families; better training and support for obstetricians; better evidence around dosing recommendations; making electronic yellow card reporting available directly to clinicians and patients at the point of care and stronger and more joined up messages on safety.”
In July 2020, (4 months prior to Pfizer Covid vaccine approval) the damning review findings were published and presented to Matt Hancock with nine major recommendations. The review called for a major overhaul of the UK health services including the NHS and MHRA along with the adverse events reporting systems and better monitoring of conflicts of interest.
When Baroness Cumberledge spoke about her work in 2019 she said,
“We have more evidence to hear before we write our report. But there are some emerging themes. The lack of proper warning about risks; the lack of informed consent; a system whose first inclination is to deny that there is a problem or simply to ignore concerns; where concerns are eventually heard, the sluggishness of a proper response, the dismissiveness and the arrogance of some (and I stress only some) in the medical profession; the byzantine complexity of a regulatory system that few within it seem to fully understand let alone patients and the public; the fight for diagnosis and support when things have gone wrong and the inadequate resources available.
Most troubling to me is that these issues have come to our attention not by regulators, doctors, the NHS but by people power. People affected have organised themselves into campaign groups and with the help of members of parliament pushed the issue up the agenda until finally someone takes notice. My Lords, that tells me there is something seriously wrong- a system that is not working as it should. People who have been harmed should not have to fight to be heard or to access the care that they need. ”
Her report was published in July 2020 and called for “overhauling adverse event reporting” and an “overhaul of the culture in the MHRA…to ensure that the patient perspective and the public interest always takes precedence over the interests of industry.“ It said, “Patients must be central to the workings of the MHRA” and that “the MHRA should be subject to binding timescales for decisions on risk management.” One concluding recommendation was for a Patient Safety Commissioner, “with statutory powers, to talk and act from the perspective of the patient, to encourage the system to do what needs to be done and hold it to account.”
Matt Hancock made an apology in July 2020. “This report is a wake up call to the system to respond to patient’s concerns and take very seriously concerns from people who are suffering. One of the most striking things I found… [was] the deep frustration that nobody in authority in the system would listen to them. We have to listened to them and this report details those painful accounts that voice has been heard now and we need to take action.”
In November 2020, only four months later, Hancock’s views on our regulators and health services sounded completely different to the scandal he’d described in July 2020. He said, “The MHRA is one of the world’s most respected regulators.” The same compromised regulators who’d caused such harm for so long and then ignored and gaslighted victims, were now suddenly bastions of independence, preceded by a world class reputation.
A year after the Cumberledge report, the Department of Health and Social Care, then under Sajid Javid, wrote a response. It said, “The government fully accepts the overarching conclusion that the system failed to listen to patients, or to put patients at the centre of their care..We have accepted the majority of the Report’s 9 strategic recommendations and 50 Actions for Improvement.” At the time we were 8 months into the vaccine rollout.
In 2022 the MHRA published the below update on its major reform policies. For a supposedly ‘world class’ organisation it seems odd they require such sweeping changes. This was happening in the middle of the mass vaccination campaign.
In the report they refer to themselves as an “enabling regulator” putting this adjective before any mention of safety. Dame June Raine, the head of the MHRA had previously described her plan to change the MHRA from “watchdog to enabler.” The report’s section on patient safety fails to acknowledge the need to improve their ability to listen to patients.
The story here is clear.
While publicly telling us to trust the regulators and health services to deliver safe and effective vaccines, the same ministers were in agreement behind the scenes that these institutions were in fact completely untrustworthy.
The receipts on this timeline prove that they were lying to the public about the credibility of the MHRA. Meanwhile, they were simultaneously agreeing that the organisation required significant reform based on unprecedented patient safety failings.
