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This shameful snub to the victims of medical harm


IT IS a matter of considerable concern that the government have snubbed a 12,000-signature petition demanding an urgent review and reform of the Medicines and Healthcare products Regulatory Agency (MHRA). 

The aim of the petition was to raise government awareness of the pressing need to turn the organisation into a fully transparent, patient-first regulator, something which the last few years has shown it patently not to be. Instead of listening, the government actually defended MHRA’s safety performance. They categorically said they will not consider any review. This clearly is not acceptable.

It comes in the face of the MHRA’s record of failure to keep patients safe that goes back decades. Evidence of their approval of harmful medicines and devices and failure to withdraw them when deaths and injuries have occurred was set out in detail in the Cumberlege reportFirst Do No Harm, which was published after the start of the pandemic in 2020 but before the covid vaccine roll-out. In her introduction, Baroness Cumberledge stated: ‘Having spent two years listening to heart-wrenching stories of acute suffering, families fractured, children harmed and much else, I and my team thought it an appropriate title. It is a phrase that should serve as a guiding principle, and the starting point, not only for doctors but for all the other component parts of our healthcare system. Too often, we believe it has not.’

Since then MHRA processes have been further and apparently permanently diluted to enable the approval of covid vaccines, resulting in many deaths and injuries, reported by their own Yellow Card system. Indeed their CEO Dame June Raine proudly announced the body’s shift of function from ‘from watchdog to enabler’.

Of particular concern has been the MHRA’s failure to discontinue the AstraZeneca vaccine and indeed to continue recommending it long after other European regulators suspended or withdrew it, despite the rising death toll. It is still  officially approved in the UK to this day, though withdrawn in practice.

This is but one of the many reasons why several patient groups have come together to write an open letter to Victoria Atkins, the Secretary of State for Health, her junior minister and their Labour counterparts to challenge the government’s response and call for reform of MHRA. Many of the signatories have been harmed by medicines or medical devices, not just the covid vaccines: for example Marie Lyon’s daughter was disabled due to the hormone pregnancy test Primodos, Julie Scott was injured by a perineal post (used during hip surgery) and Susan Morgan was harmed by vaginal mesh. 

Many covid vaccine victims have also signed, notably Anne and Richard Wright, parents of 32-year-old NHS psychologist Stephen Wright, the first person known to have been killed by the AstraZeneca covid vaccine.

Charlet Crichton,who set up the UKCV Family support group for the vaccine injured and bereaved, and has written previously in these pages on vaccine injury, has specific concerns relating to the MHRA. On behalf of her group she tried repeatedly to communicate with the agency, offering to work with them so that these concerns can be addressed. It is an offer that has never been taken up. She says: ‘Leadership in patient safety seems to be focused on saying the right things, but not actively implementing them in a compassionate and timely manner.’

Another signatory, Julie Scott,said she was advised by a hip surgeon that injury from the perineal post is ‘vastly under-reported in literature: ‘I have provided the MHRA details of numerous studies confirming the risk yet they remain unresponsive and unconcerned. A recent study confirms pudendal nerve injury following hip arthroscopy was described more than 25 years ago.’ 

The MHRA responded to her concerns regarding the right to informed consent by stating: ‘It is important to know that there is always a balance between the benefits and risks of using medical devices. All medical treatment has risks as well as benefits.’

What the MHRA in this and other cases fail to appreciate is that patients are being denied details of these known risks.

The negligence of the MHRA is underlined too by the experience of another signatory, Adrian Walker. Despite being one of the first known cases of covid vaccine injury, he has never been contacted by them for further information. Nor has his consultant. 

The letter which you can read here details a number of issues of concern and subjects for reform including conflict of interests, reform of the Yellow Card system, the need for transparency, limiting funding sources and prioritising clinical trials over the safety of new medicines.

The letter is still open for more signatures and should other people wish to show their support they can sign here

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Alex Hicks
Alex Hicks
Alex Hicks is a Procurement Director, specialising in Supply Chain Compliance. He has a wife and child and has been signing petitions since 2020, and writing them since 2021.

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