The World Council for Health (WCH) has endorsed a groundbreaking new report, titled “Safe and Effective?”, which was released on April 19, 2023. The report was produced by Perseus, a multidisciplinary team of experts specializing in fields such as medicine, pharmaceutical regulation, and safety management. This comprehensive analysis aims to bring to light the systematic ongoing failures of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) in ensuring the safety and efficacy of medicines in the country.
MHRA’s Regulatory Failures Raise Concerns
The 36-page report seeks to increase the visibility of MHRA’s regulatory failures to Parliamentarians, the media, and the general public. The document details how these shortcomings have led to the public being exposed to serious side effects from the Covid-19 vaccines, including myocarditis, clotting issues, neurological problems, and immunosuppression.
Accelerated Vaccine Approval Process Leads to Adverse Effects
Bringing a new medicine to the market usually takes around ten years. However, under immense political pressure, MHRA granted Conditional Marketing Authorization for the Covid-19 injections after less than one year of clinical trials. This accelerated process has raised concerns about the potential risks and dangers associated with approving the Covid-19 vaccines based on limited evidence.
History of Oversight and Negligence
Unfortunately, it seems that lessons have not been learned from previous incidents, such as the House of Commons Health Select Committee’s 2004 examination of the pharmaceutical industry’s influence, the late withdrawal of the Swine Flu vaccine in 2009, and the damning Cumberlege Report in 2020. Numerous published reports and warnings about the risks of MHRA approving the Covid-19 vaccines on such limited evidence have gone unheeded.
MHRA’s Promised ‘Proactive Vigilance’ Falls Short
MHRA has also failed to deliver on its promise of ‘Proactive Vigilance,’ which should have included population-level NHS data, segmented by vaccination status, to examine any links between the vaccines and reported serious side effects. Additionally, the regulator has failed to adhere to best practice safety management and governance seen in other safety-critical sectors such as nuclear, aviation, defense, and oil/gas. These shortcomings include:
- No process for investigating fatal or serious Yellow Card reports
- No independent safety audits of MHRA have been carried out, despite this being required
- A distinct lack of accountability
- No predetermined safety thresholds, in stark contrast to regulators in other industries
- Funding arrangements that involve the pharmaceutical industry, creating serious conflicts of interest
Call for Urgent Action and Overhaul of MHRA’s Processes
In light of the significant number of reported injuries associated with Covid-19 vaccines and increased deaths across all age groups, the report’s authors believe it is crucial to withdraw these products until a thorough investigation is conducted. A comprehensive independent inquiry must be launched into the MHRA’s regulatory processes and performance. The agency must undergo an overhaul of its governance and accountability processes to restore public trust.
Support for Vaccine-Injured Individuals and Bereaved Families
The harm done to the vaccine-injured and bereaved family members must be recognized. Urgent measures need to be implemented to ensure future victims are diagnosed and treated promptly and compassionately. Rapid action must be taken by the regulators to identify and reduce the risk of further injuries. Moreover, society has a responsibility to acknowledge and make reparations for the significant price that many individuals and families have paid as a result of the MHRA’s failure to fulfill their duty of care to protect the public from dangerous products.
Conclusion
The release of the “Safe and Effective?” report is a critical call to action for government officials, regulators, and the public to address the serious concerns surrounding the MHRA’s regulatory failures. As the UK Parliament and the House of Lords receive physical copies of the report prepared by Perseus, it is vital that citizens also get involved in demanding change.
UK residents can contribute by writing to their MPs, urging them to read the report and act on its findings. This collective effort will help ensure that the MHRA is held accountable for its shortcomings and that necessary reforms are implemented to restore public trust in the agency’s ability to ensure the safety and efficacy of medicines.
The “Safe and Effective?” report serves as a stark reminder of the importance of rigorous regulatory processes in the pharmaceutical industry. It is crucial that we learn from these failures and work together to create a safer and more accountable environment for the development and distribution of life-saving medicines.
The report can be downloaded here: https://perseus.org.uk/main-report
