UK Medicines Regulator MHRA’s Role As Pharma “Enabler” During Pandemic Comes Under Microscope

“We feel compelled to conclude that the MHRA has indeed become an enabler for the pharmaceutical industry, with patient safety no longer being its primary concern.”

On December 2, 2020, the Medicine and Healthcare products Regulatory Agency (MHRA) — the UK’s equivalent of the FDA — became the first medicines regulator in history to approve an mRNA ‘vaccine’, granting “temporary” authorisation to the Pfizer-BioNtech injection for COVID-19, just seven months after the launch of clinical trials. The agency’s chief executive, Dr June Raine, told reporters that “no corners” had been cut in approving it, and that “the benefits outweigh any risk”. She would later say at an Oxford University event that the pandemic had catalysed the agency’s transformation, under her watch, from a watchdog to an “enabler”:

We tore up the rule book and allowed companies to immediately start juxtaposing not just sequential phases of clinical trials but overlapping, beginning the next one before the previous had been finished.

On December 31, 2021, Dr. June Raine was made a Dame Commander of the Order of the British Empire “for services to Healthcare and the Covid-19 Response.” Now, just over two years later, she is preparing to step down under a cloud of scandal. UK pharma giant AstraZeneca is facing multiple lawsuits over alleged harms caused by its COVID-19 vaccine and a cross-party group of MPs and peers is urging the Health and Social Care Select Committee to launch “a thorough, wide-ranging and long-overdue investigation into the MHRA” following allegations that it failed to sound the alarm over COVID-19 vaccine side effects.

From the Daily Mail, one of the few outlets to cover the story:

Members of the All-Party Parliamentary Group (AAPG) on Pandemic Response and Recovery said ‘there is reason to believe’ the MHRA knew about post Covid vaccine complications myocarditis and pericarditis in February 2021. However, in a letter to the Government’s Health and Social Care Committee, they said it was only several months later, in June, that the MHRA alerted the public.

Steve Brine, the health committee chairman, replied to the group’s letter by saying an inquiry into patient safety is ‘very likely’, The Telegraph reported…

The letter also highlights how despite the MHRA stating in February 2021 of plans for ‘proactive vigilance’ on Covid vaccine safety, Freedom of Information (FOI) requests revealed the regulator hasn’t performed, or requested Pfizer and Moderna to perform, studies testing the link between the jabs and myocarditis and pericarditis.

In a separate letter, sent earlier this month, the AAPG stated they had ‘serious patient safety concerns’ regarding the MHRA’s actions, or lack thereof, overall.

“Gross Under-Reporting” of Adverse Events

Signed by 25 MPs and peers, the letter features a damning critique of the MHRA’s “yellow card” adverse events reporting system which, as with the open VAERS system in the US, relies heavily on patients self-reporting the side-effects:

For decades there has been something known as the ‘Yellow Card’ system through which clinicians, and indeed patients, can report suspected adverse reactions to treatment. However it is clear that there is gross under-reporting, and our complaints systems are both too complex and too diffuse to allow early signal detection.

Under-reporting hinders the ability to detect signals and assign causation. The cost to patient safety of such an unreliable system can be measured in the needless fatalities, the considerable burden on the quality of life for survivors and a £2.2 billion strain on NHS England alone.

In the UK, patients have been involved in safety reporting since 2005, but only one in 12 patients are aware that they can report a suspected ADR. A 2006 systematic review of 27 studies found that the rate of under-reporting of adverse events was, on average, 94% and possibly as high as 98%, meaning possibly only two in every 100 ADRs were reported to the MHRA…

The need to overhaul the YCS was something Sling the Mesh highlighted in its 16 December 2022 correspondence to your Committee on the IMMDS Review after the follow-up one-off session. Point 9 asks, “Why is the MHRA refusing to make it mandatory for doctors to log complications to the Yellow Card system? An overhaul of the way adverse events are logged is a key component of Recommendation 6. So far, all the MHRA has done is a “look and feel redesign” of the Yellow Card brand. The real issue at hand is mandating logging by doctors.

Another major issue is public access to available data on vaccine harms. Last week, Dame Jennifer Margaret Harries, the chief executive of the UK Health Security Agency (UKHSA), explained to the House of Commons’ Health Select Committee how UKHSA provides COVID vaccine manufacturers with official mortality data stratified by dosage and date of the COVID vaccines, all collected and maintained at taxpayer expense. Yet the same data is withheld from the British parliament and public due to its “commercially sensitive nature”:

‼️ Unbelievable disclosure at Monday’s Health Select Committee

Dame Jenny Harries appears to CONFIRM that @UKHSA has provided Covid vaccine manufacturers with official mortality data stratified by dosage and date of the Covid vaccines. However, she then goes on to suggest that… pic.twitter.com/CpueHnjdIj

— UsForThemUK 🌟 (@UsforThemUK) March 6, 2024

Dependence on Industry Money

The most important section of the AAPG letter, in my view, concerns the glaring conflicts of interest guiding MHRA’s operations:

The 2004-5 House of Commons Health committee report The Influence of the Pharmaceutical Industry found “The MHRA was unusual in being one of few European agencies where the operation of the medicines regulatory system was funded entirely by fees derived from services to industry (drug regulatory agencies in other countries are more often only partly funded by licence fees). The MHRA’s activities are 60% funded through licensing fees paid by those seeking marketing approvals and 40% through an annual service fee, also paid by the industry” and that it “failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate.”

Almost 20 years ago, the committee cautioned that industry funding could lead the agency to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies.” It was a prescient warning, albeit one that went unheeded by successive British governments.

Back to the letter at hand:

The MHRA continues to be primarily funded by income from fees for sales of products and regulatory services: the breakdown sees 50% fees for services, 25% industry periodic fees and 25% Department funding. The fact that in March 2022, Dame June Raine, Chief Executive of the MHRA, boasted of the agency’s transition from “the watchdog to the enabler” does little to quell suspicions of conflicts and the implications for patient safety and cannot be overlooked…

We feel compelled to conclude that the MHRA has indeed become an enabler for the pharmaceutical industry, with patient safety no longer being its primary concern.

As we reported in our August 2021 article, Why Is the Gates Foundation Funding the UK’s Medicines Regulator?, it isn’t just drug makers that are lining the MHRA’s coffers; so, too, are philanthrocapitalist ventures such as the Bill and Melinda Gates Foundation, which holds substantial holdings in pharmaceutical companies and has poured billions of dollars into vaccine research, development and deployment:

[T]he Gates Foundation’s roughly $60 billion in assets include, among other things, shares and other forms of investments in some of the world’s largest pharmaceutical companies, whose products the MHRA has to regulate on a regular basis. Those companies include Sanofi, Merck, Eli Lilly and Company and Abbott Laboratories, all of which have developed or are developing covid-19 treatments and/or vaccines that are yet to receive authorisation in the UK. They also include Pfizer and its German partner BioNTech, which together have developed and marketed the most profitable vaccine in history.

This is a blatant conflict of interest. It’s also worth noting that the MHRA’s former CEO, Ian Hudson, works as a senior advisor for regulatory affairs, integrated development and global health at the Gates Foundation.

The MHRA now faces accusations that it failed to alert young adults of the heart risks posed by AstraZeneca’s adenoviral vector vaccine, even as other European countries suspended the vaccine on March 11 2021 over concerns about myocarditis and pericarditis.* As the letter documents, the MHRA did not publish safety advice until April 7, by which time 24 million people had been vaccinated in the UK “without MHRA’s pharmacovigilance system detecting a problem”. The agency did not withdraw the product for under 40s until 7 May, “after further needless deaths, such as that of BBC radio reporter Lisa Shaw who received her first dose of the AZ vaccine on 29 April.”

A Global Problem

This is presumably what Dr Raine meant by the word “enabling,” the letter caustically notes. But the MHRA is not the only Western drugs regulator that is performing such a role. In fact, industry funding of drug regulators has become the international norm, with the British Medical Journal warning in 2022 that “industry money saturates the globe’s leading regulators”. The irony is that of the six regulatory systems analysed by the BMJ, the US Food and Drug Administration is the “most well funded”, with 65% of its budget coming from industry fees:

Of the six regulators, Australia had the highest proportion of budget from industry fees (96%) and in 2020-2021 approved more than nine of every 10 drug company applications. Australia’s Therapeutic Goods Administration (TGA) firmly denies that its almost exclusive reliance on pharmaceutical industry funding is a conflict of interest (COI). In response to a query, the agency said, “All fees and charges are prescribed in our legislation. To provide transparency, the TGA fees and charges are published on the TGA website.”

But for decades academics have raised questions about the influence funding has on regulatory decisions, especially in the wake of a string of drug and device scandals—including opioids, Alzheimer’s drugs, influenza antivirals, pelvic mesh, joint prostheses, breast and contraceptive implants, cardiac stents, and pacemakers. An analysis of three decades of PDUFA in the US has shown how a reliance on industry fees is contributing to a decline in evidentiary standards, ultimately harming patients. In Australia, experts have called for a complete overhaul of the TGA’s structure and function, arguing that the agency has become too close to industry.

Sociologist Donald Light of Rowan University in New Jersey, US, who has spent decades studying drug regulation, says, “Like the FDA, the TGA was founded to be an independent institute. However, being largely funded by fees from the companies whose products it is charged to evaluate is a fundamental conflict of interest and a prime example of institutional corruption.”

During the COVID-19 pandemic new medicines, vaccines and therapeutic treatments have rolled off the line in record time, often in quantities that far outstrip demand. And they are being authorised in record time — in some cases despite scant evidence of benefits (e.g., Remdesivir) and with little knowledge (or perhaps even concern) about potential risks. As the AAPG letter concludes, “the MHRA is increasingly seeking to bring medicines to market quicker with less pre-approval data and more post-approval research being conducted,” all to be overseen by a regulator that is still predominantly funded by the companies whose products it grants regulatory approval.

 

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* AstraZeneca, of course, is not the only vaccine maker whose product has been linked to increased risk of myocarditis and pericarditis. So, too, have Moderna and Pfizer-BioNtech’s mRNA therapies, as even the CDC recently admitted, as well as Janssen’s viral vector vaccine.