ON Thursday January 16, Conservative MP Esther McVey led a backbench debate in the Commons criticising our drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
She highlighted the MHRA’s historical failings in investigating harmful drugs, its abysmal record regulating covid vaccines, its lack of transparency, fatal conflicts of interest, its failed Yellow Card early warning system and its intimidation of journalists.
She then lambasted the organisation, established in 2003, for ignoring covid vaccine safety signals which she said caused unnecessary injury and death, and for taking four years to publish minutes from a meeting with the Commission on Human Medicines (CHM) that discussed covid vaccine benefits versus risk. ‘Full of redactions’, it left readers with ‘more questions than answers’. The MHRA had removed the CHM minutes from its website by the weekend. One can only hope to reinstate the redactions.
In July 2020, Baroness Cumberlege published a report, led by the Independent Medicines and Medical Devices Safety Review (IMMDS), into the MHRA which described the organisation as ‘disjointed, siloed, unresponsive, and defensive’. Nothing has changed, as highlighted in this important debate. The good news is that the House recognised ‘that the Medicines and Healthcare Products Regulatory Agency continues to need substantial reform’.
The Hansard transcript stretches to 25 pages with 13,000 words, so here are the edited highlights.
ESTHER McVEY (Tatton) (Con)
This House notes that the yellow card system for reporting suspected adverse drug reactions is failing, with no process for following up on serious or fatal reactions and conflicts of interest, with 75 per cent of the MHRA’s funding being derived from industry fees. It also notes the MHRA’s delayed response to reports of myocarditis, pericarditis and vaccine-induced thrombotic thrombocytopaenia following covid-19 vaccination, despite action from regulators in other countries; and calls on the Government to fully implement the recommendations in the IMMDS Review and to acknowledge the harm done to patients and the financial burden on the healthcare system as a result of the MHRA’s widespread regulatory failures.
Alarm bells rang for many of us when, in March 2022, Dame June Raine, the chief executive of the MHRA, boasted of the agency’s transition from watchdog to enabler. Twenty years ago, the Health Committee report The Influence of the Pharmaceutical Industry found that the MHRA was unusual in being one of the few European agencies ‘funded entirely by fees derived from services to industry’.
Not much has changed since, with the MHRA continuing to gain 75 per cent of its funding from the pharmaceutical industry. In this context, the agency’s transition from watchdog to enabler does little to quell suspicions of conflicts and the implications that has for patient safety.
One of the most worrying issues is the MHRA’s mismanagement of the yellow card system. The reporting scheme should be a valuable source of information about possible harms, and act as an early warning system, but there is gross under-reporting to it. As the IMMDS’s 2020 review put it, the system is ‘too complex and too diffuse to allow early signal detection’.
Under-reporting is a big problem [only 10 per cent of reactions reported] because it makes it difficult to spot safety signals and assign causation. That then translates into unnecessary harm or death, with devastating side effects from treatment going unnoticed for years, months or even decades.
In 2021, the MHRA reacted slowly to strong signals that there was a serious problem with the AstraZeneca vaccine causing an autoimmune condition called vaccine-induced thrombotic thrombocytopenia. Denmark and other European countries suspended the vaccine for all age groups on 11 March 2021. The MHRA, by contrast, only started to restrict the vaccine in some age groups nearly two months later, on 7 May – yet there was a signal in the yellow card reports as early as 8 February. How many people were needlessly exposed to a risk?
It is worth noting what happened when the Daily Telegraph reported on the potential causal link between the AstraZeneca vaccine and blood clots in March 2021. The journalist who wrote the story received a threatening call from the MHRA warning that the Telegraph would be banned from future briefings and press notices if it did not soften the news.
The system does not work. We know from freedom of information requests that the MHRA does not have a process for investigating and following up individual yellow card reports. We know that the retrieval of follow-up information from the yellow card database still requires manual extraction and that only 54 per cent of deaths reported as possibly linked to exposure to one of the covid-19 vaccines were followed up by the MHRA. That is extremely worrying or, as Matt Hancock infamously described it in a 2021 WhatsApp message, ‘shonky’. The chief medical officer, Chris Whitty, replied to that message by saying that the system ‘needs to get better’.
In the Commission on Human Medicines meeting on 18 November 2020, the expert working group asks if Pfizer was ‘required to respond to the 36 questions asked by MHRA’. In response, the MHRA confirmed that ‘there is no formal obligation to reply’. Why is there no formal obligation to reply? Surely it is essential, when making such an important decision as to whether to allow a new vaccine to be rolled out to the nation, to have those replies. The minutes do not specify the 36 questions. Indeed, they do not appear to have been mentioned again.
I asked a written question last week to see whether, in the spirit of openness and transparency, the MHRA would publish those questions, and any answers received from Pfizer. The response was that the MHRA does not intend to publish those questions or any subsequent responses. Why not? Is this not a matter of public interest? Those issues were not resolved before the MHRA gave the green light to start the vaccination of the nation.
Particularly worrying is the issue of lymphopenia, where blood does not have enough white blood cells, [lymphocytes are white blood cells crucial to the immune system] which was reported in phase 1 of the trials and then went away – not because they fixed the problem, but because testing for the condition was not conducted in phases 2 or 3.
GRAHAM STRINGER (Blackley and Middleton South) (Lab)
One of the things we should remember is that the MHRA and the whole of the health industry are swimming in a sea of pharmaceutical sharks. Pharmaceutical companies produce some extraordinarily wonderful products that keep us safe, but they also produce huge profits, and sometimes they get their products on to the markets by telling lies, or certainly by sins of omission.
DANNY KRUGER (East Wiltshire) (Con)
The vaccines were developed at a frantic rate. The Government managed to act at great speed, largely because they bypassed Whitehall. But significant questions remain, about whether the vaccines are genuinely safe and effective.
It is right that people ask questions about the data on excess deaths and wonder if there is a connection with the vaccine. Ultimately, there is only one way to answer that question: to have the data. However, we do not have access to that data. The Government hold it and, extraordinarily, they have made it available to the pharmaceutical companies that produce the vaccines, but not to researchers – individual-level death data that shows who was dosed with what vaccines and which of them died.
The UK Health Security Agency has admitted that the data exists, but has refused to release it, almost unbelievably, because of the risk to the mental health of the relatives of the dead. That begs the question, does the data show a link between the vaccines and those deaths?
We have a genuine problem with the regulation of the medical industry and of medical products. I very much welcome the appointment of R. F. Kennedy to the role of Health Secretary in the United States. He will shake things up over there. Perhaps the Minister can be our own RFK over here and bring some genuine transparency to the health system.
SHARON HODGSON (Washington and Gateshead South) (Lab)
The MHRA needs urgent and substantial reform. One area is the need for mandatory reporting of adverse events to the yellow card by healthcare professionals. Contrary to responses I received when I asked questions on the topic in the House, which argue that the current system works, it does not. It is broken. The current voluntary system, which doctors enjoy, enabling them to choose whether to log side effects and complications to the MHRA yellow card, is simply unacceptable. This voluntary system has led to many adverse events going unreported. The system must be made mandatory, but that fix alone will not work if the data is there but is not used.
RUPERT LOWE (Great Yarmouth) (Reform)
The biggest challenge in the MHRA’s history was the covid response, and it failed. It enabled the biggest assault on civil liberties and economic prosperity in my lifetime, which was lockdown – the greatest scandal of them all. It was, quite simply, the most disgraceful period of recent history. The MHRA’s insistence on vaccines for all enabled lockdown restrictions to continue for as long as they did. It must take part responsibility for the consequences: vast NHS backlogs, mental health issues rife, soaring alcohol-related deaths, obesity booming, children’s development wrecked, long-term illnesses mounting, increased substance abuse, domestic violence on the rise, unnoticed child neglect, fathers missing the birth of their children and elderly loved ones left to rot and die alone. We were not even allowed to mourn the dead properly. The wicked list is endless.
None of it was based on any science, and certainly not the vaccination of almost the entire population – including, disgracefully, young children. This was a hideous dereliction of duty by the MHRA. It was not just children it forced the covid vaccination on, but tens of millions of people who had absolutely no need for it whatsoever.
The question is: who regulates the regulator? Who protects against regulatory capture? How did the MHRA allow politicians, celebrities and even its own agency to describe these vaccines as safe and effective, when yellow card data clearly showed it is not universally safe and certainly not universally effective?
KARIN SMYTH – Labour Minister for Secondary Care
The MHRA plays a vital role in fulfilling the Government’s health mission: balancing its responsibilities to maintain product safety and championing innovation. I will be clear about the role of an enabler. It is about enabling innovative products to reach patients without compromising patient safety and without unnecessary delay.
On supporting safety, the MHRA recognises the need constantly to seek to improve its safety monitoring systems to deliver better results for people. Recent improvements include implementing the new Safety Connect IT system, following recommendations from the Cumberlege Review. This IT system will improve the efficiency of reporting and processing of yellow card reports, much of which we have heard about today, supporting the prompt identification and assessment of new safety concerns.
