Covid-19: Response and Excess Deaths
Debate between Neale Hanvey and Kieran Mullan(7 months, 3 weeks ago)
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Neale Hanvey
That was not actually the point I was making. I was making the point that any clinical trial, whether something is ruled in or ruled out, is subject to GCP guidelines, and it is up to the medical research ethics committee to sign off the protocol.
Neale Hanvey
Well, the hon. Gentleman can shake his head, but that is my experience. I worked at University College London Hospitals and the Royal Marsden, and those are the principles that we applied in such a context. I can only speak to my experience. I am not a member of the ABPI, so I cannot give him those types of data. I am talking about GCP as a general principle. If he does not believe in GCP as a general principle, that is a different discussion.
Neale Hanvey
I thank the hon. Lady for her question. I think we all understand the situation that we were in. I am not using a retrospectoscope to say that things should not have been done in the way they were done. However, they should have been conducted absolutely in accordance with GCP guidelines, and that is the fundamental crux of the matter. I am not suggesting for a moment that that was not the spirit in which the various companies entered into this, but we are talking about—
Neale Hanvey
Will the hon. Gentleman let me finish the point I am making?
I am sorry, but I have now forgotten the point I was going to make to the hon. Lady. I do not think anybody entered into this to do the wrong thing, but there are fundamental questions about how we move things forward now and whether harm was inflicted as part of the administration of these agents.
Dr Mullan
I am very grateful. I raise this because the hon. Member for North West Leicestershire (Andrew Bridgen) made a point about timelines, saying that the trial was done in eight weeks and asking how the vaccine could possibly be safe. The reason why I mentioned longitudinal studies is that a common deliberate attempt to mislead people about what went on with the vaccine is to suggest that, because the trial was done over a short period of time, it could not possibly have been done correctly. Typically, trials take a long time because it takes a long time to recruit the right number of patients and to do the work. In such a trial, the same number of patients go through it over a longer period, but that does not change the baseline data, which is based on how many patients there are. We do not typically use longitudinal studies, and that vaccine trial was done by using a lot of people in a short space of time to create the same amount of evidence.
Neale Hanvey
I thank the hon. Gentleman for that clarifying point. People I have spoken to who were involved in those clinical trials have raised serious and significant concerns about the way that their experience after the drug was administered to them, and the impact that it had on them in an acute way, was either minimised or written out of trial data. That is a serious allegation, and everyone should be interested in understanding the detail. It is certainly not what I would understand would fit within the principles of GCP, and there are serious questions about how trial studies were conducted. As the hon. Member for North West Leicestershire said, the longitudinal element of that was impossible—we are now seeing that—but that does not mean we can ignore it, absolutely not. The principles I have been outlining are there because they are the basis on which good science is established and based.
Let me move to some of the questions that we must raise and answer today, openly and transparently, and with full access to ONS record-level data. I am not saying that that should be disclosed to all and sundry, but surely the Government cannot defend the position that they are not willing to release that information to interested clinicians and clinical academics as a minimum. Those are the people who need to interrogate the data. It is of little relevance to me—I do not have the means or academic ability to interpret it—but it is something that interested clinical academics should have access to.
Let me move on to what we know about some of the issues surrounding mRNA technology. We know that it does not replicate locally, as we were assured it would do on launch. It metastasises to distant tissue, and replicates spike protein systemically distant from the site of administration. That is problematic for a number of reasons. According to the University of London Professor of Oncology, and principal of the Institute for Cancer Vaccines and Immunotherapy, Professor Angus Dalgleish, this has precipitated various serious and sometimes fatal consequences due to antibody development mediated by the spike protein. I will not go into the detail of that, but at a meeting convened by the hon. Member for North West Leicestershire, Professor Dalgleish told us that the UK Government and their agencies are in serious denial about this issue, resulting in many deaths being poorly understood.
Let me give a couple of examples. Vaccine-induced immune thrombotic thrombocytopenia is one of the principal causes of blood clot formation, which can cause stroke, pulmonary emboli, and other cardiac-related events including heart attacks, all of which can be life-limiting or fatal. Another antibody linked to the spike protein exerts an effect on myelin, and is associated with Guillain-Barré syndrome and transverse myelitis, which is a swelling around the spinal cord. Professor Dalgleish believes that that constitutes medical negligence, because the facts are there for all to see. He contends that many deaths are as a direct result of unnecessary vaccination. Furthermore, he advises that there are a greater number of yellow cards in MHRA for covid vaccines than for all other vaccines recorded, and nothing has really been done.
In a recent written answer to me, it was confirmed that the MHRA has received 489,004 spontaneous suspected adverse drug reaction reports relating to the covid-19 vaccine, up to and including 28 February this year. Across the United Kingdom, 2,734 of those reports were associated with a fatal outcome. Of course the true number is unknown—that is the nature of yellow card reporting, as only a fraction of adverse events are reported—and that is probably because of limited public awareness about some of the potential consequences and complications of vaccines, and the well-understood under-reporting of those adverse events. That is important, because the yellow card system is a key element of safe and effective clinical care. If things are not being evaluated properly, I can think of no greater betrayal of the MHRA’s clinical governance responsibility. I suggest that accountability for that must be swift and decisive. The rigorous assessment of these data is essential and must be actioned urgently. Will the Minister now engage with the MHRA and invite it to come to the House to explain the facts on these reports?
Another issue, which arises from a further written question that I tabled, relates to the role of the MHRA. It has a crucial role—in fact, it is a statutory function—to provide post-marketing surveillance and to operate the yellow card system, but the Minister responded to my question about the assessment of the potential implications of the BMJ article “Pfizer-BioNTech vaccine is ‘likely’ responsible for deaths of some elderly patients, Norwegian review finds” by stating:
“The MHRA communicates safety advice based upon consideration of the totality of evidence from all relevant information sources, rather than the strengths and limitations of individual data sources.”
Surely, a fundamental step in any meta-analysis of published data is to interrogate the robustness of those data and for the public to have confidence that that is happening.
That point links right back to where I started, on the Cass report. One of the fundamental failings that the report identified was circular citation among various different organisations. They were validating one another’s position to create a false impression that there was an evidence base for the practice they were involved in. If the MHRA will say, “We do not interrogate the data when we do a meta-analysis,” who does? Who will validate the data? If I can hand over to the MHRA a whole load of numbers and it will just count them and accept that I have said my methodological rigour is robust, that is not good enough as far as I am concerned.
The Minister’s response to my written question was that the MHRA does not
“assign causality at the level of individual reports,”
as that is not its responsibility. If that is the case, whose responsibility is it? Who is interrogating the data and making that decision? If no one is, how can we get from correlation to a developed picture of causation? That is an essential step. It raises fundamental questions about that responsibility and the reliability of the data that the MHRA is relying on. If we are to learn anything from the general implications of the Cass report, we must have a clear steer from the MHRA on how these fundamental scientific principles will be observed and upheld.
I will canter through some important published evidence, which comes back to the correlation/causation discussion. In a 2021 study looking at cardiac inflammatory markers in patients receiving mRNA vaccines, Steven Gundry observed that mRNA vaccination numerically increased markers
“previously described by others for denoting inflammation on the endothelium and T cell infiltration of cardiac muscle”
in a patient population receiving the vaccine. A 2022 study by Fraiman et al. noted that the
“excess risk of serious adverse events”
identified in their study pointed
“to the need for formal harm-benefit analyses”.
That suggestion is wholly consistent with the principles set out in the declaration of Helsinki and is an ethical imperative.
In 2023, a pre-print Lancet study by Nicolas Hulscher et al., including leading cardiologist Peter McCullough and Yale epidemiologist Harvey Risch, reviewed 325 autopsies after covid vaccination and found that 74% of the deaths were attributable to the vaccine. That study, which was published online, was then swiftly removed, allegedly for issues with ideological rigour. I wonder whether it was the MHRA that did the assessment of its rigour. Surely those data and findings—however problematic some of the methodology might have been—demand further scrutiny, not removal.
A December 2023 Lancet Regional Health study by Jonathan Pearson-Stuttard et al. examined excess mortality in England post the covid-19 pandemic and the implications for secondary prevention. It stated:
“Many countries, including the UK, have continued to experience an apparent excess of deaths long after the peaks associated with the COVID-19 pandemic in 2020 and 2021. Numbers of excess deaths estimated in this period are considerable.”
It noted that
“overall trends tend to be consistent across the various methods.”
It continued:
“The causes of these excess deaths are likely to be multiple…Further analysis by cause and by age- and sex-group may help quantify the relative contributions of these causes.”
I ask again: should we not at least be curious about this?
The study continued:
“The greatest numbers of excess deaths in the acute phase of the pandemic were in older adults. The pattern now is one of persisting excess deaths which are most prominent in relative terms in middle-aged and younger adults, with deaths from CVD causes and deaths in private homes being most affected.”
That is a completely different clinical picture. It continued:
“Timely and granular analyses are needed to describe such trends and so to inform prevention and disease management efforts.”
Documents recently disclosed as part of a freedom of information lawsuit against the US Food and Drug Administration indicate that the agency was aware that the safety monitoring system for Pfizer’s covid-19 vaccine was “not sufficient” for assessing associated heart conditions when it licensed the company’s vaccine. Those documents also reveal numerous manufacturing concerns with Pfizer batches that were released to the public and show that the FDA knew about a phenomenon known as vaccine-associated enhanced diseases in those who were vaccinated and experienced breakthrough covid-19.
Let us move on to what we do not know. We have had no real progress on the points raised in the debate, particularly on record-level data. We need either that data to be released to clinical academics and others or a cogent explanation for why that is not happening. Why were those concerns kept hidden by the FDA? Are similar concerns or issues being hidden by the UK Government? Some of the points made about the delay in the MHRA taking action on clinical impacts is relevant to that point.
According to a House of Commons Library briefing, the Government-operated vaccine damage payment scheme, which has been discussed in both this debate and the previous one, provides only a one-off tax-free payment, which is currently a modest £120,000, to applicants where a vaccine has caused severe disablement. Data on VDPS claims relating to covid-19 vaccination is not routinely published, so we do not have particular metrics that establish how many claims are being made against those vaccines.
The most recent data is from September 2023. According to the NHS Business Services Authority, at that time it had received 7,160 claims relating to covid-19. Following medical assessment, 142 claims—just under 2%—were awarded, and 3,030 were rejected. A further 192 claims were found to be “invalid”. We need to understand why that was. What are claims being measured against and who is interpreting the clinical assessment information? We must also ask whether the exclusion criteria are reliable, given the concerns raised in the debate.
Based on the data that I have here, there are currently 3,796 unresolved claims, 1,010 of which have been unresolved for more than six months. If the 142 successful claims receive the full payment, the total cost will be around £17 million. If there are a further 177 successful claims from the unresolved cases, the associated cost will be a further £21 million. I am advised that the Government set aside some funding for this issue, but this has the hallmarks of the contaminated blood scandal written all over it. We must get ahead of the game and make sure that people get the compensation that they desperately need at a time when it is important to them.
There is another question: why are the Government so willing to pick up the tab on vaccine injury, however inadequate the scheme is, given the fatalities and the significant life-limiting impact on the victims? These concerns have been amplified significantly following the publication in The Spectator Australia of an account by genomics scientist Kevin McKernan of his accidental discovery. It states:
“While running an experiment in his Boston lab, McKernan used some vials of mRNA Pfizer and Moderna Covid vaccines as controls. He was ‘shocked’ to find that they were allegedly contaminated with tiny fragments of plasmid DNA.”
His concern has been considered further by Professor Angus Dalgleish, who noted that the contaminant, simian virus 40, is
“a sequence that is ‘used to drive DNA into the nucleus, especially in gene therapies’ and that this is ‘something that regulatory agencies around the world have specifically said is not possible with the mRNA vaccines’. These SV40 promotors are also well recognised as being oncogenic”—
or cancer-inducing genetic material. Other scientists have confirmed those findings. Professor Dalgleish further notes:
“To put it bluntly, this means that they are not vaccines at all but a…Genetically Modified Organism that should have been subject to totally different regulatory conditions and certainly not be classed as vaccines.”
Worryingly, Professor Dalgleish also notes that oncologists have contacted him from across the world, and the consensus is that this is thought to be precipitating relapse in melanoma, lymphoma, leukaemia and kidney cancers. He concludes with the following warning:
“To advise booster vaccines, as is the current case, is no more and no less than medical incompetence; to continue to do so”—
with his cited evidence—
“is medical negligence which can carry a custodial sentence.”