Before reading (and after finishing) it’s worth listening to Peter Seeger’s There was a Young Woman.
Governments are considering mandating, or already have mandated an unproven technology, against a background of vaccine approval and pharmacovigilance processes that leave a lot to be desired even in the case of proven technologies.
The technologies, now designated as vaccines, are novel, so much so that they led in 2021 to a change in the dictionary definition of a vaccine (See posts next week).
The techniques used to evaluate these novel agents are not new but have been corrupted and no longer meet the norms of science. The points made in The Eclipse of Health Care about the evidence regulators, and investigators get to see hold for these new technologies also.
Icon is the CRO that co-ordinated the trial of a vaccine that is sometimes now called Comirnaty, and more generally called Pfizer. Icon subcontracted to other companies, at some point engaging Platinum Research Ltd, which includes Ventavia, the CRO with concerning trial practices that was the subject of Paul Thacker’s Nov 2 BMJ paper. Icon boast that the main trial was conducted with unprecedented speed and pitch for further business based on this.
Icon staff wrote the papers reporting the results of these trials submitted with BioNTech as the sponsor. Of the 29 listed ‘authors’ on the main trial, there are 3 Americans, 4 who run for profit clinical trial centres overseas, and 19 company people of whom 17 are linked to Pfizer and 2 to BioNTech. There are few clinicians on these papers, and likely none have met any of the trial subjects, particularly those who have been harmed.
These novel agents were authorized for emergency use (EUA) starting with Icon/Pfizer’s RCT. They were later approved without additional safety or efficacy data. Approval made mandates possible; these are not possible under an EUA.
My argument offers no views on Covid, other than it is an infection to be managed.
It offers a view on processes. Government, regulators, and guideline makers have agreed with, or not contested,- see Warning re Health. The points being made here about clinical trial data sequestration and their agreement is the basis for this letter.
To disprove the case, government would have to be able to show there is access to the clinical trial data for these new technologies, that there are processes in place to establish what harms these technologies are causing, and there is ongoing research on treatment options for those who are harmed by vaccines.
As it stands, my view cannot be pitched against opposing views, with a government who has to manage a crisis being let by the legal system use its discretion to choose which set of views to believe. As a matter of logic, no scientists can endorse withholding trial data. And if harms are denied, no-one can assert research is being done on how to recognise and treat them.
The government does not have a right to substitute business considerations or hocus-pocus for science and mandate on this basis, especially in a time of crisis when trust is important.
Rather than establish the effectiveness of a treatment, many clinical trials use surrogate outcomes as a measure of efficacy. Thus, with SSRI antidepressants, while there are falls in depression rating scale scores, there are more lives lost and suicide attempts on treatment than on placebo, suggesting rating scale changes are surrogates that do not correlate with the outcomes we want.
Based on the trial results reported for these new mRNA technologies on measures of effectiveness, such as death, we know that in the Icon trial there were at least 30% more deaths on vaccines than placebo. Other measures of what most people might regard as effectiveness, such as hospitalization for serious illness or admission to intensive care units, are not reported.
The measures reported are symptomatic infection confirmed by PCR test. Now this might not seem like a surrogate, any more than depression rating scales scores do, but it is now clear that these agents do not block infection or transmission and so cannot help us achieve herd immunity, which along with lives saved and an avoidance of significant disability, is a measure of ‘vaccine’ effectiveness.
Subjects on active treatment in trials who developed Covid after the first dose and prior to 14 days after a second dose were not counted, as this would be unfair to the vaccine, when a strict Intention-to-Treat analysis would include them.
Health Canada makes a Clinical Study Report for the Pfizer trial available. In this multiple tables give slightly different figures for those recruited and dropping out of the trial. Over 1000 subjects appear to have dropped out in both the vaccine and placebo arms having contracted an infection. Analysing the outcomes with these left in would make a difference to the conclusions.
The PCR testing used to establish who was infected offers further ambiguity. There is no consensus on what threshold for these tests reliably distinguishes a Covid infection from viral fragments. The commonly used cycle thresholds for PCR are greater than 30 and tests positive on this basis commonly do not support viral cultures.
Another large number of people appear to have disappeared into a gap between a first dose of the vaccine and 14, or more, days after the second dose – in this case many more on the vaccine (300+) than placebo (60), with a similar excess in Pfizer’s children’s trial.
Companies have a track record in making safety events disappear into gaps like this. Given the BMJ Nov 2 report about how these trials were conducted, and in the absence of details on the centres in which drop-outs happened, there can be no guarantees the reported reasons for dropouts hold water.
One might argue that safety events can be left out of a consideration of efficacy, but clearly in the case of suicide on SSRIs this should not be the case. Where the relationship between efficacy and effectiveness is as loose as with SSRIs, as it appears to be for these new technologies, leaving serious safety events like death out of both efficacy and safety analyses is problematic and particularly problematic when serious safety events are portrayed widely as occurring in those who are called unvaccinated but have in fact had a first dose of vaccine.
(The SSRI trials offer a precedent for counting vaccine harms as placebo harms – see post next week – and in that case company conduct has been recognized as inappropriate).
The available trial data offers slender evidence for vaccine efficacy and none for effectiveness. Without full access to the data, especially in the light of the BMJ report about the behaviour of Ventavia, the sub-contracted CRO helping to run the Icon/Pfizer trial, it is impossible to establish what happened in these trials.
In the case of the SSRIs, when it became possible to pierce through company obfuscations and show that evidence from company RCTs demonstrated a link between SSRIs and suicide, companies and others turned to real world evidence to deny this link. This evidence was used to claim that what appeared to be a hazard from RCTs was not one in the real-world SSRI real world equivalents to mRNA harms will be detailed further in next week’s posts.
As with SSRIs, it is only when we establish what happened in the core RCTs that we can begin to establish how the apparent real-world evidence might have arisen.
For instance, if SSRIs work wonderfully well, then real world evidence of falling suicide rates might well map on to their effectiveness. When, however, in trials SSRI were shown to offer scant benefits and an increased risk of suicide, researchers began to note that suicide rates were falling before SSRIs emerged and correlate better with falling autopsy rates than with increased SSRI use. In addition, they found that increased SSRI treatment correlates well with increased rates for deaths of undetermined cause.
Similarly, knowing exactly what happened in vaccine RCTs is key to establishing what is happening in the real world.
There are many possible explanations for what is happening following vaccination. An enduring lack of consensus about what a case of Covid is opens a gap through which all kinds of claims can be marched.
There is scope to confuse deaths with concomitant Covid and Covid deaths. In one large UK sample involving children 60% of Covid positive deaths were not Covid deaths
In seeking to nudge people toward a treatment they genuinely believe might be helpful, public health officers may have been economical with the truth. They need to be allowed some latitude in a pandemic but latitude risks toppling over into lying.
Another option is that rather than immunize people, which it is hard to say these agents do, some of these agents may ‘treat’ – that is act like a drug with a beneficial effect of reducing the likelihood of a Covid pneumonia and consequent death.
In fact we do not have any real world data. We are given hospital and ICU data for the unvaccinated that includes people who are up to two weeks after a first dose of vaccine – a time when many are injured or killed by their vaccine. To understand what is going on we need rates of admission and some idea as to how many need to be vaccinated to prevent one all-cause death (not just death from Covid), one ICU admission or one admission to hospital – and we need this broken out by age. What are these figures like for younger and for older subjects.
Access to the RCT data will encourage a range of experts to put serious thought into explaining the real-world data. It seems likely that access will make it more difficult to attribute all good real-world data to vaccine effectiveness and safety.
Beyond this, there remains a lot of real-world evidence still to come in. In the case of Di-Ethyl-Stilbestrol (DES) it took thirty years before clinicians spotted its major hazard – vaginal cancer in the daughters of women who took it during pregnancy.
In contrast, in the case of most drugs now, from SSRIs to leukotriene antagonists like montelukast, the ghostwriting of clinical trials and sequestration of trial data mean that thirty years after clinicians first described these hazards companies can get away with denying the hazards exist.
In the case of vaccines, we likely face decades before unexpected hazards emerge and in addition decades before there is a recognition of serious hazards clinicians are currently reporting.
The companies deny there were serious adverse events (SAE), events that result in hospitalization or death, in their trials.
In the Astra-Zeneca vaccine trial, the resulting Falsey et al New England Journal of Medicine (NEJM) publication mentioned that people who withdrew from the study have not been included in the analysis. Brianne Dressen was a subject in this trial who was not included in the analysis, but she did not withdraw. Ms. Dressen would be happy to be contacted by you.
As outlined in New England Journal of Misinformation, Bri Dressen wrote a letter for publication to NEJM making clear that, after Astra-Zeneca broke the blind and confirmed she was on active treatment, they told her not to take a second dose. They also removed the electronic device given to her for reporting ongoing adverse events (Appendix 2).
The NEJM editor, Eric Rubin, responded to Dressen that NEJM would not be publishing the letter. On Nov 15, 2021, at 3:19 PM, he further emailed:
Dear Ms. Dressen,
The best we could do is forward your letter to the manufacturer. Only they are in a position to see the primary data. But you can do that yourself and I would encourage you to do so. Only you can provide the information that they can use to investigate.
Brianne Dressen subsequently made it clear to Dr Rubin that she was not the only A-Z trial participant to whom this happened and that the NEJM’s Falsey publication breaches good clinical trial reporting guidelines. Rubin still refused to budge.
The Astra-Zeneca trial gave electronic devices to volunteers for safety monitoring. This had a set of prepopulated events that subjects in the trial could respond to – they could report on headaches, or fever, but not on the early signs of a transverse myelitis, Guillain-Barre Syndrome, a myopathic disorder, myocarditis or thromboses.
In the Icon/Pfizer trial of 12–15-year-olds, 13-year-old Maddie De Garay spent close to two months in hospital after suffering adverse reactions that left her in a wheelchair and fed by nasogastric tube. I have examined Ms. De Garay and all her medical records.
The NEJM publication of this trial (Frenck et al) states there were no serious vaccine related adverse events. In the De Garay case, the investigators in their publication appear to depend on the report of an allergist, who introduced the idea of a functional disorder, to claim that Maddie De Garay has a functional illness. This implies she had a predisposition to hysteria and therefore the vaccine cannot be said to have caused this. The allergist consulted the lead investigator, Dr Frenck, before committing this entry to the medical record. His entry included the detail that he had consulted with Dr Frenck, who is based in the hospital Ms De Garay was being seen in – that the trial monitors insisted she be taken to rather than a hospital nearer home – See Appendix 3.
My examination of Ms. De Garay and review of her medical record suggests this trial designation is not just wrong but quite unbelievable. It is perhaps even sociopathic as it appears that, in order to maintain Pfizer’s position, this young woman is not getting the treatment that would be ordinarily indicated for the kind of problems she has. Instead based on a claimed functional disorder, she has been directed to a mental health facility.
There seems little point writing to Dr Rubin about this. On October 26, three weeks before his email to Brianne Dressen, Eric Rubin was a member of the FDA Vaccines and Related Biological Products Advisory Committee convened to review the data on Pfizer’s application, based on Icon trials, to approve their vaccine for 5–11-year-olds. He voted for approval saying:
“We are never going to learn how safe this vaccine is unless we start giving it. That’s just the way it goes. That’s how we found out about rare complications of other vaccines”.
Given Dr Rubin told Brianne Dressen that NEJM don’t publish case reports, it is difficult to see that NEJM will ever contribute to the safety profile of these agents.
The treatment of Ms De Garay raises another prospect. In the case of vaccinated minors, with neurological problems of the type she has, few if any paediatricians or family doctors have seen older people’s disorders such as demyelinating events and strokes in the young. Accordingly, many will not know what they are seeing or how to respond, making a turn to a diagnosis like hysteria (functional neurological disorder) more likely.
As with Brianne Dressen, Maddie De Garay had a prepopulated electronic device that only let her record indicators like headache, fever etc but none of the clinical problems she has ended up with. (See Appendix 3 for details of the De Garay case and the Frenck NEJM publication).
The CSRs on these Icon trials, possibly written by Icon, have numerous tables of adverse events reported in the course of the trial. Prepopulated electronic devices make these tables meaningless.
The safety arms of the Icon/Pfizer trials were dismantled, two months after recruitment stopped. The blind was broken and all of those who had been on placebo were invited to have the vaccination.
In other trials of related biological products, the existence of mandates and the need to get vaccine passports have encouraged others of those who have been in trials, to get extra jabs after the trial ended in order to be able to get vaccine passports – supporting their individual liberties but compromising communal safety.
Finally, while Icon congratulated themselves on co-ordinating 152 recruitment sites, 130 in the US, to deliver a speedy result, anyone familiar with a trial of aripiprazole as a maintenance treatment in bipolar disorder might wonder about these sites, especially trial business operations. Aripiprazole showed no benefit over placebo in 30 US sites, but was wonderfully effective in 3 non-US sites, the results from which made the overall result positive. FDA noted this odd pattern of results but did nothing.
The Covid vaccines make clear that our current pharmacovigilance systems do not work.
In less than a year, there have been several fold more deaths following Covid vaccines reported to MHRA in the UK and CDC in the US than after all other vaccines combined over the last 20 years but regulators have not conceded a link between any of these deaths and the vaccines.
There are certainly a great number of deaths from Covid. These primarily involve pneumonias and occur in hospital settings and allow clinicians to link many to Covid and to register these deaths and maintain figures that have some validity.
A Nature Medicine paper, referenced above, however, looking at all deaths in British children linked to Covid found that 60 % of children who died and were Covid positive did not have a Covid caused death.
Deaths from the vaccine, in contrast, happen at home or in settings other than hospitals. No attempts are made to link the deaths to the vaccine (other than in Norway where 10% of deaths after vaccination in residential homes were deemed to be likely linked to the vaccine and 26% possibly linked. No register of deaths lets us know how common vaccine deaths are relative to Covid deaths.
The issues of myocarditis, especially in younger people, and thrombotic events have been brought to the fore by clinicians. In Britain, where most reports to regulators come from doctors, there have been 10-times more reports of neurological events than from myocarditis and thromboses combined. There are few hints of these neurological difficulties in the published articles on these trials, even though cases of transverse myelitis led to a temporary halt of the Astra-Zeneca trial, which then continued producing more cases of transverse myelitis which the company managed to make vanish.
Brianne Dressen was an early volunteer for this A-Z trial when it resumed. Her case and Maddie De Garay above illustrate how companies can manage to lose seriously injured people.
Some countries like Norway, Sweden, and France have more robust pharmacovigilance systems than the UK, often employing clinicians distributed around a country rather than operating as a central bureaucracy. These countries have done better than Britain has in this pandemic in recognising myocarditis and thromboses, and recognizing vaccine related adverse events, such as narcolepsy, in previous pandemics.
For therapeutic agents in general, the United States has depended on companies to undertake the pharmacovigilance and to take steps to ward off the liabilities they face if injured patients take legal actions, as they can in the US. Companies have been far more likely to make a cause-and-effect link to their product than FDA or CDC have been.
The increasing control these companies have over the medical literature, however, means that in the case of clear adverse events, as the SSRI story indicates, they stonewall on warnings to an ever-greater extent, and are confident that, if warnings are put in place, they can deploy real-world ‘evidence’ or other methods to ensure clinicians ignore them – few doctors believe SSRIs cause suicide, dependence or can obliterate our ability to make love ever again even in the face of Black Box Warnings.
With vaccines, and the removal of liabilities, companies have been able to focus on hard-nosed contract negotiations, rather than on pharmacovigilance, leaving CDC and FDA, agencies with little expertise or motivation in this area, holding the pharmacovigilance baby. Mandates further increase the pressure on regulators to partner with companies rather than pursue safety.
Even though FDA do little pharmacovigilance, when they approve new products with recognized or potential hazards, they commonly invite companies to craft Risk Evaluation and Mitigation Strategies (REMS). Not so in this case.
REMS packages are a step up from a toothless set of Phase IV trials, notionally designed for pharmacovigilance purposes but more often used to market the product. These have not been requested either.
If something goes wrong with these new technologies, the costs will fall on governments, who are even less likely than pharmaceutical companies to accept there might be harms. In Britain taxpayers will foot the bill and it is in our interests to have harms recognized as soon as possible – something that mandates inhibit.
Governments have known about the data sequestration in company trials and ghostwriting problems outlined here for several decades but have done nothing. They appear to be thinking magically rather than rationally.
We have been here before with Tamiflu and a previous viral pandemic. On the back of hidden data on both efficacy and harms, and a ghostwritten literature, governments stockpiled billions of dollars’ worth of Tamiflu, a drug now recognised as harmful junk. The exigencies of needing to be seen to do something in the face of a pandemic, and having already spent large amounts of money, appear to have inhibited bureaucrats and politicians from recognizing a con.
Unfortunately, to this day, while many doctors are semi-aware that Tamiflu is ineffective, faced with someone with a viral illness they prescribe it saying: “well what else can we do”.
Their wish to help is commendable. Their failure to appreciate the hazards is frightening.
The arguments put forward in favour of mandates by clinicians, ethicists, politicians, and others depend heavily on assumptions about the integrity of the clinical trial data in respect of the efficacy and safety of these novel technologies, the integrity of the regulatory process, the integrity of pharmacovigilance processes, as well as a belief that if people are harmed by the vaccine they will be received sympathetically by healthcare systems and their injuries will be both remediable and remedied.
None of these positions can be held with confidence in the light of the uncontested evidence about the underlying processes detailed here.
During the 10 months these new technologies have been in use before approval and subsequent mandating, see Mandates for Vaccines, we should have had:
None of the arguments in favour of mandates recognize any of these issues.
Instead, arguments for mandates claim it is the duty of clinicians to first do no harm – see Daniel Sokol (who hasn’t answered this post when sent to him), but these arguments fall aside with the now accepted evidence that those who are vaccinated can be infected and transmit that infection. Nor is it possible to make an evidence-based case against the proposal that those who are infected naturally are more likely to be immune and less likely to do harm to others than those who are vaccinated.
None of the many opinions in favour of mandates take account of the climate mandates create. A growing number of deaths, and significant harms on these technologies are being denied and discounted. The denial of these harms mean that healthcare staff fail to treat these patients decently and are not able to treat them effectively.
A recognition of the harms we are causing with our treatments should be at the centre of medical practice. Inhibiting health carers from recognizing harms transforms health care in health services.
While the key reason to recognize these harms is the Hippocratic injunction to avoid making things worse for our patients, doctors might also consider this:
If our treatments are marvellously effective and free of harms, it would be reasonable for those who run health services today to decide that prescribing could be done by much less expensive staff or technicians. There is already a significant push in this direction.
Those against mandates are characterized as asserting a prior importance of individual liberties. My argument hinges on the centrality of science to modern medicine, our values, and our civilization. It is an argument based on the freedom we achieve through communal striving rather than a claim based on individual liberty.
Medicine in the last thirty years has retreated from this common ground. Far from mandates securing a safe retreat, they further imperil the common good and support corporate libertines.
At present healthcare staff do not have the option to refuse vaccination. An option to take a vaccine, as these have until recently been understood – that is not based on mRNA or DNA technology – is now possible if the government made it available. Government could transform healthcare if they approved a product provided by a company committed to transparency.
We have a Covid crisis. We also have a Pandemic of Overtreatment that had caused Life Expectancy to fall pre-Covid. In Ontario with a population of 14.5 million there have been on average 5 Covid deaths each day last week, much less than from Road Traffic Accidents and much much less than from over-treatment.
The factors outlined here, clinical trial data sequestration and ghostwriting, cannot but have contributed to deaths in this crisis, and a turn to mandates as a solution.
While inequality and poverty contribute to reduced life expectancy for some, the factors outlined here cannot but have contributed to a huge widely acknowledged increase in medication intake and the emergence of a phenomenon, polypharmacy, only recently described, and even more recently noted as a contributor to stalling or falling life expectancies.
The process factors have contributed to both crises in general and likely specifically contributed to the Covid debacle in care homes for older people where polypharmacy is pronounced.
Early in the pandemic, a colleague and I wrote a short paper on the desirability of reviewing the medication burdens of older people in residential care. All our major journals – NEJ Misinformation, Lancet, JAMA and BMJ turned this paper down, without review – see Dennis the Menace. Three epidemiological studies have since confirmed our proposal, Dutch, Scottish and Swedish, placing medication burden, second only to age, as a risk factor for death.
Our falling life expectancies are a parallel crisis to the Covid crisis, contributing to a greater morbidity and mortality than Covid but receiving less attention.
There is no science that can be used to support mandatory ‘vaccines’ for healthcare staff. The sequestration of trial data makes valid consent impossible.
Being asked about courage conjures up an image of young women for me. They don’t beat their chest about it.
They are more attuned to an Us than young men are. More attuned to Harms than men. Harms and a consensus about harms is where the science lies in medical care. Mandates are almost by definition antithetical to science.
Greta Thunberg is a great example of this kind of courage except for the fact that the current generation of young women while standing up for the globe are leading the chase to wipe out natural resilience and immunity with pharmaceutical technologies. They swallow the health lie to an ever greater extent than men and until this changes our problems are likely to deepen.
We need a Lysistrata – see They Used to Call it Medicine.