A_Clinical_Trial_Revisited

and an alleged ethical consideration

I have heard that once a clinical trial has shown a 'vaccine' to be "Safe and Effective" history suggests that ethical considerations will prevent a regulator from approving a replacement placebo controlled trial. 
There are logical flaws to that position. 
1. The US Supreme Court has declared that all vaccines are inherently dangerous.
2. To the extent that the above statement is true, all vaccines must be evaluated for the benefits they confer against the harms they cause before they can be considered safe or considered effective.
3. The Test and the Evaluation must encompass and record all the known variables in sufficient detail against a known standard of ethical consideration to ensure that the Trial in itself is complete. Thus the Trial Data must be sufficiently robust to refute any need for further Trials. 
4. The Trial design must also define the design limits of the product. 

In essence, if at some point in time during or after the trial, a re-evaluation of an expanded test data suggests that the product creates less good than harms, the product can no longer be declared ‘Safe and Effective’ and the ethical consideration argument fails. 

It seems possible, even probable, that the need for another placebo controlled Clinical Trial will then be unnecessary or impractical. And that is before the question of finding naive patients is considered. 

This logic may seem otherworldly, but it is necessary to set it out before getting into the real meat of this post. 

In a comment to an earlier post [1] I formed a view that Pfizer’s Covid-19 Clinical trial was designed as a marketing exercise. Provided that Pfizer’s goal of maximising return on investment aligns with the Public Interest there is no difficulty in their doing so. The question then becomes whether these two objectives are closely aligned, and that resolves itself into whether the product is ‘Safe or Effective’, and that gets into data and the evaluation in the Reports. 

This Post revisits two [2][3] Reports on Pfizer’s Covid-19 Clinical Trial. 

This Post’s intent is to discover whether, with the present knowledge base available to a lay person, Pfizer’s Trial Data is sufficiently robust. Some notes: 

The Trial Design omitted all-cause mortality as a governing endpoint.

Some specific events within seven days of inoculation were omitted from the Trial by design. 

Recruitment into the Trial of 44,165 over 16 year olds over a wide geographical area began on 27 July 2020 and ended on 29 October 2020. An initial assessment of each participant began two months later, with dates varying with the progess of recruitment and inoculation. From some point in December 2020 the participants were given the opportunity to unblind, and if in the placebo group, to have the product injected. 

Follow-ups took place at one and six months after inoculation, and at that point the Trial effectively ended, with data finalised at 13th March 2021. 

In order to assess the Pfizer Covid-19 Clinical Trial results as recorded in the reports the Trial Design is modelled using the population of England in December 2020 as a template. 

The average age in the study is 52 years, the average age as modelled is 45. Since precise data on study ages is not presently available, adjusting to these unknown values is left for a later study. 

Of the 22,083 who received the first inoculation, documentation suggests that they may be more susceptible to coronavirus infection during the first seven days. If circumstances favoured say, one in 100 with infection, then some 221 in the Vax group would have shown that effect. The data from the Trial does not support this thesis. Whether further disclosure of the trial data can shed some further enlightenment remains to be seen. 

In order to assess all-cause-mortality in the Test, calculations are based as follows : for the Vax group; six months; and for the ‘placebo’ group : four months plus two months Vax.

The calculated all-cause-mortality at six months for 44,166 person is 213. Of these half were in the aged 80 and above sector.  

The Pfizer trial data records that 34 persons died during their 6-month trial. 
Twenty were in the Vax group; and fourteen in the placebo group. [5]

For clarification, I am aware of errors in the ONS England data, of the order of something in the low single percentages. I am therefore unable to reconcile the differences in these outcomes. 

Here are some numbers in support of the Model. 

Population of England 2020 : 56,550,138 [4]
All-cause-Deaths in England, 2019 : 494,292
Over 15 population, England 2020  : 46,335.654 [4]
All-cause-Deaths in above population : 491,092 (*est)

Pro-rata, aged over 15, deaths per 44,165 at 2019 rates = 468 per year. 

Hence, in six months, in a year “without Covid”, 234 people would die in a population of 44,165 over the age of 15 living in England.   

This is almost seven times, within distance of an order of magnitude greater that the all-cause-mortality stated in the Pfizer Covid-19 Clinical Trial. 

If this difference cannot be reconciled, what does that say about the rest of the data? How can the product be said to be “Safe and Effective”? 

What can be said about the ethics that prevent a proper re-evaluation of Pfizer’s Covid-19 Clinical Trial? Did Pfizer omit any estimates of all-cause-mortality in their Trial Design? How could they not know?

As to modelling possible additional deaths from product harms, that’s best left to another day. There is already a serious problem here. 

This is the “dangerous magical thinking” the WHO guy warned about at Event201. 

[1] https://richarda697.substack.com/p/the_clinical_trial

[2] https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

[3] https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.full.pdf

[4] https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/articles/overviewoftheukpopulation/2020

[5] See ‘The Real Anthony Fauci’ Robert F Kennedy Jr, p79