The Need for Mandatory Reporting of Adverse Events: Part Four

Guy Hatchard PhD has a background in statistical analysis and was an employee of Genetic ID, a global safety testing and certification company.

The Need for Mandatory Reporting of Adverse Events

On October 28th I wrote to all MPs and urged the government to put in place mandatory reporting of adverse events, so that their extent could be properly assessed.

At the time, Michael Baker, my gene therapist colleague, myself, and almost everyone else were unaware of the inadequate protocols that had been used to test the novel covid vaccines. Of course, the trials had to be almost impossibly short because of the sense of urgency, but their other shortcomings have only recently come to light.

Being short trials there was always going to be uncertainty about the long term effects, but we presumed that any immediate dangers of vaccination were going to be detected and documented before approval for emergency use. Journal papers had already been published reporting that the vaccines were highly effective and very safe.

Early in November, the BMJ blew the whistle on shortcomings at one trial location for the Pfizer vaccine—some data had been falsified. Alarming though this sounded, we hoped the errors were minor and resulted from the logistics involved in the short time frames and from the sloppy quality control of one contractor. Last week this hope was dashed by an investigative journalist from Australia, Maryanne Demasi PhD. Ms Demasi found that the Pfizer and AstraZeneca trials used new digital apps to gather patient data on adverse effects. The reporting options on these apps had only limited predetermined choices and gave little or no opportunity to describe symptoms if they departed from the multi-choice scheme of mostly mild adverse events.

Brianne Dressen was a participant in the AstraZeneca (AZD1222) trial. She suffered a severe adverse reaction after the first injection and became disabled. She was ‘unblinded’ from the trial, her smartphone app was disabled, she was advised not to have the second injection, and crucially the reports of her adverse event were never recorded in the final publication of the trial in the New England Journal of Medicine (NEJM).

As participants suffering serious adverse events like Ms Dressen were withdrawn, it is no wonder that whilst the occurrences of mild adverse events were reported as significant, the occurrence of serious events was reported as insignificant. Ms Dressen complained to the editor of the NEJM, but he refused to correct the inaccuracies, thereby blinding the public, governments, and scientists to the possibility that adverse events could be very serious indeed.

Ms Dressen’s experience was not an isolated event, there were others. The recent Pfizer trial results of 12-15 year olds states there were “no serious vaccine-related adverse events”. But Ms Demasi reports a serious adverse event excluded from this study also—a thirteen-year-old girl now confined to a wheelchair. Moreover, the AstraZeneca protocol had excluded adverse events resulting in death for the five weeks immediately after the first inoculation—a fatal safety testing flaw.

What is the take home lesson from this? Drug side effects are known to be the third leading cause of death. In 2009 Pfizer paid out $2.3 billion in damages for criminally misbranding drugs. The Ministry of Health should have been more suspicious. Knowing that the safety trials were short, they should have alerted GPs and hospital staff to expect the unexpected, report all adverse events, and send accurate and complete reports to Medsafe promptly. This didn’t happen.

More importantly, the number of adverse events and deaths that Medsafe did receive was large, many times greater (possibly around 50 times greater) than any previous vaccine programme. There should have been a vigorous effort on the part of Medsafe to find out what sort of people were at greatest risk. Ignoring this was not just an oversight, it is possibly criminal. It may have affected the health of a
very large number of recipients.

Some of these only consented to vaccination under threat of loss of employment. Moreover, the Ministry of Health largely refused to issue vaccine exemptions to people who had already had an adverse reaction to the first covid dose or to a past vaccination.

Did Jacinda Ardern Ignore Red Flags?

The failure to alert the public that there was a measurable and significant risk to vaccination was compounded by false government assurances that there was no risk. Jacinda Ardern herself cannot have been unaware of potential risks, yet on occasions she dismissed questions at press conferences about adverse events, giving the impression that such concerns were without foundation.

The 33,000 comments on her Facebook page, after she advised people to enquire of their vaccinated friends whether they were unharmed, should not have been ignored nor quickly deleted. Her rejection of safety concerns and possible long term risks can only be described as an inexcusable failure to inform herself, or could it possibly have been fuelled by a deliberate attempt on the part of Medsafe to hide or downplay the significance of adverse event data?

The safety reassurances Ardern, Bloomfield, and Hipkins gave repeatedly at press conferences and advertised to the public, also mitigated against adverse effect reporting. I know of a number of people who did not suspect that their cardiac events subsequent to vaccination could be related. The public perception of safety has become so entrenched that individuals posting about their adverse event symptoms on social media are often mercilessly trolled. Medsafe has maintained that the very high level of adverse events is not necessarily related to vaccination, because they knew of no proven mechanism which would cause them.

With the recent publication of a number of scientific papers suggestive of risk, this position cannot be realistically maintained, even if it ever could be.

Viruses reports that the covid spike protein inhibits DNA repair in vitro. The New England Journal of Medicine reports that the spike protein may impair long term immune function. Cell Discovery reports that post vaccination symptoms mimic covid itself. Other research suggests that the spike protein can be long lived in the bloodstream and that the cell nucleus is not as well protected from mRNA vaccines as we thought.

Clearly the lack of clinical research expertise in the field of genomics, and specifically gene therapy risk assessment, on the Skegg Committee meant that such tentative concerns are not being factored into any discussion. The possible extent of adverse events is unknown and apparently being ignored. BUT, and it’s a big BUT, the main ignorance here concerns the possible long term effects of covid vaccination with an mRNA vaccine or a viral vector vaccine.

It cannot be over emphasised enough that these risks are unquantified and in a completely new field of bio technology unknowable within a short time frame. Certainly, there are some very highly qualified and respected leaders in the field who have struck a very cautious note when airing their views publicly. Did anyone ever have an honest conversation with Ardern about this? Should mandates be enforced when they are in essence a gamble with uncertain and unknowable odds?

What Lessons Can Be Learned?

In summary, Ardern set the pre-conditions for vaccine mandates as “safe, effective, and tested”, we have seen that none of these are reasonably satisfied. Yet she went ahead and ‘bet the farm’ on vaccine mandates. The watch word of my early dialogue with advisors was ‘caution’. At the beginning, they recognised the limitations of current knowledge. They ‘knew’ we had to explore all the options. This sensible approach has seemingly been replaced by a misplaced professional stamp of vaccine approval along with the exercise of political Jacinda power.

In the first world war, trench warfare was a failed strategy but its continued use was promoted by the establishment despite the horrendous loss of life. As we now face new variants, possibly impervious to vaccination, do we continue to maintain the fiction that universal mandated vaccination is a stand alone strategy?

Are we going to meekly submit to regular booster shots at shorter and shorter intervals, and to embrace new genetic vaccine formulations? Or do we recognise that we are at a turning point in our civilization whereby our most successful strategy will be improvements in our habits, our lifestyle, our diet? Do we recognise that, as in so many fields of endeavour, we have brought ourselves to our knees, and need to think again about the fundamentals of personal health and the environment?

Do I think that the NZ public can handle a mature and honest discussion? Yes. The decision to not only keep the public in the dark, but promote an entirely exaggerated and in some aspects false narrative appears as a misguided crusade. The scapegoating of the unvaccinated, despite the fact that the vaccinated can and do transmit covid easily, appears as a Machiavellian political plot. The willful suppression of the large scientific uncertainty surrounding many covid ‘facts’, through selective editing or blocking of information comes straight out of the playbook of tyrants. The lack of an early and dynamic effort to understand and evaluate early intervention treatments was an error that could lead to increased fatalities. The gap between evolving scientific knowledge and government fiction has become a gaping chasm.

A final word—why oh why hasn’t the media dug deeper? Where is well researched investigative reporting to be found? Why is there no balance? The media reporting of Covid in NZ is a lesson in itself and another story to be told at a future date by some brave and clear-minded investigator.

The origins of one-sided reporting are not hard to discern when you recognise that the government has discouraged the cash strapped media from investigating or striking a critical note using a well-financed carrot and stick approach. Large grants have been made to media outlets. Independent vaccine lobby groups have also financed media outlets. Yesterday in Stuff, a long, rambling, and selective piece of reporting, entitled Covid-19 NZ: Just how deadly is the virus? concluded with the comforting thought that the vaccine makes you younger. Praise the lord—the long lost elixir of eternal life has been discovered by the independent Stuff media group.

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