Informed Consent FI

Failure of Informed Consent Equaling Uninformed Coercion: Who is Accountable?

Informed Consent is especially topical at the moment with the inquest into the death of a young man from vaccine-induced myocarditis (inflammation of the heart muscle).  What was known and when, about the ability of the Pfizer covid vaccine to cause myocarditis?  Were consumers being advised of the risks?  What can be done if informed consent was inadequate?

We have done our best to get evidence of risk to the right people, including FOURTEEN letters directly to, or copied to, vaccine approver Medsafe, updating the names of numerous recently jabbed sudden cardiac deaths, as well as many scientific references supporting the much higher incidence of heart inflammation from the jabs as they came in. However,  it’s communications suggests Medsafe wasn’t interested in data contradicting the narrative. 

According to the Medsafe website, a Monitoring Communication was issued to the health workforce in June 2021 advising that myocarditis was a potential risk from this vaccine and that health professionals should report any possible case of this to CARM.  Medsafe advised that myocarditis cases that had been reported in relation to vaccination, had not been confirmed as due to the vaccine, were rare and mild, and did not appear to require treatment.

However, in July 2021 Medsafe issued an Alert Communication advising health professionals that Medsafe had concluded that myocarditis was a rare (fewer than 1 in a million overall) side effect from Pfizer vaccination.  It was being seen most commonly in younger men shortly after the second dose of vaccine.  The cases were generally mild, and patients recovered within a short time frame with standard treatment and rest.  Health care professionals were advised to recommend that anyone affected with symptoms (chest pain, shortness of breath or palpitations) seek immediate medical attention.

On 20 December 2021 Medsafe issued a Reminder Alert Communication about myocarditis and pericarditis after Pfizer vaccination following the death of the young man in question.  It was described as rare though this definition had changed from 1 case to 30 cases per million doses. (Currently myocarditis/pericarditis is listed on Medsafe Safety Report 44 as 81.8/million [908/11.1]) Vaccinators were advised that everyone should be informed about the risk of myocarditis, the symptoms to be concerned about and to seek urgent medical advice if symptoms occurred.  It was recommended that a written pamphlet be given at the time of vaccination.

The symptoms of concern were:

  • new-onset chest pain (or an increase in severity of existing chest pain), discomfort or heaviness
  • shortness of breath or difficulty breathing
  • an abnormal heartbeat or a racing fluttering feeling or a feeling of skipped heartbeats
  • dizziness, feeling lightheaded or fainting with the symptoms above.

We note that a number of people who have communicated with us about their experience with these exact symptoms, report not being taken seriously and being diagnosed with anxiety.

So, were patients being told of the risks of myocarditis prior to the death of this young man since health practitioners were advised in July 2021 that it was a risk?  Maybe not.

Informed Consent Must Include Discussion of Risk As Well As Benefit

Doctors were specifically advised in an April 2021 Guidance Statement from the Medical Council of New Zealand (MCNZ) to discuss the benefits of Covid-19 vaccination with patients.  There was no mention of discussing risks, uncertainties or alternatives.  In fact, doctors were threatened with disciplinary action if they provided any ill-defined ‘anti-vaccination messaging’ which could potentially include discussing risks and doctors in NZ have been punished for “encouraging vaccine hesitancy”.  Due to this fact alone, most consumers would not have been fully informed, as many health workers took the MCNZ’s cue. 

It was a pharmacist that gave the young man whose inquest is being held, his vaccine.  The Pharmacy Guidance issued in May 2021 recommended that pharmacists discuss the risks as well as the benefits of vaccination which is an improvement on the guidance doctors and dentists received.  Was it read, was it followed and were other pressures put on pharmacists to vaccinate as many people as possible and not discourage vaccination by disclosing risks?

Would disclosure of risks have made any difference though, as even if people were informed, were they actually in a position to consent freely or to decline consent if their jobs and/or social lives were at stake?  Would Rory Nairn have sought help earlier if he had been warned about the symptoms of myocarditis? It has been noticeable that MOH messaging has sought to blame the man’s death on himself, for delaying seeking treatment. But haven’t we all been told that “musculo-skeletal pain” is a common side effect of no concern. How would he have known the difference?  The couple did call for help, but alas it was too late. 

What is the position now of those who did not freely consent or those who were not given sufficient information and have suffered adverse effects?

Duncan Webb, former dean of law, University of Canterbury, now Chief Government Whip, answered a curly question on RNZ’s Afternoons in 2016 about this very issue of when Informed Consent is inadequate.  The question was:  

“If informed consent for a medical procedure requires that you are fully informed about risks, but the person informing you has a knowledge deficit about those risks, how legal or lawful is that consent?

If you are not fully informed, how can you make an informed decision?

If you then experience one of those non-disclosed risks and become disabled, who is held to account, the person who presumably you trusted knew about the risks, or those who did not inform and keep that person up to date with information required to allow them to do their job and protect you from harm?”

Duncan Webb: “One of the critical questions is what risks are disclosed.  It is not always feasible to disclose every possible risk.  You can only disclose in general terms what the nature of those risks are.  Now if one of the risks does eventuate and it hasn’t been effectively disclosed, then obviously that is grounds for complaint.  And certainly there have been plenty of instances that the HDC has looked at where informed consent hasn’t been given because the risks haven’t been fully and fairly explained.”

It would seem to us that a lot of New Zealanders would have grounds for a complaint to the HDC.  Who will be held accountable for prohibiting doctors from fulfilling their obligations?  Who will be held accountable for the vast majority of New Zealanders not being fully informed??

The risks are not merely academic. As we all ought to know by now if media told the truth, people are dying in excess, but not just shortly following the jab. In fact, data from 3 major jurisdictions – the US, UK and EU – all point to the peak in deaths being 5 months, on average, after the 2nd jab. Complete overseas data regarding the boosters is not in yet but it is looking ugly here in NZ.

Informed consent or uninformed coercion? How breathtakingly obvious does it have to be before people wake from their trances and demand to be informed and compensated?

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