Category: Adverse events (Page 2 of 3)

In October 2004, the Therapeutic Goods Administration (TGA) took the step to remove Vioxx, a non-steroidal anti-inflammatory drug from the Australian market due to safety concerns.

The drug had been used by an estimated 300,000 Australians since it first became available five years earlier. Prior to its release, eight studies with 5400 subjects were undertaken in 1998, followed by a further study of 8000 people in 1999. While noting a higher rate of cardiac events in those taking Vioxx compared to another non-steroidal anti-inflammatory the drug was released to the market as there was not a determination that Vioxx was causative in these events.

Over the next five years a number of studies demonstrate that Vioxx may increase cardiac event risk and the TGA had received a total of 1253 adverse event reports including reports of 48 deaths. Five of the adverse event reports involved young people between ages 1 and 17 although none of these involved death. It was removed from the market. Contrast this with what we are currently seeing reported to the TGA following administration of Covid 'vaccines'.

Covid 'Vaccines'

To date over a nine month period between December 2020 and October 2021, the TGA has received 71,529 adverse event reports related to Covid 'vaccines', including reports of 620 deaths. While the range of serious symptoms that present is very broad, there have been specific concerns expressed about cardiac events, particularly in young people.

Children as young as 12 were able to access vaccination from September 13 2021. Between that date and October 23 there were 9600 total adverse event reports and 83 deaths. Among these reports were 731 cases of pericarditis and 270 of myocarditis, two conditions which are affecting the younger populations.

Among young people 12-17yrs the breakdown of pericarditis and myocarditis is:

In this period of only 41 days, 104 children experienced either pericarditis or myocarditis following a Covid vaccine. These are just the ones that have been reported.

One 14yr old was reported to have had a brain herniation. In the period one death was reported with this symptom and only one report contained this symptom. Whether this 14yr old had an underlying condition is not reported, however it is stated that she had only taken one medication, that is the Spikevax vaccine.

While this article is breaking down only two specific conditions, the range of adverse symptoms in these children were concerning and include menstrual irregularities, chest pain, abnormal ECG findings, thromocytopenia, vomiting, dizziness, pain, lymphadenopathy, pulmonary embolism, Bell's Palsy among many others.

It is of grave concern to me that the general public are not better informed about these serious adverse events among children, particularly as there is consideration to rolling out these drugs to even more vulnerable ages as young as five.

I'm not sure this article by Margaret Somerville could be a more bitterly disappointing and concerning examination of the ethics of mandatory Covid-19 vaccination.  Declaring her prejudice immediately by use of the term 'anti-vaxxers' which has become widely used to denigrate any person choosing not to vaccinate, Somerville identifies any person who for any reason is not vaccinating by this term saying,

"For my purposes here, I include them all within the designation “anti-vaxxers”.

Of course, there can be no legitimate reason for adopting a term of denigration to describe any group of people if your intent is to genuinely and objectively explore the ethics of an issue.  This seems to be lost on Somerville as the term is used no less than nine times, constantly reinforcing the inaccurate and derogatory language that has been adopted in the public sphere.

Deciding there are three groups of people in her 'anti-vaxxer' identifier, Somerville declares the basis for non-vaccination to be:

• Those who oppose all vaccinations
• Those who are 'vaccine hesitant' due to concerns about safety and efficacy or hold a distrust of those promoting the vaccine
• Those who are only against mandatory vaccination

While she correctly identifies some of the reasoning behind those who are taking a stand against mandatory vaccine, Somerville clouds the issue by suggesting that many are also opposing other Covid measures such as masks and lockdowns. She offers no evidence for this although it would be understandable that after 18 months of lockdowns, masks, and loss of jobs, closing businesses, and suffering mental health that people are simply tired of having all of their freedoms lost.

At the same time as she engages in denigration of those choosing not to vaccinate, Somerville fails to do any more than offer the same media propaganda on Covid and vaccine safety and efficacy that we hear all day on television.  While there is certainly some basis in truth that vaccination reduces likelihood of hospitalisation and death for the fully vaccinated person, there is ample evidence that this is achieved for only a relatively short time; in Israel a person is now considered unvaccinated if their last dose was less than six months prior.  It also doesn't account for the fact that those who do become hospitalised or die often do so for the same reasons they would have if they'd not been vaccinated: their age or underlying comorbidities. Nor is any weight given to the alarming and growing evidence of potential short-term harm from vaccines, let alone the long term effects that may not be seen for years.

In the context of these omissions, Somerville goes on to give examples around vaccination that give priority to the importance of safety of those who are vaccinated.  Deciding that a vaccinated worker has the right to be protected from, and therefore not work with an unvaccinated worker, or that an unvaccinated caregiver is a threat to a vaccinated person in their care, she again fails to acknowledge any of the latest research around infection transmission.  There is now evidence that vaccinated people carry similar viral loads when infected as people who are not vaccinated making them as much a risk to others.    While I understand there are many vested interests at play in this information being censored or dismissed, when one is considering ethics, it is prudent to apprise yourself of, and consider all of the possibilities.

Somerville further perpetuates the alarmism of today's politics by talking about overwhelmed hospital systems.  Few people are questioning why our hospitals should be overwhelmed after 18 months of preparation, just as few people question why our healthcare system is often overstretched at any point in time.   Furthermore she makes the disturbing statement,

"I have been musing on whether the “anti-vaxxers” should go to the end of the queue if they need such care, but that would raise other ethical problems and, so far, I have been told, a person’s vaccination status is not being factored in in allocating treatment when there is a shortage."

Disturbing because she then doesn’t go on to denounce the absolute lack of ethics in such a stance, but leaves it hanging as though it might one day be an 'okay' possibility.

Her conclusion?

"If justified mandatory vaccination in precisely defined contexts can effectively address even some of these issues, I propose it is not only ethical, but ethically required. “Justified” means that mandatory vaccination must be the least invasive, least restrictive alternative reasonably available and likely to be effective to achieve the goal of minimising, as far as possible, the spread of COVID-19, and the risks, harms, and consequences that go along with it."

Somerville has not addressed risks of vaccine, nor the individual risks of Covid, nor that the average age of death from Covid in Australia is greater than the average life expectancy. 

Nor has she questioned why treatments that have substantial evidence of efficacy have been banned by the TGA.   Not banned because they don't work but because too many people apparently wanted the treatment and supply was an issue and there were concerns that treatments might stop people vaccinating.

If ever there was an issue to critically examine ethically it would be the banning of less invasive, less restrictive alternatives. Clearly that could be too damning of the political stance all too obviously underpinning this less than objective ethical exploration.

Over the past few short weeks we have seen healthcare workers not just falling from the pedestal of public acclaim, but pushed off and trampled underfoot. From cries of how selfless and brave they are to sacrifice to care for people during the Covid crisis to cries of 'selfish', 'shouldn't be in healthcare' and even 'scum'. The latter directed at healthcare workers who are exercising their human right to refuse a vaccine that has no long term safety data and those who are advocating that every person should have the right to choose freely. Not all of those calling for a stop to mandated vaccination have decided not to vaccinate. There are huge numbers who chose vaccination who still stand for the human right of individuals to choose the medical interventions for their own bodies.

Yesterday this article was published in the Herald Sun with the headline, "Ambo's anti-mandatory jab stance investigated". Paramedic Jessica Davis was named and shamed for the terrible crime of:
"...a series of social media posts in which she criticises the mandatory vax requirement for ambulance workers."

She was quoted as having stated,
“I'm pro vaccine, just under voluntary conditions, that's all,”

“I feel if you make anything voluntary, you'll have more people accepting it, if people are coerced, they back right off. We're going nowhere fast.

“Maybe … they don't want to gamble with a 'rare' adverse reaction. I think that's fair enough and doesn't need to be any further justified.

"Where there is a 'rare' risk there must be choice."

Shocking right? A healthcare worker who has been trained to a high standard of ethical and professional conduct around issues of consent is making statements on social media that she believes the ethics of consent is fundamental to decision making about Covid vaccines.

Hundreds of healthcare workers including paramedics, nurses and doctors who agree with her are then dismissed as 'an unwanted headache in key areas as Victoria moves out of lockdown.'

Jessica will now face potential disciplinary action from AHPRA the health regulatory body that has gagged all healthcare workers from speaking anything that doesn't totally support the government line.. which of course we know can change from day to day.

If she has chosen not to vaccinate she also now faces the loss of her job along with hundreds like her in Victoria from every sector.

When government tells you to talk to your doctor about vaccines as a way to alleviate your concerns it is important that you fully understand what that means. Doctors, like paramedics and any other person whos profession is regulated by AHPRA are not allowed to dissent from government mandated views. They are not allowed to hold an opinion that upholds the highest of ethical standards such as informed consent. They face disciplinary action if they do anything other than tell you to vaccinate regardless of your personal risk factors.

Right now in Victoria thousands of people are being coerced into a medical intervention they don't want or face the loss of their livelihoods. It isn't just the health sector affected but every person who works in a factory, on a construction site or in their own private consulting business. It isn't a matter of being able to just get another job. There are no jobs to move to where vaccination isn't mandated unless you work for a commonwealth department or in the judiciary or parliament.
There is growing evidence that efficacy from current vaccines wanes pretty quickly and people all over the world are already having 'boosters'. Boosters are not new kinds of vaccine as someone suggested to me this week.. believing her booster was the newest and therefore 100% effective against Delta.

In Israel all those considered vaccinated have had that status revoked. If your last jab was more than 6 months ago you join the ranks of the unvaccinated and have your rights restricted.
The frantic rush to buy more vaccines will continue as Australia will inevitably follow this path instead of investing in more effective vaccines and early treatments.

Instead of our focus being on drawing people together, continuing to be proud of those who sacrifice to care for others, our governments have instituted segregation of 'vaxxed' and 'unvaxxed', and created a divisiveness unlike any other in my lifetime.

They are also not just allowing, but encouraging the personal and professional destructino of those who simply want to ask questions, fight for your rights and make choices for themselves.

Alarmist Gatekeeping at its finest and most horrendous.