Informed Consent

Informed Consent

In October 2021, Pennsylvania representative Chris Rabb issued a memorandum in support of a future bill that would make vasectomies compulsory. The procedure would be required either six weeks after a man had his third child, or by his 40th birthday, whichever came first, and a $10,000 reward would be offered for snitches informing on any “scofflaws” who failed to comply. 

Rabb’s proposed “parody legislation” was a theatrical response to Texas bill SB8, which would become the Texas Heartbeat Act. If the law can be used to control women’s bodies, so his thinking ran, then it can just as easily be used to control men’s bodies.

The flaws in his logic are obvious. He equates a law protecting unborn life with a law inhibiting unborn life. A more appropriate analogy to his proposal would be a law that forced women to undergo abortions or tubal ligation—the opposite intention of the Texas legislation Rabb was so worked up about. And American society has no such law.

Yet.

Here’s my first question: what’s the difference between a society that forces abortions or sterilizations on its citizens and a society that doesn’t?

One might be tempted to say it’s that the latter values life and the former does not. But as important a distinction as that is, it’s a line we crossed long ago. We already live in a society in which abortion and sterilization are not only acceptable medical interventions, but are deemed essential to reproductive health.

Setting aside whether abortion or sterilization should exist as medical interventions at all, my second question is: who should decide whether to undergo these medical interventions? The individual? Or someone else? 

The correct answer to my first question is that one society forces certain medical interventions on citizens, while the other allows individuals to make their own medical choices. The answer to my second question should be obvious.

The long established precedent in all Common Law countries is that medical choice is a personal matter. The human person is inviolable. No one else has any right to interfere with a person’s body against that person’s wishes, except in emergency situations where the patient is unconscious or lacks decision-making capacity.

To discard this precedent would be to abandon a principle that is fundamental to human dignity and freedom. It’s a line that ought never to be crossed if a society is to remain free.

And yet, over the past two years, we have crossed it. And most of us didn’t even notice.

Until 2020, the USA, Canada, the UK, Australia, and other Common Law countries were firmly on the side of free and informed consent. As recently as 2015, in a case called Montgomery v Lanarkshire Health Board, the UK Supreme Court said: “An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, & her consent must be obtained before treatment interfering with her bodily integrity is undertaken.” This accords with the decision more than a century earlier in Schloendorff v Society of New York Hospital in 1914: “Every human being of adult years & sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages. This is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained.” There have been many other decisions in the hundred years separating these two that could also be cited to support this position.

This principle would appear to be violated by mandatory vaccination policies in schools that have been around for decades, as well as vaccine requirements for Green Card applicants, but self-certified exemptions have always been widely permitted, preserving the individual’s right to refuse medical treatment. 

If an individual (or the parent of a child) has a sincere moral or religious objection, the law has always given that priority over such vaccination requirements, just as it would for a medical contraindication. The First Amendment gives this respect for personal belief an even more solid basis in the USA than in other Common Law countries. 

But even if the objection isn’t moral or religious, but practical, preferential, or based on a risk assessment, a clinical exemption should be available to anyone who objects to any medical intervention for any reason at all, because free and informed consent is a prerequisite for any such intervention. In other words, if a doctor or nurse does not obtain the patient’s consent, they cannot proceed. Without that consent, the patient has not met the requisite conditions to undergo the medical intervention and therefore the patient is clinically exempt from that intervention. If the intervention proceeds without that consent, or if that consent is coerced in any way, or if relevant information is withheld, the party responsible is at minimum liable for the tort of battery.

This is still the law as it stands. However, a law is only effective if it’s observed and enforced.

Although politicians occasionally pay lip service to these exemptions, they have become extremely difficult to obtain in practice. The mere fact that some requests for medical or religious exemptions to recently imposed Covid-19 vaccine requirements have been denied is proof that the principle of informed consent is in serious jeopardy. So much for the First Amendment and the right to patient autonomy.

Here’s another question: are there certain conditions in which the state can legitimately override this medical autonomy, and enforce medical intervention without permitting any exemptions, religious or medical?

If there were any such legitimate scenario, it must be clearly defined in law, with a high burden of proof put on the state to justify both the necessity and efficacy of a proposed intervention. Such a displacement of fundamental liberty must be approached with trepidation, however, because If the state can override the individual’s choice in any circumstances, however narrow, personal medical autonomy, and liberty along with it, is in danger of being destroyed. Once we go down that road, we risk setting a new precedent that the state need only create those narrow circumstances in order to suppress medical freedom, and further, we open the possibility that the government might alter the law over time to include other, broader circumstances. It’s a slippery slope. That is why it’s so important to adhere to the principle that all medical care must require the consent of the patient.

Yet despite the many protections of personal liberty enshrined in law in the US, the UK, Canada, Australia and New Zealand, none of them, not even the First Amendment, have proved unassailable over the course of the lingering coronavirus pandemic. Governments imposed unprecedented restrictions to personal liberty using the seriousness of the threat we faced as justification, and one of the main casualties was the principle of informed consent. But it isn’t enough that all our governments say that there’s a crisis. They must prove it, and a closer look at the evidence reveals the flimsiness of that justification.

Instead of insisting upon a high threshold of evidence to show that the virus was as deadly as early worst case scenario models predicted, our governments just accepted the models, such as those out of Imperial College London, which predicted 2.2 million deaths in 2020 in the USA alone, as if they were scientific proof. These models were based on several false assumptions that were known to be false at the time: everyone was equally at risk, there was no pre-existing immunity, and asymptomatic spread was a major driver of the pandemic. 

Models are the weakest form of scientific evidence and can never reach the threshold that ought to be necessary to justify the suppression of liberty that ensued.

Then, instead of insisting on a high threshold of evidence to prove that proposed restrictions to liberty, collectively known as “lockdown”, would be effective, and on balance, more beneficial than harmful to society in dealing with that demonstrably justified threat—in other words, conducting a cost-benefit analysis—governments implemented restrictions as if the precautionary principle were all that mattered. The effects on liberty (not to mention the many other negative side effects of lockdown restrictions) were evidently not worthy of consideration. 

Three intrusions on the precedent of personal autonomy in medical decisions followed.

Testing

The first of these was asymptomatic testing. A PCR test is a medical intervention involving inserting an instrument (a swab) in the nose and mouth of the patient. It is invasive and must require the free and informed consent of the individual. At first this fact was respected, but testing increasingly became a requirement to go about normal life—to travel, to work, etc. Some people were required to test daily just to continue to make a living. The burden of proof shifted from the government having to justify the need for mass testing to the people having to prove they weren’t infected. In this new paradigm you’re sick until proven healthy.

But the PCR test was never meant for testing a healthy population. It was intended to be a confirmatory test following a clinical diagnosis of symptoms. A “case” of Covid-19, properly speaking, means a symptomatic diagnosis of disease in a clinical setting, followed by a PCR test to verify the presence of the specific pathogen. But that definition has long been abandoned, so that now in common usage, a “case” means nothing more than a detection of a fragment of RNA of SARS-CoV-2. The “case” counts used to justify continued restriction do not refer to instances of disease in hospital but to detections of viral fragments in the population. This means the numbers are far higher than they ought to be, painting a picture of a crisis that isn’t really there.

The arrogance of certain medical professionals who thought they could control the movement of a microscopic virus at any cost to society required a method of testing the population to determine how much the virus was spreading. But this wasn’t actually possible. For one thing, many people would get tested frequently, while others wouldn’t get tested at all. Secondly, the PCR test is very sensitive, but cannot detect viral infection or infectiousness. And since it only detects fragments of the virus, it can pick up dead viral particles, and a person might continue to test positive months after recovering from an infection. 

The push for asymptomatic testing was based on the assumption that the virus can spread asymptomatically—a claim for which there’s very little evidence. Dr Jay Bhattacharya, professor of medicine at Stanford University testified in a Canadian court in April 2021 that, based on the medical data, asymptomatic individuals are less likely to spread the virus than symptomatic individuals by an order of magnitude. This particular virus spreads through the air which means that if the virus is present in an individual the viral load must be coughed or sneezed out into the air to spread to others. No coughing or sneezing means the virus is not likely to travel anywhere.

The scary numbers that resulted from mass testing, although they ensured the continuation of restrictions, were of little use to the stated aim. Infected people who didn’t get tested went about their business, while non-infected people who tested positive self-isolated unnecessarily. If the goal was to prevent people getting sick a much better approach would have been the old-fashioned advice to stay home if you’re not feeling well. 

But many people just did what they were told. Once testing became widespread, it became mandatory for certain activities, especially travel. It’s one thing for a country to have rules for foreigners to enter, as they do not have any legal right to entry, but quite another for a country to enforce medical procedures on its own citizens in order to come home. 

Masks

The second intrusion was compulsory mask-wearing.

For months the medical experts told us that cloth face coverings were ineffective and counterproductive, and advised against their use by the general population. 

The WHO changed its guidance in the summer of 2020 “due to political lobbying”, according to a report by the BBC’s Deborah Cohen. She added that the WHO did not deny this when asked. Without any change in scientific evidence, this change in guidance soon led to mask mandates all over the world.

The governments that had implemented harsh lockdowns were committed to that draconian strategy, and they had to ensure continued compliance from the public. Whatever else they might be, masks are a low-cost instrument of propaganda. They are a constant reminder of the threat, and yet they provide a false sense of safety and virtue to wearers. But governments claim that they’re for our health and safety. Masks, like testing, are therefore a medical intervention, and, as such, require informed consent.

The assertion that mask-wearing would protect a populace from a virus was at best, an unsubstantiated belief. Many people point to various studies to argue that masks are effective, but while an observational study might show how masks work, only a randomized controlled trial can show that they work as claimed by governments. The findings of observational studies are limited to the narrow conditions under which they are conducted, and the existing studies on masks contradict each other.

Randomized controlled trials (RCTs) are the best tool we have to prove a scientific claim, while accounting for confounding factors, known or unknown. They are the only type of scientific study that constitutes conclusive proof. Virtually all RCTs ever performed on the wearing of face coverings by a populace have shown that there is no statistically significant difference in viral spread between those who wear masks and those who don’t. The first RCT performed on mask-wearing and SARS-CoV-2, specifically, was published in November 2020. The Danish study, which struggled to find a publisher, involved over 6000 participants, and found, once again, no statistically significant difference. This was conclusive proof that masks were ineffective and should have ended mandatory mask-wearing everywhere, if these decisions were guided by evidence. 

Governments didn’t provide the necessary threshold of evidence to justify forcing a hitherto unmasked society to mask up because that evidence didn’t exist. But they did it anyway, and since then, people without masks, regardless whether they claimed a medical exemption, have been discriminated against, ostracized, and insulted for exercising their right to personal medical autonomy. Once again the burden of proof shifted from those who wanted to mask us to justify themselves, to those who wouldn’t or couldn’t wear a mask to prove why they dared show their faces in public.

Among these are people who suffer from anxiety, asthma, or autism, pregnant women, and rape victims who suffer from PTSD when their mouths are covered. But legitimate exemptions should also extend to anyone who for any reason doesn’t consent to wearing a face covering. 

Masks, like testing, may not pose much danger to physical health in most cases, but the effects on mental health and social interaction, especially to children, are more serious. What are the long term consequences of masking our children in school daily for two years? What about the effect on the development of infants who can’t see their parents’ and caregivers’ faces? What about deaf people who can no longer read lips in public? 

Vaccines

Asymptomatic testing requirements and mask mandates paved the way for the third intrusion on personal medical autonomy: vaccine requirements. These are clearly a more serious kind of intervention, because vaccines require an injection into one’s body. Like testing, they are invasive, but they go further, leaving a pharmaceutical product behind. Vaccination is not reversible.

Without consent, inserting something into another person’s body is nothing short of medical rape. 

Not only should no one be forced or coerced to be injected with a piece of technology, but their freely made, informed decision ought to remain a private and personal one. It’s nobody else’s business.

It is widely known by now that vaccines do not prevent the spread of the virus. At best, they reduce severity of symptoms, and may prevent hospitalization and death in some people. Vaccinated and unvaccinated alike can catch and spread SARS-CoV-2. 

On top of this the rushed vaccines have caused a significant number of negative side effects, according to both VAERS (Vaccine Adverse Event Reporting System) and the UK’s Yellow Card reporting system. Reports of blood clots, heart inflammation, miscarriages, mentrual cycle irregularities, and other side effects are increasingly common. Thousands of deaths have been reported. 

Government and media will retort that the vaccines are safe and effective and that these are just reports that cannot be causally linked to the vaccine. But once again, the burden of proof is shifting from those who insist we get vaccinated to those who question the need for vaccination. 

When it comes to a drug, the burden of proof is always on the pharmaceutical company and any other promoters of that drug to demonstrate that it is safe. It has always been the case that a drug is considered dangerous until proven safe. This has now been reversed and the “vaccine hesitant” are forced to prove their exemption status or comply. Many unvaccinated people are being penalized for what ought to be a free and private medical decision. Many have lost their jobs.

Surely a risk assessment is in order. A patient must be fully informed of the risks of the virus and the risks of the vaccine, including all known side effects, and all gaps in knowledge of safety, before making a decision. But none of the available vaccines underwent proper safety trials. Pfizer stopped its phase 3 trial early and offered everyone in the control group the vaccine, ensuring the trial would never be completed. Long term effects are totally unknown. Is informed consent even possible under these circumstances?

It doesn’t matter whether an individual can prove that either asymptomatic testing, mask wearing, or the vaccine are ineffective, unjustified or dangerous. The burden of proof isn’t on the individual. For most of our lives we didn’t do these things. We could choose to, of course. For an individual freely to choose to undergo any of these interventions, knowing as far as possible the risks and the benefits, is entirely acceptable. But if the government wants to force us to undergo these interventions, it shoulders the burden of proof to justify overriding fundamental freedoms once considered sacred. 

But the state has compelled or coerced us into undergoing all three of these, by limiting what work we can do, what establishments we can visit, where we can travel, and who we can visit, as a penalty for exercising our right to patient autonomy. The government is discriminating against a minority group for their health decisions, without any strong justification. It’s clear that we have set a new precedent—that governments need only cry “crisis” and then impose interventions to deal with the crisis without anything approaching proof, and our right to medical privacy, informed consent, and bodily autonomy is displaced.

What might they do with this new precedent?

The Climate Crisis

The rhetoric used by public figures speaking about climate change is increasingly bellicose. “Code red” is how President Biden described the threat posed by climate change in September 2021. He promised “the largest effort to combat climate change in American history.” Prince Charles recently said “we have to put ourselves on what might be called a war-like footing” to fight climate change. 

Like Covid-19, climate change is an issue on which many scientists disagree, but on which the government and media seem unwilling to permit any dissent from their fear-mongering narrative. The evidence of the threat is again largely based on the lowest form of scientific evidence: models. 

Mark Carney, former Governor of the Banks of Canada and England, and currently UN Special Envoy on Climate Action and Finance, recently published a book called Value(s): Building a Better World for All, in which he said that restrictions on liberty would be required to deal with the climate crisis. (This may prove to be more than just words, as Carney looks to be angling toward a political future in Canada.)

There have been many news stories over the past year of forthcoming “climate lockdowns”. And now that lockdowns have become the default reaction to crises, it’s more than just a remote possibility. These climate lockdowns would include things like limits on personal vehicle use, restrictions on red meat consumption, and enforced reductions in energy use. But will it stop there?

Overpopulation is frequently identified as one of the biggest problems contributing to climate change. There’s a growing trend among young people who pledge never to have children because of climate change fears. UK-based charity Population Matters, which exists to promote sustainable population, gave Prince Harry and Megan Markle an award for their stated commitment to have no more than two children. In 2020, a similar group called World Population Balance launched an ad campaign in a number of North American cities, encouraging couples to have a maximum of one child. For climate crusaders, having fewer children is virtuous.

Is it so farfetched to imagine government measures to keep the population down to save the climate? On the contrary, it almost seems inevitable. There probably won’t be mandates at first. More likely there will be incentives for men and women to get sterilized, after two or three children. Then there might be penalties for those who have more than two or three children—a climate tax on large families.

Those of us who value the family will protest at the injustice of it, but we should be mindful of how we allowed the precedent to be set that permitted this injustice during the Covid-19 pandemic. In any case, our protestations will be ignored and suppressed, our voices censored, our information declared disinformation. Just as governments and media are dismissing the “anti-vaxers” and “anti-maskers” as dangerous anti-science lunatics now, they’ll be dismissing the “anti-abortion climate deniers” as dangerous anti-science lunatics then. 

The state will scapegoat the minority of crazy pro-lifers putting everyone else at risk by their reckless procreation, just as they’re scapegoating the minority of unvaccinated people today, who are supposedly putting the vaccinated at risk. “Pro-choice” will become an obselete term.

This isn’t far away; it’s just around the corner.

It might be argued that this is not a fair comparison because testing, masks, and vaccines are not intrinsically evil, whereas abortion and sterilization are. But that misses the point. Our society is in violent disagreement on which of these are evil. A large proportion of the population thinks vaccination is intrinsically evil. Even sterilization divides opinions among people who consider themselves to be pro-life. Some have no problem with it; others consider it morally wrong. The real issue here is who decides. And it will be whoever happens to be running the government at the time, aided by the media, and armed with the new authority to impose restrictions on personal liberty and medical autonomy. 

Many are fooled into falling for the Hegelian dialectic that sees masks and testing as a lesser evil, and accepts them in order to avoid the vaccine. But as I’ve argued, all three of these violate informed consent, and negotiating with coercion will never end well. If we capitulate and get vaccinated due to coercion, we all lose. If we mask up and test in order to avoid getting vaccinated, we still all lose. In the dystopia I’m suggesting, would we accept early sterilization or proof of contraception as an alternative to compulsory abortion?

Medical freedom must be our unifying principle, because when informed consent is no longer a pillar of our society, we are no longer free. Medical technology becomes something we are forced to accept, despite the fact that iatrogenesis (medical error) is one of the leading causes of death in America, causing approximately 250,000 deaths annually. We must stand up for medical autonomy and free and informed consent now, by refusing to undergo any medical intervention for any reason other than our own freely-made decisions, and by pressuring our elected representatives, clergy, and media to start speaking out in defense of our freedoms. 

If we don’t, future laws requiring sterilization or abortion will be more than parody legislation.

Written by
Andrew Mahon

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