Gavin Newsom Eradicates Informed Consent
By Mandating Covid Shots for Kids Before Approval, Parents Never Get a Choice in the Matter.
I’ve made my opinion of the Covid Vaccines for children very clear. Since healthy kids are at an imperceptibly small risk from Covid, since the vaccines are non-sterilizing and don’t stop one from catching or spreading the virus, and since the risks from adverse side effects are real and not at all clearly lesser than the benefits of vaccination, I see no compelling reason my healthy children need the vaccine at all.
Yet, as I suspected, blue state governors would feel compelled to flex their vaccine bonafides by mandating these vaccines for children. Sure enough, California Governor Gavin Newsom, fresh off his recall victory, has done just that:
Based on Newsom’s decree, California will require all students in K-12 school to be vaccinated, and this mandate will kick in as soon as the shots receive full FDA approval. It’s unbelievable how perverse this move is!
Currently, parents of children under the age of 12 have no option for Covid vaccination. Even severely immunocompromised children, who may benefit from the shot, aren’t allowed to get it due to the FDA, which is still reviewing the data for that age group. It is expected by the end of the month or so the FDA will issue an Emergency User Authorization for 5 to 11 year olds, at which point parents will briefly have a choice. But the whiplash will come as soon as Pfizer dots the I’s and crosses the T’s, and the FDA gets around to full approval of the shot, at which point Newsom’s mandate will activate. Effectively, parents have no say in the matter at any point. First the government says no you CAN’T get the shot, then the government says yes you MUST.
This flies in the face of Informed Consent, one of the bedrock principles of ethical public health.
As the American Medical Association explains:
“Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.”
Informed Consent is vital to patients receiving the care they need, and just as important, in building and maintaining trust in the medical system. Patients have the right to understand the implications and alternatives to a given treatment, and to have the ultimate say in what treatments they undergo. This principle of bodily autonomy can be traced back to ancient society, but even in the modern day where the intricacies of advanced medical technology can make a layman’s eyes glaze over, doctors have an ethical obligation to provide their patients with adequate information to allow them to make informed decisions and the have the final say.
The trust gained through informed consent should not be discounted. Allowing patients to have personal ownership over their health leads to better outcomes, which fosters confidence in the public health system at large. Contrarily, hiding information from patients and leading them or forcing them into treatments they may not need or want is a surefire recipe to create skepticism of the entire public health system.
Trust is hard to build and easy to lose.
You can see that with the handling of the Covid vaccines today where immense public pressure and even the force of government are being directed to force hesitant individuals into taking the shot against their preference, and the result has been a large public outcry in opposition to the vaccine unlike any of the fringe “anti-vax” moments of the past.
FDA Approval plays an important role in the process of maintaining informed consent. Through the drug approval process the FDA certifies that a drug “is determined to provide benefits that outweigh its known and potential risks for the intended population.” This gates off riskier and experimental drugs from patients and informs both doctor and patient on potential side effects to look out for. Patients are then able to use this information, with the assistance of their doctors, to make informed medical decisions.
If anything this process can be too strict. The advancement of “Right to Try” legislation seeks to give more patients access to drugs which have yet to gain approval. Similarly, many voices, including myself, were critical of the FDA’s decision to pause the J&J vaccine for all age groups during the spring. While a pause made sense for younger lower risk age groups it made little sense for the elderly. The key here is that FDA approval is intended to be a process that helps patients in making the best decisions for their own health. When it instead hinders patients the process is flawed.
What the FDA approval process was never intended to be was a green light for mandates. Just because the risks may outweigh the benefits on a population level, does not mean that for each individual, with their unique health histories and distinctive risk tolerances, it will be right for each patient. Optimally, patients are given maximal information and allowed to make the best choice based on their personal situation.
Applied to vaccines, they should spend a lengthy period post approval before they are ever mandated. During this time only those giving informed consent would take the vaccine. As uptake builds through the population, and assuming the actual risk-benefit of the drug is highly favorable, this will build trust in the vaccine. This also allows time for further study to root out any unforeseen adverse reactions. Only then, with high public trust and a spotless safety record, would mandatory vaccination be sought.
This is certainly what we’ve seen in the state of California’s vaccine schedule up to this point. The vaccines mandated for school children all had lengthy post approval periods of on average over a decade prior to being added to the mandatory vaccine schedule for school children. Furthermore in California, and all 50 states for that matter, the mandates are soft mandates, which can be avoided with little more than a doctor's note. This acts as a pressure relief valve and provides those most adamant to avoid vaccination a means to do so without sowing doubt and resentment in the population at large.
Now compare this to Newsom’s current regime where mandates take effect as soon as a drug gains approval. There’s literally no point at which parents have any choice or any say in the matter. It’s simply a matter of whether a government bureaucracy believes that for children in general the vaccine has a positive benefit to risk ratio. If the government says your kid can get the shot, they have to get the shot. Parents are no longer a part of the process, whether they consent or not.
This eradicates all informed consent, and with it a lot of public trust in the process. Given the immense political pressure the FDA is currently under to approve these vaccines for children, and with so much now riding on that decision, can the public trust that their decision will truly be based on simply the risk-benefit outcomes for the child? And why would our government seek to eliminate parental choice in the first place?
Predating the pandemic, there has been a growing faction without public health circles that believes informed consent needs to be set aside. As this line of thinking goes, public health is a public good, and our focus should shift away from individuals to the public at large. “An adequate ethics of public health needs to set aside debates about informed consent and to consider the permissible limits of just compulsion for various types of public good”, as the thinking goes. But look where has this taken us now?
It appears the true motivation behind our Public Health Betters push to approve Covid vaccination for children isn’t based on any risk-benefit calculation for the children at all. Pfizer’s 5-11 application is based on 2,000 dosed children and finds no benefit. How could it? With Covid such a minor risk to children you’d need a trial 100 times that size to find any potential benefit. The motivation then is to use your child as chattel, a tool in their unending, futile quest to end the pandemic.
This drive for universal vaccination is occurring even as more and more information has come out this fall showing that the vaccines do not prevent infection or spread beyond the short term, and as more and more countries contemplate reducing or eliminating child vaccination altogether due to a lack of clearly positive benefit to risk. But instead of adjusting their priors, our leaders haven’t flinched from their belief that universal vaccination will end the pandemic, and they see our children as nothing more than an obstacle to that goal.
As Fauci states:
“In the context of a pandemic… you have to give up your individual rights…”
Our society would be better served by a public health framework that respects the rights of its citizens. Instead of mandates and obfuscation we should be informing parents of the benefits of vaccination for their children and giving them clear and honest information of the actual risks Covid poses to children. And then, we should leave the ultimate choice to the parents.
Unfortunately, in California, Gavin Newsom won’t let parents have that choice.
Anyway 0 and 2…