Safe and effective
In the middle of December 2020, Anthony Fauci leans on a podium set up for the Vice President of the United States. He grasps the podium on both sides and addresses the room full of starstruck reporters. Speaking confidently, his wrinkled smile forms into a grimace as he addresses the two questions that are “asked” by those that are vaccine “hesitant or reluctant”.
“Did you go too quickly?” He asks rhetorically before answering this phantom question, “The answer to that is the speed is a reflection of extraordinary scientific advances and did not compromise safety nor did it compromise scientific integrity.”
Proud of his convincing argument, Fauci moves on to the next question. “Ok”, he imagines his fictional skeptic answering without any follow up questions to his non-answer, “Is it really effective or is this something the government is trying to put over on us? Is this something the companies want to take advantage of?” He answers this question by referencing the clinical trials. These trials, were of course, run by the companies and vetted by the government that he imagines his fictional skeptic is skeptical of. Yet, that does not matter because people volunteered for these trials, which means the products of those trials must, by virtue of effort, be safe and effective.
Fauci is a man that knows all the answers to questions that were never asked. Reductionist questions that demand reductionist answers.
These words, safe and effective, have permeated modern discourse usually to the detriment of rational thinking. We have heard these terms thrown out by doctors, coworkers, corporations, family members, and friends. Context is never offered.
Indeed, one Canadian doctor argues that “Just asking questions is an established misinformation tactic”. We are given a line and told to believe it hook, line, and sinker. Nuance makes for bad actors, you see. Even those doctors that ask questions or offer guidance based on their own experience are investigated by the medical tyrants that be.
However, anyone that has any experience using the scientific method knows that asking questions is literally what provides it with any meaningful power. For this reason, there is no point where asking questions is not a necessary aspect of science. Anyone who tells you otherwise is selling you something.
It is fitting, then, that safe and effective is a marketing tool more than anything else. Every medicine that is approved is labelled safe and effective even those that later get pulled off the market. Even those that do not get pulled off the market but should. But Fauci leads us to believe that safe and effective is an objective measure that can be trusted without understanding what it means and why it is used. He is wrong.
Safe and effective, as far as it can be said to have any merit beyond a marketing gimmick, is completely subjective. Let me explain.
Effective is a function of benefit. To be effective a drug should be shown to have a benefit for the illness it claims to treat and that benefit should can only be projected onto the population for which the drug was tested under specified conditions. One of the reasons why we are seeing so many studies on natural immunity versus vaccinations is because effectiveness has not been proven for those with natural immunity. In any case, there are many ways in which the effectiveness of these vaccines, in particular, should be questioned.
The trials were so poorly run that efficacy has never been concretely proved. Doctors and vaccine enthusiasts claim that effectiveness has been proven in the real world making the problems with the trials moot. Of course, without proving efficacy, effectiveness cannot be proven since efficacy is necessary to prove effectiveness.
As a benefit has not been shown in the first 14 to 21 days, and in fact, the vaccines may do the exact opposite of what they claim to do in that time frame, it makes it difficult to distinguish whether or not there is an overall benefit (what I call, the ‘breakeven point’). In other words, if there is a benefit, say, after 21 days, does it outweigh the loss of effectiveness in the previous 21 days. This may seem likely, but the question of effectiveness is a mathematical equation and an early loss of effectiveness skews that equation. Why? Because if a treatment is not effective early on, but natural immunity is effective, then a treatment that increases the chance for an individual to obtain natural immunity may look more effective by merely exposing an individual to the virus. Letting the virus move through society, as in the Swedish model, was heavily criticized early on in the pandemic.
Does the vaccine weaken the body’s ability to keep natural immunity once acquired? This is a rather new question raised by recent studies (see boriquagato’s excellent analysis). If so, and if any protection raised by the vaccine is temporary, then this vaccine cannot be said to be effective. Natural immunity is the gold standard for this virus and any weakening of the system that allows natural immunity to develop means that on a long enough timeline the effectiveness of the vaccine will necessarily be negative.
If real world effectiveness has been proven, why has the virus not become manageable? We seem to be in a scenario where, despite many having natural immunity already, the virus is at least as bad as it was last year. Natural immunity has not been shown to weaken substantially over time (except when combined with vaccinations… cough). So it is hard to square this circle, and it seems to have been blamed on either the unvaccinated or variants. The problem is people were fully unvaccinated last year, so if the vaccine is even marginally effective, the virus should barely be present in society compared to last year.
If variants are the problem, and they are created by environmental and biological pressures placed on them by the vaccine (which would almost certainly be the case), then can it be said to be effective if it creates a more virulent form of the virus?
There are, of course, more questions on the effectiveness of these vaccines. I personally am unconvinced that we can reliably call it effective. Not having any effectiveness would not be a problem. Sugar pills, for example, are ineffective. The concern is that these vaccines include areas where it actually suppresses the immune response to the virus and creates more virulent variants. Meaning the effectiveness could be negative (again, on a long enough timeline). The exchange, if the vaccines are effective at all, is a medium term benefit.
Safety, on the other hand, is an even more interesting question. Few would argue that chemotherapy is not effective at killing cancer cells. The question is what else does it kill. That is essentially the role that safety plays. Under ideal circumstances, if we were operating according to the Hippocratic Oath, then these vaccines would do no harm. That is the definition of safe that most of us use. But most drugs do not use that definition. Rather, in the world of the FDA, safety is a function of risk.
I do not have any problem with such a characterization of safety, though the nomenclature of the word bears little resemblance to reality (and thus, the regulators should not use the word ‘safe’ at all). There are times when a person may want to take on a risk to gain a certain benefit. For this reason, I am in favor of experimental treatments for certain, especially terminal, illnesses. However, these situations require informed consent. Without informed consent, no medical treatment should ever be given unless the situation is dire and the person is unable to give such consent (ie. a surgery for an incapacitated patient following a car crash). This is not a dire situation where individuals are not able to provide informed consent.
Thus, individuals should be made clear of the risk of vaccinations and allowed to make their own choice. Since everyone has a different tolerance for risk, what is considered a good choice for one person may be a bad choice for another. What is true is that not all the risk factors are known variables in this instance.
There is certainly short term risk that ranges the risk that the vaccine is negatively effective immediately following a vaccine and there are many adverse events. This short term risk is incredibly important to recognize as the effectiveness can be said to be, at best, an unknown level of medium term benefit. Even if the vaccine shares some adverse events with the virus, one has to be informed that there is either a good chance a person has natural immunity already if the virus is incredibly infectious or a good chance a person will not get the virus in the medium term.
The adverse events are almost certainly under-reported. Thus, we do not know what the actual risks to the vaccine are. This should be communicated properly to anyone getting the vaccine, yet it has not been.
Long-term risk is a complete unknown. Anyone suggesting otherwise is lying. Thus, to term a vaccine safe without knowing the long-term risk is criminal.
There is only downside risk to those with natural immunity.
Risks may vary depending on age. For example, young men have a much higher risk of developing myocarditis than other age groups. This happens to be an age group at almost no risk from the virus. Fauci and his acolytes barely make reference to this fact.
Second doses and boosters increase risk every single time and we do not fully know whether they increase risk at an increasing rate.
Much like effectiveness, safety has many more questions that need to be answered (beyond the few I have listed here) before these vaccines can be labelled as safe. Fauci knows this. The FDA knows this. We know this. But do the vaccine enthusiasts know this? Considering how quickly they are to assault, belittle, and threaten anyone that refuses these vaccines, it seems unlikely they understand that ‘safe and effectiveness’ has not actually been sufficiently proven. If Fauci wanted to ease the mind of the refusers, then he would commission independent and robust studies to address the concerns raised here. But he will not because he would not like the results.
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