Understanding the Rules of the Game

Sorry this is such a long post, but I couldn’t justify breaking into two parts. Just a warning, reading further will challenge some very strongly held beliefs, and may be quite upsetting for reasons that will become quickly apparent. If you aren’t ready to have this aspect of your world turned upside down, you might want to stop here.

In order to have a chance greater than pure luck at succeeding in most types of games, you need to understand the rules. Clearly defined rules create an even playing field so opposing participants theoretically have the same opportunity to win or lose. Sports, board games, poker, blackjack, etc. have rules that players must abide by to participate.

Life itself is similar to a game in many ways which is why it’s often referred to as the game of life, and there are rules that have been established by most societies. These rules are in place so that we know what we can and can’t do as an individual or an entity such as a business.

However, what if our understanding of the rules is based on incorrect assumptions because we haven't taken time to fully learn the rules?

What if the actual rules are only known to one side? And what if the referees understand the rules too, but neither they nor the other side take the time to explain the rules of the game?

The party that does not truly understand the rules is at a significant disadvantage.

For example, many people think that ultra wealthy people cheat to achieve their level of financial success. While some of these people do cheat, the reality is most of the ultra wealthy simply understand the rules better than most other people.

The tax code, put in place by our duly elected representatives, is set of rules. While some of these rules benefit the wealthy more, most of us just don’t understand the rules very well, and nobody takes the time to educate us.

This is a different topic for a different day perhaps, but instead of looking at the tax code as a set of penalties, think about it as a set of incentives. What are the incentives and how can you take advantage?

There is another area of life in which the rules of the game are very well understood by a relatively small group, but are not understood by the majority of the people including the people we count on to understand these rules.

As you read further, your first inclination may be to dismiss outright what I’m writing which would be understandable. You may try to come up with reasons why this can’t be true or perhaps something is missing.

The scope of potential deceit is so large that most people can’t even entertain the idea that this is true, but don’t forget the concept of the Big Lie. As I do in most of my posts, I will provide links to legitimate references so you can verify this information yourself.

To be clear, I am not giving advice or making any recommendations. I am not an expert. I am merely sharing information so that you can better understand the rules of the game. How you choose to play once you know the rules is completely up to you.

Much of the information I initially discovered on this comes from a book called “Turtles All The Way Down” and it filled in some of the missing pieces for me. It’s a strange title, but the meaning becomes apparent early on. This heavily referenced book sent me down some rabbit holes of my own which I will share as well. Let's buckle up and jump in.

Medical research is not what it seems

We are told that vaccines, childhood vaccines in particular, are some of the most heavily tested interventions in the world of medicine, and therefore are not only highly effective, but are also incredibly safe otherwise they would not be on the market. Well, except the COVID shots perhaps.

Vaccines have indeed been tested substantially, but historically, medical products were not tested on children because people wanted to protect them from the potential harms of medical research. As a result, no one had any idea what impact a medication or vaccine would have on a child.

That began to change in the late 1970s because it was determined that it was unethical to prescribe a treatment to a population which had not received testing for that medication or vaccine. Let that sink in for just a moment. Essentially, up until this time, children were prescribed medicines and vaccines that were usually not tested in children to determine effectiveness or safety.

So, a set of ethical standards was developed to involve children in medical research. The potential benefits of an intervention must be weighed against the potential dangers. If the participants of the trial cannot be expected to benefit from the intervention, then the inherent risk of the intervention must be minimal.

There must be prior knowledge of the level of inherent risk of the intervention. If that risk is unknown, it cannot be determined to be a minor increase over minimal risk.

Sounds great that these standards have been developed. So how are vaccines for children tested?

RCTs

Under the rules of this game as many of us think we understand them for Phase 3 trials which are necessary to gain approval, vaccines are tested against a placebo in double-blind, randomized control trials (RCT), the “gold standard” for testing medical interventions. Yet, that is not exactly how it works.

For a newer generation of an existing vaccine, the control group receives the predecessor vaccine because it is considered unethical to not give the control group an already approved intervention. Never mind that vaccines are given to healthy kids as a preventative measure which is not the same as withholding an approved cancer treatment from the control arm for a new experimental cancer drug.

For a new pediatric vaccine that does not have a predecessor, the control group should receive a placebo as there is no existing alternative. But even if there was some older generation of a vaccine, you would still need to compare a newer generation vaccine against a true placebo as well.

The following language from the Pediarix package insert is included in most if not all package inserts for vaccines:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice.

Placebos? We don’t need no stinking placebos.

Because there are risks to any intervention, a background or base rate of adverse events needs to be established as a comparator to the rate of adverse events of the experimental intervention arm of the trial. A placebo is used to establish the absolute base rate of adverse events and effectiveness of the intervention, as well as, maintain blinding so researchers and participants don’t know whether or not they received the experimental treatment.

In these trials, we are trying to determine if the intervention causes more harm than benefit compared to no intervention.

But what if a placebo is not what one might think?

When most people hear the term placebo, they think of some relatively neutral product such as a sugar pill, or a saline injection in the case of an injectable intervention. But in regard to childhood vaccines, new vaccines are never tested against a placebo.

The control group for an entirely new vaccine will receive an already approved vaccine that is for a completely different disease that won’t impact the specific antibody levels being measured for the new vaccine. Another control option is to use a compound that is very similar to the experimental vaccine. For example, researchers often use the adjuvant solution minus the experimental antigen, this is called vaccine sans antigen.

Thimerosal, a mercury-based preservative, was used in vaccines up until the early 2000s. How insane is it that we injected an incredibly toxic chemical into anybody much less infants and children for decades? Even though it is supposedly safe and doesn’t cause any problems, it was replaced by other adjuvants such as aluminum in most vaccines.

We are told that the aluminum adjuvant is safe, but it has never been tested on humans. The aluminum “safety” tests were conducted on mice which were fed aluminum in far lower amounts that what a child will be injected with over their childhoods.

The obvious problem here is that neither a different vaccine nor the vaccine sans antigen is biologically inactive, and safety profiles have never been determined. The term “placebo” is grossly misrepresented in testing vaccines, yet is completely legal and approved by licensing authorities.

The shocking reality is that we have no idea of the true effectiveness, and more importantly the safety, of any vaccine for children that has been or is currently on the market because they have never been tested against an inert placebo.

In addition, most trials involving children only have a few hundred to a few thousand participants which is too small to accurately generate a safety signal even if they used real placebos, and these studies are typically quite short in duration.

Ironically, as piss poor as the trials were for the COVID shots, they stand head and shoulders above the trials for the vaccines on the childhood immunization schedule.

The claim that these products are safe and effective are based on assumptions that aren’t based on a foundation of sand, rather they are based on a foundation of air. As the book states, “It’s turtles all the way down.”

I won’t cover all of the childhood vaccines, but let’s take a look at several of them. You can pick up the book if you want to dive in to the whole story.

DTaP

Diptheria-Tetanus-acellular-Pertussis vaccines are administered in combination with or without inactivated Polio, Hib, and hepatitis B components depending on the manufacturer. Pediarix is a 5-in-1 DTaP vaccine that also protects against polio and hepatitis B. Kinrix is a 4-in-1 that does the same as Pediarix minus the hepatitis B component. Pentacel includes polio and Hib components and Quadracel includes polio protection.

The original DTP vaccine caused serious side effects in infants and was replaced by the DTaP vaccines in the 1990s. The original DTP product was never tested in a modern RCT that involved placebos.

According to the package insert for Pediarix, a GSK product, the clinical trial was a three-arm trial where it was administered concomitantly (at the same time) with Hib conjugate vaccine and a pneumococcal conjugate vaccine. The 2nd arm of the trial received Infanrix, which is an older DTaP product from GSK, along with Engerix-B which is a hepatitis B vaccine, and IPV, a polio vaccine, concomitantly with the same Hib and pneumoccocal vaccines. The third arm received Pediarix with the same Hib and pneumococcal vaccines but the pneumococcal vaccine was staggered.

Kinrix, another GSK product, was also tested against Infanrix and IPV. Participants also received MMR vaccines concomitantly in one study. In a second study, Kinrix was administered with MMR vaccines and compared to a group receiving MMR and varicella vaccines.

Sanofi’s DTaP products have similar clinical studies.

Infanrix, the older generation DTaP vaccine was assessed in two clinical studies. One was conducted in Italy with participants in the treatment arm receiving Infanrix and the comparator arm receiving Diptheria and Tetanus Toxoids (DT). The second study had no control group.

Just for grins, I did a search on clinicaltrials.gov for Phase 3 studies in which a DTaP vaccine is the treatment intervention or was administered concomitantly to children from birth to 17 years to evaluate diphtheria, pertussis, and/or tetanus which you can find here. None of the 46 studies that matched the search criteria involved a placebo. Not even the placebos that aren’t placebos.

Haemophilus Influenzae Type B (Hib)

None of the Hib vaccines (Hiberix, ActHIB, PedvaxHIB) were tested in RCTs against placebos. Merck’s product, PedvaxHIB, states that the control group received a placebo, but each study participant also received DTP and oral polio vaccines concomitantly which obviously renders the placebo moot.

Prevnar

Prevnar vaccines protect against pneumococcus bacterium. The current version of this vaccine approved for children is Prevnar-13 which replaced the original Prevnar. For children, Prevnar-13 was tested against Prevnar as the control group. In clinical trials for Prevnar, the control group received other vaccines.

Hepatitis B

First, why on God’s green earth are we giving infants hepatitis B vaccines. Hepatitis B is contracted through sexual contact, sharing needles, or accidental needle sticks. So if you are a prostitute, a drug addict, or a medical worker you are at much higher risk of contracting hepatitis B.

While mothers can pass it on to babies during childbirth, the mothers are tested in advance so maybe it makes sense to vaccinate the children of mothers who are infected with hepatitis B. Outside of that scenario, I can’t see any justification whatsoever for this vaccination being administered to every child.

Engerix B is a GSK hepatitis B vaccine and according to the package insert, no clinical trials had control groups that received anything other than the vaccine itself. Twinrix is a combo hep. B and A vaccine and is only approved for people 18 years and older. None of the studies listed in the package insert had neutral, placebo-controlled groups.

Recombivax-HB is another hepatitis B vaccine and is approved for people of all ages. Again, none of the studies listed in the package insert were randomized, placebo-controlled trials. Another quick review of clincicaltrials.gov for these vaccines does not reveal any true randomized, placebo-controlled trials.

Human Papillomavirus (HPV)

HPV vaccines were not included in the book, but I was curious to see how clinical trials were done for these vaccines. Three vaccines are currently licensed for HPV: Gardasil, Gardasil 9, and Cevarix. Since 2016, Gardasil 9 is the only HPV vaccine currently used in the United States.

According to the package insert for Gardasil 9, the studies compared Gardasil 9 to participants receiving Gardasil. Gardasil was assessed in 6 AAHS-controlled, double-blind, randomized Phase 2 and 3 studies. What does AAHS-controlled mean?

AAHS is amorphorous aluminum hydroxyphosphate sulfate. This is the aluminum adjuvant solution in which the antigen is normally contained. As a reminder, injecting aluminum has never been tested for safety in humans.

I also did a search for HPV vaccines on clinicaltrials.gov which you can find here. Out of the 60 studies that examined HPV vaccines, 19 claimed to have placebo groups. Upon further examination however, only one very small study specifically called out a saline placebo, and the placebo group of about 320 participants was half the size of the treatment group. Under-powered studies such as this one conceal a true background rate of adverse events because of their size.

The rest of the trials that claimed placebo controls received either the adjuvant solution, another vaccine, or an unspecified placebo which means it could be anything.

Influenza

What about the good old flu shot? Surely that has been tested against a placebo for kids.

In a previous post on flu shot efficacy, I highlighted a study that evaluated the efficacy of a quadrivalent flu vaccine for children. In that post, I made a mistake which has since been corrected.

The children being tested received either the test vaccine or a meningococcal vaccine. But I also wrote that children 2 to 9 years of age who had not received a previous influenza vaccination received a second dose of the vaccine on day 29 compared to children who received 2 doses of placebo.

In fact, the previously unvaccinated children from 2 to 9 years of age who were in the control group received the placebo only on the second shot 29 days after they received the meningococcal vaccine. The placebo in this case is irrelevant.

Why?

In the post about flu shot efficacy, I asked why are they comparing a flu vaccine to a meningococcal vaccine instead of a biologically inactive placebo such as a saline injection. One obvious answer is that the efficacy of the flu shot will look great compared to a meningococcal vaccine which is for an entirely different pathogen.

But the real reason why neutral placebos are not used in studies involving children is that they do not want to know what the true rates of adverse events are for these products. By comparing the test vaccine to another vaccine or an adjuvant solution which could very well be more harmful than the antigen itself, they are covering up the actual rates of adverse events.

They are in effect hiding this data, albeit legally, in order to avoid finding out if these vaccines are dangerous. They can legitimately say, “We do not see an increased rate of adverse events in the treatment group over the background rate of the control group.” It doesn’t matter that they have no idea what the actual background rate of adverse events is for groups receiving a placebo.

How this is acceptable to anyone is beyond me. Not only are children being used as guinea pigs during the trials, children continue to be guinea pigs once the product has been approved as safe and effective when no such data exists.

If you’ve made it to this point, you now know more than your doctor when it comes to the vaccination game. I would imagine if you bring this to their attention, they will want to dismiss this as anti-vaxxer propaganda. But ask them if they have read the package inserts, specifically the sections pertaining to the clinical trials. Ask them how much time they’ve spent reviewing trials on cliniclatrials.gov. Ask them to provide you with studies in which the vaccines were tested against saline placebos.

Perhaps you are still not convinced that this data does not exist. Or, you may think “I’ve never had any problems from vaccinations and my kids haven’t either so surely they are safe.” But how do you know that for sure?

Over the last few decades, we have experienced an explosion in rates of asthma, allergies, autism, ADD, anxiety, depression, autoimmune disorders, childhood cancers, and gastrointestinal issues in the U.S. at the same time the childhood vaccination schedule has expanded significantly. A child born today can expect to receive up to 24 doses of vaccines in the first 12 months of life! We cannot rule out vaccines as potential causes since they have never been tested against neutral placebos.

The U.S. also has one of the worst infant mortality rates coming in at #51 behind countries such as Lithuania, Cuba, Poland, Hungary, Slovakia, and Latvia. Coincidence?

If our medical authoritarians wanted to put an end to the debate over vaccine safety, they could do so easily by publishing the physiological safety studies that prove vaccines don't cause serious adverse events. Yet they refuse to do so.

Instead, they rely on easily manipulated retrospective epidemiological studies, and write off legitimate arguments as anti-vaxxer propaganda while continuing to promote their narrative that vaccines are safe without providing a shred of real evidence backing up their claims. They have no evidence that vaccines are safe because no such physiological studies have ever been performed.

You can’t find what you aren’t looking for

In addition, our pharmacovigilance system called VAERS is widely acknowledged by these same health authoritarians to be unreliable due to its intentional design. VAERS is a passive system and the only people who are required by law to submit reports of adverse events are the drug manufacturers who are notified of an adverse event. Healthcare providers are only required to report certain adverse events yet rarely do because it’s a major pain in the ass and there is no penalty to not file a report.

The rate of adverse events is estimated to be underreported by 10 to 100 times, and the reported rate in VAERS for any particular vaccine is often lower than the rate of adverse events in the clinical trials which should raise flags immediately. The passive nature of the system and underreporting of adverse events make it impossible to determine with any accuracy the safety of a vaccine. It’s a case of not looking for something they don’t want to find.

The CDC had an opportunity to upgrade the system to an active reporting system in 2010, but stopped responding to the group that was designing the software. Apparently, that group discovered an adverse event rate in 1 in 10 vaccinees in a preliminary review of data from Atrius Health in the greater Boston metropolitan area.

Even with the pathetic pharmacovigilance system and insistence that vaccines are safe, there is proof that vaccines do cause injury. According to the most recent report of the National Vaccine Injury Compensation Program (VICP), almost $5 billion has been paid out in vaccine injury claims since 1989, and the burden of proof to win a claim is impossibly high.

Unlike the court of law where one is presumed innocent until proven guilty (theoretically anyway), medical interventions are supposed to be presumed guilty until proven innocent. Unfortunately, that is not really how it works.

What we have here is the illusion of science and evidence-based medicine. The terms “safe” and “effective” are no more than marketing gimmicks like “all-natural” - they mean nothing in this context.

This game is clearly rigged and the referees are complicit as well. The real rules are intentionally not disclosed to the medical community at large nor to the public for reasons which are obvious to me - too much money is at stake to offer an even playing field.

And now, you know the rules to this game.