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What is the Placebo Pyramid Scheme?

By / / Aaron Siri, aluminum, control vaccine, hpv myths, meningitis vaccines, placebo effect, pre-vaccine era, RFK Jr, saline placebo, vaccinated vs unvaccinated, vaccine safety studies

Have you heard of the placebo pyramid scheme?

Anti-vaccine influencers have been pushing the Placebo Pyramid Scheme - the idea that vaccines are not safe because they have not been tested with saline placebos.
Why does Aaron Siri state that the source is the FDA when you will find neither his placebo pyramid scheme nor anything stating that the licensure was not based on any placebo controlled trial on the fda.gov site?

It is a great example of how anti-vaccine influencers can move the goalposts and trick you into thinking that vaccines are not safe.

What is the Placebo Pyramid Scheme?

Remember when anti-vaccine influencers used to claim that there were no double-blind, placebo controlled randomized clinical trials for vaccines?

Anti-vaccine influencers have been pushing the Placebo Pyramid Scheme - the idea that vaccines are not safe because they have not been tested with saline placebos.
All vaccines are well tested to make sure they are safe and we know they work well, as they have saved millions of lives since the pre-vaccine era.

And when we listed the double-blind, placebo controlled randomized clinical trials for vaccines, what was their response?

Anti-vaccine influencers have been pushing the Placebo Pyramid Scheme - the idea that vaccine safety studies are invalid because they don't always use saline placebos.
If the placebo pyramid scheme were remotely true, every vaccine and combination of placebos and vaccines, some of which were tested against saline placebos, would have to cause the exact same type of side effects, otherwise the differences would still be detected.

They say ok, but where are the double-blind, placebo controlled randomized clinical trials using a saline placebo?

“Most people who received a placebo in the Gardasil trials got aluminium adjuvant. However there was one protocol (Protocol 18) conducted in 9-15 year old girls and boys where the placebo used was a saline solution. In this study 1184 were randomised to receive the vaccine and 596 randomised to receive the saline solution placebo. The proportion of participants completing the study was similar in each group. The proportion of systemic events was comparable in each group.”

Was the Gardasil vaccine ever compared with a placebo?

And we showed them, because lot of vaccines, from polio and measles to HPV and COVID-19, have been tested using a saline placebo!

Not that placebos have to be saline…

“Randomisation and the use of placebo interventions are designed to control for confounding effects, such that significant differences in disease incidence or adverse effects between the vaccine and control groups can likely be attributed to the vaccine. However, randomised, placebo-controlled trial designs often raise ethical concerns when participants in the control arm are deprived of an existing vaccine. Furthermore, testing a new vaccine against placebo is scientifically and ethically fraught when the hypothesis being tested is whether an experimental vaccine is more efficacious than one already in use in the same or in other settings.”

Placebo use in vaccine trials: Recommendations of a WHO expert panel

In fact, ethically, they typically shouldn’t be saline!

But of course, that doesn’t mean that these vaccines aren’t safe.

The Initial Prevnar Vaccine Safety Studies

Consider the initial Prevnar or PCV-7 vaccine.

“In the United States, 1 year after the introduction of PCV- 7 into the national immunization programme, the incidence of invasive pneumococcal disease caused by serotypes of pneumococci used in the vaccine was reduced by 100% (95% CI, 87.3–100%) among vaccinated children aged <1 year. All invasive pneumococcal disease was reduced 3 years after introduction by 84.1% in children aged <1 year, by 52% in adults aged 20–39 years and by 27% in individuals aged >60 years. Subsequent surveillance results 2 years after introduction have shown a 75% decrease in invasive pneumococcal disease among children aged <5 years. The decline in incidence among people aged >5 years who did not receive the vaccine is probably the result of decreased transmission from younger, vaccinated children – a phenomenon known as “indirect immunity” or “herd immunity”. In the United States, an estimated 68% of all prevented cases of invasive pneumococcal disease were attributed to this indirect effect.”

Pneumococcal conjugate vaccine for childhood immunization – WHO position paper 2007

A vaccine that is known to be safe, effective, and necessary.

A vaccine that you have been able to benefit from even if you have skipped or delayed getting vaccinated!

“PCV-7 has been tested in trials in different parts of the
world and has been proven to be safe and well tolerated
even among children infected with HIV. No significant
adverse events have been identified in post-marketing
surveillance in the United States where >20 million children have received the vaccine.”

Pneumococcal conjugate vaccine for childhood immunization – WHO position paper 2007

A vaccine that is known to be safe, effective, and necessary, even though it wasn’t studied with a saline placebo in its initial clinical trials.

Instead, children received a meningococcal control vaccine.

But how do you know the vaccine is safe if there was no saline control?

“Historical comparisons prior to the administration of the vaccine revealed nothing of significance related to either the pneumococcal or the meningococcal vaccine.”

The safety of 7-valent pneumococcal conjugate vaccine

In addition to the fact that the children in the randomized, double blind study had surveillance for up to 42 months, many post-licensure studies have found no safety issues.

Oh, and then there is the simple point that the Prevnar vaccine has been studied with a saline placebo!

“The placebo administered at the initial visit was 0.9% saline and was visually indistinguishable from the vaccines.”

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Prime-Boost Strategy for Pneumococcal Vaccination in Adult Liver Transplant Recipients

The study was in adults, but still, it used a saline placebo and found no safety issues with the Prevnar vaccine.

And then there is the fact that in another study, children only received the Prevnar vaccine!

A vaccinated vs unvaccinated study!

“Forty-six were vaccinated with PCV7 and 50 were not.”

Pneumococcal vaccination in children at risk of developing recurrent acute otitis media – a randomized study

What did they find in this study?

Not surprisingly, they found that the vaccinated children had fewer ear infections, fewer trips to the ER, and were less likely to need ear tubes than unvaccinated children!

“No adverse events were reported with the vaccine.”

Pneumococcal vaccination in children at risk of developing recurrent acute otitis media – a randomized study

And they did not find any safety issues.

Why Saline Placebos Are Not Often Used

While anti-vaccine influencers constantly call for the use of saline placebos for the control group, there are important reasons why they aren’t often used today.

Remember, in addition to using a placebo in a clinical trial, you want the trial to be double blinded and randomized.

With a saline placebo, it becomes harder to keep the folks getting vaccinated from knowing if they got the real vaccine or the placebo.

Why is that important?

The placebo effect!

If they think they got the placebo, they might not report side effects.

You want to avoid this kind of bias and you do that by making the placebo mimic the vaccine as much as possible. And that’s why the control group’s placebo might be saline mixed with aluminum salts or more likely, why folks might get another vaccine instead – a control vaccine.

Why another vaccine?

Ethically, instead of a saline placebo, if another vaccine is available that protects against the same or similar disease, all participants in the trial should benefit from that protection. For example, if you are studying a meningitis vaccine, you can’t leave half of the people in the trial at risk to get meningitis! You give them a different meningitis vaccine instead.

Consider what happened in the clinical trial of a 14-valent pneumococcal polysaccharide vaccine that used a saline placebo. Nearly twice as many people in the placebo group died with pneumonia!

What happens when vaccine safety studies use saline as a placebo? Folks in the placebo group get sick and die!
What happens when you use saline as a placebo? Folks in the placebo group can get sick and die from the disease you are trying to prevent!

At the time, in 1977, there wasn’t another pneumonia vaccine to use as a control vaccine, but ethically, you couldn’t do this trial now with a saline placebo and just let those folks die.

That’s why they were able to use saline placebos in the initial COVID-19 vaccine trials. There was no equivalent vaccine to give the control group.

What’s next for COVID-19 vaccine trials though? Updated or second generation COVID vaccines likely shouldn’t continue to use saline placebos, should they, when safe and effective COVID vaccines are already available?

The Anti-Vaccine Propaganda Scheme Over Placebos

While anti-vaccine influencers try to scare you away from getting vaccinated with talk about saline placebos, remember how many lives have been saved by the vaccines in their so called placebo pyramid scheme.

Think about how many lives will be put at risk if more people listen to their propaganda and skip or delay getting vaccinated and protected.

And know that these vaccines have been well tested and are safe, with few risks, and that they are very necessary.

More on Vaccine Safety Studies

Last Updated on August 11, 2024