What the “Casual Cruelty” of Dr. Paul Offit Reveals

Written by Aaron Siri on August 12, 2023. Posted in Current News

Considered by many to be the world’s leading expert on “vaccine safety”

In response to a Twitter exchange I had with Dr. Paul Offit, he penned an article titled The Casual Cruelty of Placebo-Controlled Clinical Trials that makes numerous categorically false claims to argue against proper clinical trials for products injected into babies.

His article is deeply concerning because he is viewed by many as the leading medical authority on vaccine safety who, among other things, sits on the FDA’s vaccine committee that advises on whether to license childhood vaccines.

It is therefore worth reviewing every word of his article. But let’s first review the exchange leading up to it.

On June 25, 2023, in response to Offit’s claim that “all vaccines are tested in placebo-controlled trials before licensure,” I tweeted the following, linking an article with the proof – FDA sources – for my claim:

The next day, Offit responded with this:

I tweeted back later that same day:

By the next day, Offit quietly updated his original claim from “All vaccines…” to “Most vaccines are tested in placebo-controlled trials before licensure.” Offit’s updated claim is still categorically false, but we will return to that below.

Offit also, on July 1, 2023, responded to the above Tweet in a Substack article which, as noted above, is titled The Casual Cruelty of Placebo-Controlled Clinical Trials. His entire article is in bolded text below (you don’t want to miss a word) and, between paragraphs, I provide responses.

Offit’s article opens with this:

Anti-vaccine activists often tell the same story. Only the names of the vaccines, the materials in the vaccines, and the scientists who stand up for vaccines change. But the story remains the same. Government officials, pharmaceutical companies, public health agencies, scientists, and doctors are lying to you about vaccines. They are covering up safety problems. We, on the other hand, by pulling back the curtain on this conspiracy, will tell you the truth. Trust us. Not them.

An incredible opening. In our exchange, I made a statement about vaccines and then provided evidence to support that statement; I cited to FDA documentation for every routine childhood vaccine showing that virtually every single one lacked a placebo control. In response, Offit offers no proof to support his statement to the contrary or to refute my proof.

Instead, in a truly Machiavellian style, his opening paragraph tells you that if you don’t trust him, then you believe in some sort of conspiracy through which everyone else is “lying to you.” The lack of introspection is dumbfounding.

When I and others, like Mr. Kennedy, raise concern about vaccine clinical trials we are not saying “trust us,” we are saying precisely the opposite: we are saying look at the proof yourself, here it is!

Offit, on the other hand, is not only saying “trust me,” while providing no evidence behind the supposed curtain he is pulling back, but he is also saying if you don’t trust him, you are an anti-vaccine conspiracy theorist. Let’s continue.

A recent iteration of this story was told on an episode of Joe Rogan’s podcast. RFK Jr. informed Rogan’s listeners that pharmaceutical companies “never do placebo-controlled trials.” Therefore, because what companies have called “placebos” during pre-licensure trials might have themselves been unsafe, we never really know whether vaccines are safe before licensure. This claim was recently supported by a lawyer [that’s me] working for an anti-vaccine group ICAN, which stands for Informed Consent Action Network. As the word “Informed” implies, only ICAN will really inform you about vaccines.

Offit is apparently not letting the facts get in his way. The claim at issue is about the critical safety testing that is supposed to occur pre-licensure and pre-injection into millions of babies. The reality – the hard, clear reality – is that not a single routine childhood vaccine was licensed based on a long-term placebo-controlled trial.

And I won’t name call you if you don’t agree, nor do I want you or anyone else to take my word for it which is why I cited to the proof for every single vaccine (citations repeated in the chart below). ICAN, an incredible organization that is dedicated to the truth and to “informed consent,” a phrase Offit seems unfamiliar with, does exactly the same by providing support for its assertions. Offit, still no proof. Just a “trust me.”

ICAN’s lawyer wrote, “Robert F. Kennedy, Jr. is on record stating that almost all childhood vaccines were licensed based on clinical trials that did not include a placebo control. [Kennedy] is correct. A placebo is defined by the CDC as a ‘substance or treatment that has no effect on living beings.’ This means a saline injection or water drops in mouth.”

Let’s take a closer look at the ICAN lawyer’s claims. First, the CDC doesn’t regulate vaccines; the FDA does. When researchers at pharmaceutical companies consider human testing, they immediately submit their plans to the FDA, which defines placebo as “inert,” meaning immunologically inactive and harmless. The FDA would not allow any vaccine trials to proceed unless they deemed placebos to be true placebos. (There is one exception, which we’ll get to later.) However, the ICAN lawyer’s claim that vaccine trials didn’t use a placebo control doesn’t mean that vaccines are unsafe or that they don’t work. Indeed, post-licensure studies comparing children who did or didn’t get vaccinated have consistently shown that vaccines are safe and effective.

Still no proof from Offit. More “just trust me.” Offit is now saying, without any proof and with his new definition of placebo, that (trust him) the FDA would never allow clinical trials for childhood vaccines without “true placebos.”

But that is in fact precisely what the FDA has allowed! The proof again is the FDA’s own documentation – which I already cited to him and provide again below.

Amazingly, Offit then says that even if there were no placebo-controlled trials, there is no need to worry because “post-licensure studies comparing children who did or didn’t get vaccinated have consistently shown that vaccines are safe and effective.” But this claim is categorically false!

Putting aside that Offit cites no studies for this claim, there is study after study after study finding that children without vaccines are healthier.

What makes Offit’s casual disregard for placebo-controlled trials so cruel is that, as he is no doubt aware, proving causation between a claimed injury and a vaccine without such a trial is extremely difficult, if not often impossible. (See Section I(iv) of this letter.)

This is why Offit and his kin, in response to a claim of vaccine injury (outside of a few narrow exceptions they trot out to assure you vaccines are otherwise safe), will almost always tell you “it’s just correlation, not causation” or “it’s just anecdotal.” That is precisely why proper clinal trials are so important!

In fact, after licensure, pharma companies selling the vaccine (which cannot be sued for harms anyway) must, under federal law, disclose “only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.”

Pursuant to this requirement, pharma companies have disclosed over 100 serious adverse harms they have a basis to assert are causally related to childhood vaccine products – see Appendix B.

These are often the same harms parents complain of after vaccination! But without a clinical trial to prove causation, these parents (who, let’s remember, vaccinated their child) are called anti-vaxxers and lectured that “correlation does not equal causation” – like a religious mantra.

And everyone should be terribly concerned about this state of affairs because the chronic health of American children has taken a nosedive since the 1980s, which happens to be when manufacturers were given immunity to liability for vaccine injuries and the vaccine schedule grew from 2 routine injected vaccines totaling 7 injections, to 13 routine injected vaccines totaling 54 injections. (See Sections I and VII of this letter).

According to ICAN’s lawyer, the only substances that have “no effect on living beings” are water and salt water. Which is incorrect. Any chemical on this planet (both water and salt are chemicals) if given at a high enough dose, can be harmful. Drink 3-4 liters of water at one time, and you can suffer fatal water intoxication. Eat massive amounts of salt, and you can suffer fatal salt intoxication. In the words of Paracelsus, a 16th century physician, “All things are poisons; for there is nothing without poisonous qualities. It is only the dose which makes a thing poison.”

Hard to believe I need to explain this but when it comes to human beings, a saline injection is considered inert. Human beings are approximately 60 percent water and our blood is 0.9 percent salt by weight.

Hence, saline solution (water with 0.9 percent salt) is used in clinical trials as a substance that has no effect on human beings. It also has a clearly defined safety profile and hence is often used as the control when conducting clinical trials of drugs (but not childhood vaccines).

While I prefer not to jest (given the seriousness of injecting babies with liability-free products), I guess I have to agree with Offit that, if someone tries to inject you with the full content of a syringe that is around three feet tall and half a foot wide (the size needed for 3-4 liters), sure, you should be concerned.

It is telling that Offit needs to venture into the absurd to make his point. This is likely because, no doubt, Offit does not believe a saline injection used as a control would have an adverse effect on living beings.

ICAN’s lawyer argued that the only true placebos were water or saltwater, which isn’t true. Indeed, a wide range of placebos have been used in vaccine trials. These placebos might contain buffers, stabilizing agents, emulsifying agents, or adjuvants, like aluminum salts. They might contain sodium citrate, sodium phosphate, sucrose, or polysorbate-80. At the level contained in vaccines, all these chemicals are safe, including aluminum salts. Therefore, all meet the FDA criteria for a placebo.

First, most clinical trials of childhood vaccines use another vaccine as a control – see chart below – which even Offit must agree cannot be considered a placebo (because Offit’s own definition required that a “placebo,” among other things, be “immunologically inactive”).

Second, when something other than a vaccine is used as a control, it often includes, as Offit points out, numerous ingredients that are entirely unnecessary! This means they are not a placebo! An injection of saline solution is a placebo.

An injection of aluminum salts, which is an adjuvant used for the very purpose of generating a strong immune response, is not a placebo under any definition of the term (again, including Offit’s own definition).

Below we will review the actual control used in the trials for each childhood vaccine – based on the actual evidence from the FDA – and you will see with your own eyes that virtually every single one fails to meet even Offit’s definition.

Not all vaccine trials, however, are placebo controlled. As noted by ICAN’s lawyer: “Prevnar-13 was licensed based on a trial comparing it to Prevnar-7.” Prevnar-7, which was licensed in the United States in 2000, was designed to prevent seven of the most common types of pneumococci that cause pneumonia, meningitis, and bloodstream infections (sepsis), collectively referred to as invasive pneumococcal disease. Prior to the availability of Prevnar-7, pneumococci caused about 17,000 cases of invasive disease, 700 cases of meningitis, and 200 deaths in children less than 5 years of age every year. Prevnar-7 worked, clearly reducing the incidence of invasive disease. To further broaden protection, researchers developed Prevnar-13, which protected against an additional six types. ICAN’s lawyer apparently believes it would have been ethical to study Prevnar-13 pre-licensure with a water or saltwater placebo, knowing that a vaccine already existed that offered considerable protection against a severe and occasionally fatal bacterial infection. I can’t imagine how this kind of trial would have been explained to parents. Not surprisingly, according to a World Health Organization Advisory Panel, the study proposed by ICAN’s lawyer would have been unethical.

Offit does not address what I actually wrote about Prevnar. What I wrote was that “use of vaccines as controls is highly concerning because the control vaccines were virtually never licensed based on a placebo-controlled trial … [and this] is true even for trials of the first vaccine for a target disease. … For example, Prevnar-13 was licensed based on a trial comparing it to Prevnar-7, and Prevnar-7 was licensed based on a trial comparing it to another experimental vaccine.” (emphasis added).

My point, as I clearly wrote, was that because Prevnar-7 was the first licensed vaccine of its kind in the United States, there was absolutely no excuse not to trial it against a placebo. Certainly, there was no excuse to trial it against another experimental vaccine! Offit has no response to that point because there is no excuse for such a morally and ethically bankrupt clinical trial.

Here is where it gets more than casually cruel. All one can say about Prevnar 7 is that it was at best shown to be equally as “safe” as another experimental vaccine. Meaning both could be terribly unsafe.

And to that point, as I pointed out to Offit, when Prevnar 7 was then used as the control in the clinical trial for Prevnar 13, here is what occurred: “Serious adverse events reported following vaccination in infants and toddlers occurred in 8.2 percent among Prevnar 13 recipients and 7.2 percent among Prevnar 7 recipients.”

Meaning, as I wrote in my tweet to him above, “these two vaccines were equally safe by FDA standards – but equally unsafe by any other standard.”

His response to that? None, because this finding is viciously cruel.

This is taken from a long document, reads the rest here substack.com

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