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I don’t have a big presence on Twitter. I don’t find the platform suitable for exploring and critiquing interesting ideas. You can say only so much in 280 characters. It’s great for inciting someone or dropping a witty comeback or link without much context.
At least that’s what I thought. Then I stumbled upon a tweet from Dr. Paul Offit. He’s taught me that you can convey a lot in a few short sentences.
Who is Dr. Paul Offit?
Offit is a big name in vaccines. Beyond what is listed below, he also sat on the Advisory Committee on Immunization Practices for the Centers for Disease Control and Prevention (CDC) and is presently a member of the Vaccines and Related Biological Products Advisory Committee for the U.S. Food and Drug Administration (FDA).
He’s had a say in the approval and/or authorization of many biologics, including the COVID-19 mRNA products.
Briefly, Offit is:
- Director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.
- Maurice R. Hilleman Professor of Vaccinology at the Perelman School of Medicine at the University of Pennsylvania.
- An internationally recognized expert in the fields of virology and immunology.
- A founding advisory board member of the Autism Science Foundation and the Foundation for Vaccine Research.
- A member of the Institute of Medicine and co-editor of the foremost vaccine text, “Vaccines.”
- The author or co-author of more than 150 papers in medical and scientific journals in the areas of rotavirus-specific immune responses and vaccine safety.
- The co-inventor of the rotavirus vaccine, RotaTeq®, recommended for universal use in infants by the CDC.
- A recipient of the Charles Mérieux Award from the National Foundation for Infectious Diseases.
His list of accomplishments goes on.
I don’t pretend to know more about vaccines than he does. I’m just an anesthesiologist and engineer. He must be a very smart person. Which is why this tweet is so baffling:
Why is Offit tweeting about placebos and saltwater right now?
It has to do with a truth bomb Robert F. Kennedy Jr. dropped at a town hall event last week.
According to Kennedy chairman on leave from Children’s Health Defense, he and attorney Aaron Siri sued the U.S. Department of Health and Human Services (HHS) after HHS refused to meet their demand to produce at least one study comparing the safety of a vaccine on the childhood immunization schedule with a true placebo.
In a written response received more than a year later, the HHS did not cite a single such study, instead claiming:
“Inert placebo controls are not required to understand the safety profile of a new vaccine, and are thus not required.”
This stupefying claim made by Melinda Wharton, M.D., MPH, acting director of the National Vaccine Program Office, should be attacked on podcasts and publications everywhere.
How do you know that a new vaccine is safe if it isn’t tested against an inert placebo, Dr. Wharton?
If you are someone who is willing to abandon basic logic and trust every single word spewed by our public health agencies, ask yourself, why then does the FDA demand that medicines be tested against a placebo to ensure safety prior to licensure?
Twitter lit up around this pivotal topic. The tweet from one of the foremost vaccine experts in the world (Offit) was in response to Siri, who, according to Offit, asserted that virtually all vaccines on the childhood vaccination schedule, including RotaTeq (Offit’s brainchild), were not licensed by the FDA based on a placebo-controlled clinical trial.
Let’s break down Offit’s attack on Siri. Offit states: “The purpose of placebos, which are immunologically inert, is to determine the effect of the vaccine.”
Yes, Dr. Offit, one purpose of a placebo is to determine the effect of the vaccine. In order to prove that it works, it must do better than an immunologically inert substance. In other words, it must exceed the so-called placebo effect.
But that’s not the only purpose placebos serve. With regard to safety, a new vaccine has to be compared to something that has the least possible chance of causing deleterious effects.
To be clear, those who eschew a vaccine do not get in line for a shot of an “immunologically inert substance.” They stay away from the vaccine clinic altogether and take their chances.
This is why the placebo must be a true placebo. The best we can possibly do is use saline, a saltwater solution that reasonably matches the sodium concentration in our plasma. It is what is used to dilute medications and replenish blood volume. It’s what you use to store your contact lenses.
Offit then adds this:
“[Aaron Siri] believes that only water or salt water are placebos because they ‘have no effect on living beings.’ That’s absurd. Drink enough water, and you can cause a seizure. Salt can also be toxic.”
Offit is saying that by drinking a large amount of water the plasma sodium concentration in a person can abruptly decrease which, in fact, can lower the seizure threshold. He’s not wrong, it does happen in pathological conditions, especially in the critically ill.
Can salt be toxic? Yes. Ingestion of a large amount of salt will stimulate properly functioning kidneys to increase the absorption of free water, thus mitigating the effect of the salt load. This can cause volume overload and put a person at risk for heart failure and pulmonary edema.
So what — if not 0.2 ml of saline — should we use for a placebo, Dr. Offit? A tiny aliquot of adjuvants (that can include elements like aluminum)? Pro-inflammatory lipid nanoparticles? Viral or toxin deactivators like formaldehyde? Preservatives like thimerosal that contain mercury, one of the most potent neurotoxins known (yes, mercury in this form is still in some flu vaccines according to the CDC)?
All of these substances are “immunologically inert.”
But why would you consider using them as a placebo control if not to mask the potential harm of the vaccine in question?
Is that how inventors of vaccines for our children view placebos? Is that how advisory committee members on the FDA view them? What about the other advisory board members of the Autism Science Foundation? Why would anyone trust any vaccine on the childhood immunization schedule after such comments?
You don’t have to be Maurice R. Hilleman Chair of Vaccinology at the Perelman School of Medicine to see that your comments here are misleading, disingenuous and purposefully inciting.
Moreover, they don’t make any sense.
What would other recipients of your long list of awards have to say about your comments on placebos? I don’t think they would approve, sir.
Your public statements also sully the excellent reputation of the Children’s Hospital of Philadelphia and those who were lucky to train there, like me.