RFK Jr doesn’t understand placebos, biomedical research, or ethics.
FDA-approved vaccines undergo placebo-controlled trials. RFK Jr is pushing unethical, illegal, & dangerous policies.
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A personal note: for those who follow me on Instagram or Facebook, you’ll know that I have been caring for my stepfather Bill for the past several years. In November, I finally moved him to PA into an independent living facility so I could better oversee his health and well-being. Unfortunately, he had a stroke and thalamic brain bleed last Monday and, with no surgical options and no path to recovery with any quality of life, I made the difficult decision to transition him from the ICU to palliative care. He died on Wednesday, April 30, 2025.
I am his sole ‘family,’ POA, and executor of his will, so I am sorting through a lot of emotions, logistics, and legal matters. It has been a very long couple of weeks following a very long 6 months, so I appreciate your patience and understanding as I likely will not be writing as much or as frequently as I often do. That being said, Bill would smack me if I didn’t continue to do the things I care about. That includes my actual job in biotech (my boss has been incredibly supportive and I am grateful to her), my science communication here, and my hobbies like running.
So in honoring that — and his detestation of the Trump administration and the harms they are unleashing, let’s get into it.
RFK Jr. is yet again, lying about vaccine research and clinical trial processes.
Last week, RFK Jr. once again, revived his long-held lie about the process of vaccine clinical trials — that they do not undergo placebo-controlled clinical trials. This is not a new lie from him. He’s said repeatedly over the last 20 years, including in July 2023 on “Fox and Friends” that “vaccines are the only medical product that is not safety-tested prior to licensure.”
He has said that “vaccines are exempt from pre-licensing placebo-controlled trials.”
Let’s me be perfectly clear: these claims are objectively false.
Last week though, he took it a step further. Now, in his role as HHS Secretary, he has indicated that he is going to require all to-be-released vaccines to undergo placebo-controlled trials before approval.
This does not just apply to vaccines for diseases that currently have no vaccine options, but also all updated vaccine formulations for existing vaccines.
RFK Jr’s proposed policy not only violates existing FDA laws and regulations, but is also highly unethical. And if this is allowed to be implemented, will cause extensive harm, suffering, and damage to public health.
Every FDA-approved vaccine has been tested in randomized, placebo-controlled clinical trials.
Polio? Yes. Over 600,000 children were enrolled.
Measles, mumps, rubella? Yep. Measles vaccine trials started in the 1960s.
Hib (Haemophilus influenzae type b)? Yes.
Diphtheria, tetanus, pertussis (DTP)? Yep.
Meningococcal (ACWY)? Yes.
Varicella (chickenpox)? Yes.
Pneumococcal? Yes.
Rotavirus? Yes.
RSV? Yes.
Hepatitis A? Yes.
Hepatitis B? Yes.
Influenza? Yes.
HPV? Yes.
Shingles (Zoster)? Yes, even a phase IV trial.
This isn’t a matter of opinion. This is verifiable, objective reality. It’s how science and regulatory oversight work. But since RFK Jr. know nothing about science, regulations, and clinical research, he just keeps lying — and the repercussions will be catastrophic.
Placebo-based clinical trials are the cornerstone of biomedical research.
The double-blinded, randomized, placebo-controlled clinical trial is one of the gold standards for modern biomedical therapeutic development. These clinical trials, where participants are provided either the therapeutic intervention or an inert version allow us to determine if a drug, vaccine, or biologic is safe and effective before it reaches the general public.
This is not just true for vaccines. This is true for nearly all FDA-approved and regulated medicines that we have, including:
Chemotherapy drugs
Antibiotics
Diuretics
Pain relievers and anti-inflammatory medicines
Immunomodulators
Biologics
Blood pressure medicines
Anesthetics
Respiratory and allergy medicines
Psychiatric and neurological medicines
Cardiovascular and metabolic drugs
Gastrointestinal therapeutics
Reproductive and hormonal medications
and many others….
You know what this doesn’t apply to? The entire unregulated dietary supplement and wellness industry, in which RFK Jr’s supplement of the day, non-medical grade methylene blue, falls into. Yep, supplements were removed from FDA oversight because of political and financial interests.
But I digress.
When a medicine is evaluated for human use for the first time, it undergoes rigorous, clinical trials following preclinical in vitro and animal testing. These trials must be representative of the demographics that might receive that medicine to enable us to generalize the data to the public.
Only AFTER those trials are completed can it be submitted to a regulatory agency for review and possible approval. The FDA in the US requires a BLA submission, other global regulatory agencies like European Medicines Authority (EMA) or Health Canada have similar approaches.
Clinical trials require comparison to placebo or the current standard of care for any medical intervention.
Vaccines are no exception. Vaccines face some of the most rigorous scrutiny, in large part because of the decades-long disinformation campaign RFK Jr. has waged.
What is a placebo, though?
A common refrain from anti-vaccine activists is that a vaccine needs to be tested against “saline” in order for them to feel it’s an appropriate “placebo” trial.
A placebo is not saline solution.
A placebo is any control designed to be inert — something with no therapeutic effect. An appropriate placebo is critical to experimental design, especially in clinical trials. If the wrong placebo or controls are used, it can throw all of the data you collect out the window, unusable.
An appropriate placebo allows scientists to be able to clearly analyze whether the test intervention (a vaccine, oral medicine, IV therapy, etc.) actually works and whether it causes any unintended effects.
Think back to science class on independent and dependent variables. The independent variable is the one you deliberately change (e.g., giving a vaccine), and the dependent variable is the one you measure (e.g., whether people develop immunity or experience side effects).
For the data to be meaningful, everything else must stay the same. If you change multiple variables at once, you can't tell which one caused the outcome. That’s called introducing confounding variables—and it wrecks the validity of your experiment.
Let’s say you’re doing a classic kid science project: growing mold on bread.
Your hypotheses are moisture or darkness promote mold growth. So you set out two slices of bread:
One is left dry on the counter (your control).
The other you moisten and stick in a dark drawer (your test sample).
After a week, the counter slice has a little mold. The moist, dark slice is covered in it. You exclaim: “This proves mold grows more in the dark and moist!”
But your conclusion doesn’t hold up because you changed two variables at once. You have no idea whether it was the moisture, the darkness, or the combination that promoted more mold growth on that slice of bread. Your experimental design invalidated your ability to draw an accurate conclusion.
The correct approach? You need to test each variable independently:
One slice stays dry on the counter (baseline control).
One is dry but in the dark.
One is moist but on the counter.
One is moist and in the dark (your multiple variable test).
Only then can you compare outcomes and see which factor (or combination) actually contributes to mold growth.
This approach applies to clinical trials—except the stakes are much higher.
Vaccine trial placebos are identical to the vaccine candidate EXCEPT for the active ingredient.
RFK Jr. and other anti-vaccine activists claim that vaccine trials aren’t actually testing against placebo because they’re not using saline (salt solution). But this is not only wrong, it ignores fundamental tenets of scientific research — plus regulatory science and ethics laws.
The purpose of a placebo isn’t to be just salt water, it’s to match everything about the medication administration and the formulation except for the active ingredient (in vaccines, those are the antigens, the parts that activate the immune response). That includes additional ingredients, volume, and how it is administered.
Saline is the wrong placebo for vaccine trials because vaccines contain more ingredients than just an antigen.
Vaccines are complex medicines designed to train your immune system to develop memory immunity against a disease-causing microorganism.
Vaccines contain more ingredients than just the antigens (isolated proteins of a pathogen, mRNA sequences that encode an protein of a pathogen, an entire pathogen that’s been inactivated, an inactivated toxin…)
Vaccines also include:
Stabilizers and emulsifiers to keep the solution in suspension and ensure shelf-life
Preservatives in multi-dose vaccines so they do not become contaminated
Adjuvants like certain salts that can augment the immune response
Trace impurities from manufacturing processes
For details on why vaccines have various ingredients, read this article I wrote:
We know EXACTLY what’s in vaccines – because we put it there
Every ingredient in a vaccine serves a purpose, is rigorously tested, and is there for a reason. Regulation of vaccines extends to more than just the final medicine—the entire process of making a vaccine is regulated.
Using only saline as a control for a vaccine clinical trial ignores these other components.
If you want to assess whether the active ingredient is causing an effect, whether it be reactogenicity like fever, soreness, etc., or the immune response you are trying to elicit, you have to control everything else in the formulation. Otherwise, you can’t say if the other ingredients are contributing to it. (and yes, excipient ingredients are tested separately for safety prior to vaccine formulations).
Most often, placebo is not saline: it is everything else in the vaccine except the antigens. This is called a carrier control or formulation control, and it’s the scientifically valid way to conduct these studies.
This is true for non-vaccine medicines too.
Inhaled asthma medications are often tested against placebo that includes the same propellants, excipients, and delivered through an inhaler, but no active bronchodilators.
Ophthalmic medicine placebos will include the same emulsifiers, oils, but will lack the active ingredient like cyclosporine.
Chemotherapeutic placebos, especially intravenous medicines, also have placebos that are altered for physical appearance and viscosity, so that when a patient is receiving their IV bag, they cannot visually tell the difference.
A placebo is not automatically “saline” or some arbitrarily selected “natural” substance: it is designed to mimic everything else in a medicine with the exception of the active compound being evaluated.
Vaccines are tested using placebo-controlled trials before they are approved for the first time. The fact that RFK Jr claims otherwise is an outright lie designed to undermine one of the most studied and regulated groups of medicines.
Existing approved medicines are updated through bridging and comparability studies, not placebo trials.
This is the part of RFK Jr’s new “policy” that gets especially dangerous. He is either deliberately lying, showing his complete ignorance of science and regulatory processes, or both.
When a medicine has already been subjected to rigorous, double-blinded, placebo-controlled clinical trials, has been submitted via Biologics License Application (BLA) to the FDA, is reviewed and approved, that medicine (vaccine or otherwise) is now available for the intended population.
The Food, Drug, and Cosmetic Act that laid the groundwork for this process was enacted in 1938, so you can imagine that science, our technologies, and our knowledge have evolved quite a bit in the past 87 years.
That means some older medicines may require updating. These updates can include changes to formulation itself, changes to manufacturing processes, or changes to how the medicine is delivered. Can you imagine if penicillin was formulated and manufactured exactly as it was in 1943?
Once a medicine has been proven effective via placebo-controlled trials and is approved, updates to the medicine don’t require a placebo-controlled trial.
These updates might include:
Switching the manufacturing facility
Adjusting a stabilizer
Creating a generic version after patent expiration
Adding an enteric coating to prevent stomach upset
Tweaking a vaccine strain to match circulating viruses (e.g., annual flu shots, updated COVID-19 boosters)
In these cases, we conduct bridge studies. These are comparative trials to evaluate whether the new version performs as well as the original, proven, and approved version. The bar is high—new formulations must be equivalent or better in safety, efficacy, and quality.
In vaccine bridge studies, safety and immunogenicity are key assessments. If there is a change in the vaccine formulation, whether it is a different emulsifier, stabilizer, or alteration in the antigen structure, we want to see whether the change in the formulation impact the safety profile and the immune response that is elicited by the vaccine (that is the therapeutic goal of a vaccine).
When the DTP vaccine (diphtheria, tetanus, pertussis) was replaced with the DTaP (diptheria, tetanus, acellular pertussis) vaccine in the 1990s, several DTaP vaccine formulations were tested against the existing DTP vaccine. Because placebo-controlled trials were conducted decades prior with the DTP vaccine, the goal was to see whether the acellular pertussis component was safer yet elicited similar immune memory. Deliberately withholding an existing life-saving vaccine would endanger children exposed to these diseases when there was a vaccine already.
The same is true for annual flu vaccine formulations, when Gardasil (HPV vaccine) was updated from Gardasil 4 to 9, and so on. These updated clinical trials used the previous vaccine as the control, because we have the placebo data already and it is unethical to withhold an already approved version of the vaccine.
Repeating placebo trials when a standard of care for the medical condition in question exists is unethical & illegal.
Yep. You can’t knowingly deny someone an effective treatment just for the sake of repeating a trial. That’s why there are laws and regulations governing this, including:
The Declaration of Helsinki is a set of ethical principles for medical research established by the World Medical Association.
FDA Code of Federal Regulations (21 CFR Parts 50 and 56) which define the ethical and regulatory requirements for protecting human subjects in research, especially research that may involve the FDA (such as regulated medicines or medical devices).
International Council on Harmonization (ICH) E10 Guidelines which provides a framework for the selection of scientifically and ethically appropriate control groups in clinical research.
WHO Guidance for Good Clinical Practice provides a global framework for standards in conducting biomedical research with human subjects — especially important in underserved countries that lack regulatory bodies to create these for them.
These establish ethical principles that prohibit withholding effective care during research. If RFK Jr got his way and enforces his “policy” of requiring placebo-controlled trials for any new vaccine, including updated formulations for seasonal flu and otherwise, these trials would be in direct violation of all institutional review boards (IRB) and regulatory agencies that have defined these guidelines.
If RFK Jr takes it a step further and thinks ALL new medicines need placebo-controlled trials, then we would have:
No generics—generics are tested against name brand medicine once the patent expires.
No annual flu vaccine—seasonal flu vaccine formulations are tested against previous flu vaccine formulation (the first inactivated flu vaccine WAS placebo-controlled in the 1940s, btw).
No improved drug formulations—whether that means changing a pill to liquid, oral to IV, or improving stabilizers or preservatives to improve shelf-life and reduce contamination.
No expansion of manufacturing capacity—so as population grows, we wouldn’t be able to scale manufacturing to continue to deliver medicines at the same pace.
No tweaks for supply chain optimization—if shortages of supplies demanded new sources, not even this could be adjusted.
This would freeze scientific progress. And it would cause a lot of preventable illness and death in the process.
We don’t use placebo when testing new medicines for a health condition that has a standard of care, either.
It is unethical to withhold existing treatments for someone participating in scientific research. For new cancer therapeutics or combination treatments, clinical trials use standard of care as the control, which is compared to the potential new intervention.
The Checkmate 067 trial for unresectable melanoma compared standard of care, ipilimumab, to nivolumab and a combination of ipilimumab and nivolumab.
Ipilimumab is a monoclonal antibody that blocks a protein called CTLA-4, which allows the immune system to better recognize and kill cancer cells and is the standard of care for metastatic melanoma since 2011. Nivolumab is another monoclonal antibody that blocks a different protein, PD-1, which also allows T cells to become activated more readily to recognize and kill cancer cells.
This trial determined that median survival for standard of care (ipilimumab) was 19.9 months (1.5 years), whereas nivolumab treatment increased survival to 36.9 months 3 years), and combination treatment increased survival to 71.9 months (nearly 6 years).
You can see why using a placebo here is unethical, right?
When there is no effective standard treatment for a given medical condition, placebo controls are ethical and scientifically appropriate. For most cancer trials and other trials with existing medicines, we use an active comparator—the standard treatment for that condition—to assess whether the new medicine is equivalent or better (sometimes called superiority or non-inferiority).
RFK Jr. doesn’t understand ethics, science, or public health. And he doesn’t care about it, either.
RFK Jr. and his anti-regulatory wellness allies scream about the lack of placebo trials—not because they care about safety or ethics, but because they don’t understand anything about science. They pretend that updated vaccines or medicines are "untested" if they don’t go back to square one with an inert placebo trial. That’s illogical and unscientific. It's like saying a new iPhone must be tested against a telegraph before it can be sold.
The hypocrisy? Not once have RFK Jr. or his allies demanded placebo-controlled trials for:
The unproven supplements they sell and advocate for
The dangerous detox and chelation ‘therapies’ they promote, including by his “autism/vaccine investigator” David Geier
The inaccurate and unregulated “health tests” he and his buddies like Mark Hyman sell to convince people they have health problems they don’t have
The overpriced “immune boosters” they peddle
Dietary supplements and unregulated wellness products don’t have any clinical trials.
They have no IRB approval, no good manufacturing process certification, no regulatory review or oversight whatsoever.
Their outrage is performative.
RFK Jr and his MAHA allies don’t care about safety—they care about profiting off fear and pseudoscience.
RFK Jr is a clear and present danger to humanity.
RFK Jr’s claims aren’t just wrong—they’re dangerous. He is using his role at HHS to lie to the public, erode trust in science, destroy our public health infrastructure, gut medical research, and implement harmful policies that WILL prevent people from accessing life-saving medicines.
Science saves lives. Lies, ignorance, & disinformation do not.
Now, more than ever, we all must join in the fight for science.
Thank you for supporting evidence-based science communication. With outbreaks of preventable diseases, refusal of evidence-based medical interventions, propagation of pseudoscience by prominent public “personalities”, it’s needed now more than ever.
More science education, less disinformation.
- Andrea
ImmunoLogic is written by Dr. Andrea Love, PhD - immunologist and microbiologist. She works full-time in life sciences biotech and has had a lifelong passion for closing the science literacy gap and combating pseudoscience and health misinformation as far back as her childhood. This newsletter and her science communication on her social media pages are born from that passion. Follow on Instagram, Threads, Twitter, and Facebook, or support the newsletter by subscribing below:
I’m so sorry for your loss. Your strength and clarity in the face of such a personal tragedy is deeply moving. You continue to speak with extraordinary scientific rigor and moral clarity and it’s a service to all of us, especially now when disinformation is not just tolerated but elevated.
Your work stands in stark contrast to figures like Casey Means, whose promotion to Surgeon General would be a triumph of branding over science. While you provide facts, context, and ethical nuance, she packages wellness marketing as medicine. We need more voices like yours in public discourse, not more pseudoscientific influencers elevated to positions of authority.
Thank you for all that you do, especially in the hardest moments.
Very sorry for your loss 🙏