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Robert F. Kennedy Jr claims in his book The Real Anthony Fauci on pages 594-595:

Most medicinal products cannot get licensed without first undergoing randomized placebo-controlled trials that compare health outcomes — including all-cause mortalities — in medicated versus unmedicated cohorts. Tellingly, in March 2017, I met with Dr. Fauci, Francis Collins, and a White House referee (and separately with Peter Marks from CBER at FDA) to complain that HHS was, by then, mandating 69 doses of sixteen vaccines for America’s children, none of which had ever been tested for safety against placebos prior to licensing.

Dr. Fauci and Dr. Collins denied that this was true and insisted that those vaccines were safety tested. They were unable, however, after several weeks, to provide us a citation for a single clinical trial using an inert placebo against a vaccine. In October 2017, Del Bigtree and Aaron Siri — who both attended these meetings — joined me in suing HHS under the Freedom of Information Act to produce the long promised safety studies. Ten months after the meeting with Fauci and Collins, on the courthouse steps, HHS admitted that we were, in fact, correct: none of the mandated childhood vaccines had been tested for safety in pre-licensing inert placebo tests.

Is the claim that none of the mandated childhood vaccines went through placebo-controlled trials that looked at whether or not the vaccine has an impact on mortality true and HHS admitted to that, true?

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    You might want to the the FDA document giving guidance on control groups in clinical trials. Using a placebo is one of six options, e.g., it is not required under FDA regulations.
    – doneal24
    Commented Jun 19, 2023 at 18:42
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    @Giacomo1968, I think your edit mangled the quotation (I don't have enough reputation here to roll your edit back ...)
    – Ben Bolker
    Commented Jan 4 at 14:38

1 Answer 1

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Placebos are control groups in studies which are designed to account for two things:

  • Other aspects of a treatment or therapy than the "active" component which have a positive or negative effect.
  • The "placebo effect", where a patient believes that they are receiving a beneficial treatment and respond accordingly.

This control is distinct from randomization or blinding, which address different confounders, and randomized, double-blinded, placebo-controlled studies are, when properly designed and executed, excellent evidence for treatment safety and efficacy. Placebo treatment arms are not a requirement for a study to be able to evaluate treatment safety, although they can be useful.

To the claim in question, that vaccines are not adequately trialed for safety because they are not tested against placebos:

All vaccines are tested by clinical trial. These trial phases (three of which are prior to approval and one of which is post-approval) ensure that the vaccine is safe and effective. Vaccines against things for which we have not had a vaccine before are trialed against placebos. For example, the Pfizer COVID trial protocol:

A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN AND YOUNG ADULTS

  • Experimental: Mid-Dose, ≥6 Months to <2 Years Mid-Dose, (20mcg), 2 doses 21 days apart
  • Placebo Comparator: Placebo, ≥6 Months to <2 Years

As another example, the Salk Vaccine Trial for the Polio vaccine in 1954:

Across the United States, 623 972 schoolchildren were injected with vaccine or placebo, and more than a million others participated as “observed” controls.

This is not the case for new vaccines for diseases that we already vaccinate against. Those are tested against standard of care (the old vaccine). Doing otherwise would be unethical.

The lawsuit in the claim was filed in 2017 by Aaron Siri of the Informed Action Consent Network, an antivaccine group.

Moreover, these trials either had no control group or a control group which received other vaccines as a “placebo.” This means each new vaccine need only be roughly as safe as one (or in some cases numerous) previously licensed vaccines. Such flawed and unscientific study designs cannot establish the actual safety profile of any vaccine. The real adverse event rate for a vaccine can only be determined by comparing subjects receiving the vaccine with those receiving an inert placebo. Yet, this basic study design, required for every drug, is not required before or after licensing a vaccine.

It is not ethical to withhold medical care from people in order to create a control group. Any clinical trial that withheld standard of care to create a comparison group would not be approved by an Institutional Review Board. Examples of that type of unethical behavior are not to be repeated.

It is not necessary or desirable to test against a placebo when a safe, effective treatment already exists. The things that a placebo control group accounts for (indirect treatment effects and the placebo effect) are also controlled for by using a different therapy. Using a placebo in place of a treatment in the control arm is both unethical and unnecessary.

As for this part of the claim:

HHS admitted that we were, in fact, correct: none of the mandated childhood vaccines had been tested for safety in pre-licensing inert placebo tests

This is an example of ICAN using a legal tool to create a narrative. This is a long and interesting article detailing how lawsuits and dishonesty are combined to make narratives, but I will excerpt the relevant example:

  1. The group files a suit and asks for an extremely specific document under the Freedom of Information Act

    One of ICAN’s first forays into using FOIA to create talking points occurred in 2017,with a request based on the National Childhood Vaccine Injury Compensation Act. On August 25, 2017, ICAN submitted a FOIA request to HHS seeking “any and all reportstransmitted to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate by the Secretary of HHS pursuant to 42 U.S.C. §300aa-27(c).”

  2. The document request is so specific that it asks for something that does not exist

    HHS replied to the request stating, “the [Department]’s searches for records did not locate any records responsive to” ICAN’s request despite conducting a “thorough search of its document tracking systems and a comprehensive review of all relevant records.”

  3. The group states that the absence of a specific document means something incredibly broad - in this case, that all vaccines are unsafe

    ICAN stated on its website that the stipulation order confirmed non-compliance and that “HHS has not acted in its duties regarding vaccine safety, forcing 78 million American children into a vaccine program with no safety provisions.”

This is a classic motte and bailey fallacy example - "vaccine programs have no safety provisions" is the bailey, and "HHS may not have fulfilled one congressional notification provision of 42 U.S.C. §300aa-27(c)" is the motte.

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    @Christian - in the strictest possible terms, perhaps, but what the answer is saying is that better than placebo tests were conducted. RFK's "these were not placebo tested" is either a gotcha under the strict definition or working from the preassumption that all vaccines are bad and a placebo would be better.
    – jdunlop
    Commented Jun 19, 2023 at 20:08
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    @Christian - that's fatuous. If the original vaccine in a chain was tested against a placebo, and each subsequent vaccine is tested for greater efficacy and safety against its predecessor, then a) by the transitive property, the new vaccine is safer than a placebo, and b) you're not committing a breach of medical ethics by not providing a treatment when one exists.
    – jdunlop
    Commented Jun 19, 2023 at 21:08
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    The placebo group is unaware of the nature of their dose - think about testing bullet-resistant vests by giving out real and fake vests to LEOs and then count the wounded in each group after a year. Pretty unethical to my mind.
    – bukwyrm
    Commented Jun 20, 2023 at 12:58
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    @Christian This answer explains with good sources that a) for medical treatments the gold-standard is a placebo-controlled trial as you say yourself and b) for vaccines the widely accepted gold-standard is comparison with previously approved vaccines if available and uses placebos only in cases where no other vaccines are available. It also explains why the widely accepted consensus is the most ethical thing to do.
    – quarague
    Commented Jun 21, 2023 at 6:32
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    ... and, in fact, why testing against placebo in this case would not only be not the gold standard, but actively unethical and illegal. Commented Jun 21, 2023 at 10:43

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