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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?

Oddthinking
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Christian
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    You might want to the the [FDA document](https://www.fda.gov/media/71349/download) 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 Jun 19 '23 at 18:42

1 Answers1

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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).”

  1. 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.”

  1. 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.

CJR
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    The answer seems to be that some vaccines like the Pfizer COVID vaccine get placebo tested and others don't. This leaves open whether the claim that all the sixteen vaccines that were on the schedule in 2017 had no placebo testing done on them or whether some of those had placebo testing done. – Christian Jun 19 '23 at 19:43
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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 Jun 19 '23 at 20:08
  • @jdunlop : Placebo-control tests are generally considered the gold standard in medicine. Testing against previously licensed vaccines for the same illness can tell you something about whether this particular vaccine is better than the previously approved one but it doesn't tell you whether the vaccine is safer than not taking any vaccine at all. – Christian Jun 19 '23 at 21:01
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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 Jun 19 '23 at 21:08
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    I guess the point is that for a drug that *treats* a specific disease, you can test it for *efficacy* in sick patients against the current drug of choice (since you have to give them some kind of treatment), and you can test it for *safety* in healthy patients against a placebo (since they don't otherwise need any treatment). But in the case of a vaccine, *everybody* needs the treatment, and so there isn't any group to whom you can ethically give the placebo. – Nate Eldredge Jun 19 '23 at 21:20
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    @jdunlop: So the question becomes, *was* the "original vaccine in the chain", which could have been a long time ago, tested against a placebo in a way that modern standards would consider sufficient? – Nate Eldredge Jun 19 '23 at 21:21
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    @NateEldredge : Vaccines aren't treatments. They are preventative. Many times vaccines are given with the hope of creating herd immunity and to create heart immunity you don't have to give them to everyone. You can have an ethical discussion about the tradeoff between having more knowledge about safety and treating more people but you have that tradeoff a lot of times when it comes to drug approval and if we make the tradeoff being open about making the tradeoff is the honest thing to do. – Christian Jun 19 '23 at 23:30
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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 Jun 20 '23 at 12:58
  • @Christian I have edited the answer to be more clear about what a placebo control does and why it's not used here. I'm not going to enumerate all the vaccines and their trial designs for the same reason that I wouldn't list the state of asbestos test results for breakfast cereals in a question about the risks of mesothelioma from asbestos in cheerios. – CJR Jun 20 '23 at 14:43
  • @CJR : Currently, you voice your opinion on when placebo-controlled trials are desirable. If there's a general consensus that placebo-controlled trials are not the gold standard for medicine (e.g. not always desirable), you could cite a source for that. In this particular debate, the way RJK jr makes the case, negative side effects with the DPT vaccine could have revealed earlier if someone would have run the trial. If what RFK claims is true, the 2017 trial was after Fauci made the false claim that vaccines are placebo tested (the fact that it was made, made it a fair target). – Christian Jun 20 '23 at 22:31
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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 Jun 21 '23 at 06:32
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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. – Sebastian Redl Jun 21 '23 at 10:43
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    @quarague : The whole argument as RFK makes it, is that the gold-standard for medical treatments is not followed for vaccines. The ethics of gathering information about safety are complex and on ethical questions different people can have different opinions. In any case, the ethics are separate from the question of what evidence we have about safety. If you take for example the Hepatitis B vaccine, it's not on the schedule in Denmark or Finland, so there would be no ethical reason not to run the trial over there. – Christian Jun 21 '23 at 11:10
  • It's not an opinion about medical ethics, it is medical ethics enforced by federal law. There's absolutely no reason to do a small clinical trial now that we have data from phase 4 (post approval) for hundreds of thousands of people. These vaccines were trialed before approval, found to be safe in the trials, and found to be safe in follow up surveillance. This is a complex problem distilled down to a simple soundbite as part of a gish gallop. – CJR Jun 21 '23 at 12:19