There are no vaccine studies with saline placebo?

Are there really no vaccine studies done with a saline placebo? This is a common comment from antivaxers. They think vaccines cannot possibly be safe unless they are tested against an inert substance, aka the saline placebo, and there are none in existence. Therefore, vaccines are BAD.

 

saline-di-trapani

What is a placebo and what is a saline placebo?  A placebo is a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect. Saline is something impregnated with salt. A saline placebo is basically a dose of salty water in lieu of a drug. So, the idea is that one group of study participants should get the vaccine while the other groups has a shot of salty water and neither group knows who got which. This is what is meant by double-blind, saline-placebo.

The World Health Organization has a great document explaining how placebos work and why certain substances are chosen for vaccine trials.

“Randomisation and the use of placebo interventions are designed to control for confounding effects, such that significant differences in disease incidence or adverse effects between the vaccine and control groups can likely be attributed to the vaccine. However, randomised, placebo-controlled trial designs often raise ethical concerns when participants in the control arm are deprived of an existing vaccine. Furthermore, testing a new vaccine against placebo is scientifically and ethically fraught when the hypothesis being tested is whether an experimental vaccine is more efficacious than one already in use in the same or in other settings.”

WHO goes on to detail how it may be unethical to deprive a study participant of a vaccine when an efficacious one exists. Meaning, if they are testing a new vaccine it would be unethical to test it against saline when an older, proven safe version exists. So, they can use the older version as the placebo and, therefore, not deprive the study participant of the protection. It is also considered ethical to use an adjuvant in lieu of a vaccine when the vaccine being studied has that adjuvant in it. So, you can use an aluminum adjuvant as a placebo if the adjuvant has been around enough to have been studied for safety. This is a controversial topic, with some feeling that aluminum adjuvants don’t have a proven safety record to use as a placebo.  That is a topic for another blog post. This one is focused solely on saline placebo.

“Between these two poles, the use of placebo controls in vaccine trials may be justified even when an efficacious vaccine exists, provided the risk-benefit profile of the trial is acceptable. “

The rest of the document sets out a “framework sets out the conditions under which placebo use is clearly acceptable and clearly unacceptable in vaccine trials.”

That being said, this does not mean there are no vaccine studies which use a saline placebo. Many clinical trials use a saline placebo. Read inserts to learn more. And, PubMed, the online database of scientific studies organized by the USA’s National Institutes of Health, has many listings for vaccine studies which use a saline placebo.

Here are some vaccine studies which used saline placebo:

https://www.ncbi.nlm.nih.gov/pubmed/25371534
https://www.ncbi.nlm.nih.gov/pubmed/29443825
https://www.ncbi.nlm.nih.gov/pubmed/29239682
https://www.ncbi.nlm.nih.gov/pubmed/29217375
https://www.ncbi.nlm.nih.gov/pubmed/28720281
https://www.ncbi.nlm.nih.gov/pubmed/28522338
https://www.ncbi.nlm.nih.gov/pubmed/28498853
https://www.ncbi.nlm.nih.gov/pubmed/28376743
https://www.ncbi.nlm.nih.gov/pubmed/27895921
https://www.ncbi.nlm.nih.gov/pubmed/26411885
I could go on. This was from only the first two pages of my PubMed search.

 

So, as you can see, there are very important reasons why a scientist might not use a saline placebo in a vaccine study but there are also many vaccine studies which do use a saline placebo. As usual, antivaxers are conveying misinformation. In fact, my online friend, Mike, came up with this and I turned it into a meme. This is exactly what they do, goal shifting!

no true scotsman

 

Remember to always verify claims!

 

Kathy

This post is dedicated to Bernadette for always giving me great ideas for blog posts

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50 thoughts on “There are no vaccine studies with saline placebo?

  1. Pingback: Antivaxers bring up Hannah Poling and vaccine safety, AGAIN | vaccinesworkblog

  2. Consider the problem is with the toxic ingredients like Aluminium in the adjuvant.
    I looked at the first link:
    https://www.ncbi.nlm.nih.gov/pubmed/25371534 – a randomized, placebo-controlled study ON ONLY HIV positive and all under Antiretroviral therapy, tested with a live vaccine (no adjuvant was described in the abstract).

    The second one:
    https://www.ncbi.nlm.nih.gov/pubmed/29443825 – Is for pre-natal flu vaccine and is unclear if of the 19,000 potential infants, in the control groups, recieved any vaccines after birth.

    The third one:
    https://www.ncbi.nlm.nih.gov/pubmed/29239682 – Is a live vaccine with no mention of any adjuvant.

    I quit researching after that.
    From the first three studies I have 0% confidence that vaccines with adjuvants have been tested against a saline placebo.

    Like

  3. I had to look that up, scotsman fallacy. I didn’t exclude anything, I looked at the first three. So let’s have a look at the next three.

    https://www.ncbi.nlm.nih.gov/pubmed/29217375 – This one does have a vaccine adjuvant versus a saline palcebo yay!!! Oh, only 68 participants! Sorry, the sample group is too small, otherwise I would have accepted this as conclusive. Furthermore this is a study of a single vaccine over a 57 day period. In the real world we are concerned about the general health outcomes over a longer time-span and multiple vaccines with adjuvants.

    https://www.ncbi.nlm.nih.gov/pubmed/28720281 – Also a good study, a decent sample size of 420 , but no Aluminium adjuvant. The adjuvant was vitamin E and squalene.

    https://www.ncbi.nlm.nih.gov/pubmed/28522338 – Wow. No adjuvant mentioned, but wow, in the adverse events section, while the heatlh outcomes of the placebo group were not very different from the vaccine group they were worse for vaccines in every category except one. Deaths of infants in the palcebo group 50, versus 61 in the vaccine group, a 0.61% higher risk of death. I wouldn’t push that one as a pro-vaccine study. Would you give your kids this vaccine?

    Four more to go. Thanks for this engaging blog.

    Liked by 1 person

    • You posted on a blog post where I explain the no true scotsman fallacy and you had to look it up?

      You are posting on a study discussing how antivaxers think there are not vaccine studies with saline placebo. But, they are wrong.

      Do you have a point here? Because the main point of my blog post is that there are studies with a saline placebo. End of story. Period. Nothing more.

      Like

  4. If you want to go after people that say there are no saline placebo comparative studies, fine, there is clearly there an education gap, okay. Most people don’t understand the science of placebos and they have heard something that has grabbed their attention. So let’s help them out and suggest an area of study that may be missing placebo’s from vaccine safety studies. The aluminium hydroxide adjuvant versus placebo study. Can you find that one?

    Liked by 1 person

  5. I am sure you are aware that the hypothesis of toxic build up in the brain is a valid one, be it mercury, aluminium or any known neurotoxin that can be found in vaccines, foods, tooth fillings, light bulbs etc. Chris Exleys work on Aluminium, (which has set benchmarks in previous studies) finds higher levels of Aluminium in Alzheimer brains. Which you know about, and don’t bother pointing me to your pals over at skepticalraptor.com , they failed to notice previous studies of Aluminium and focus on Exleys one work as if it is the defining comaprative study, which it is not. It is a study, not a comparison. Comparisons are against previous studies, but oh, they are closed for comments. There may be a number of causes of Autism Spectrum Disorders and where we know there is a potential for triggering it through toxic overload then it would be really helpful to develop a screening process to help parents rule out a toxic overload risk. It would also help parents to attempt ASD reversal by the method mentioned by Exley, increasing silicates in the diet. Your kids may be unaffected by vaccines because they already have a high silicate diet. Call it a Scotsman fallacy if it makes you happy. I cant’ help thinking it is better to look in to every potential cause for an adverse reaction rather than to exclude one source of neurotoxins, vaccines.
    It is important to research exactly why vaccines are unavoidably unsafe, be it neurotoxicity or allergic reactions. Who knows, a few hundred kids could already have had their ASD diagnosis reversed simply by changing diet after their environment made them hypersensitive or overloaded with toxins?

    The problem with this website is that you make an assumption that there is nothing wrong with vaccines, when we know they are unavoidably unsafe. If you took the line of looking in to every possible cause of their unsafeness it may show help to reveal oddities like changes in diet can reduce ASD.

    Liked by 2 people

    • No where in that wall of text is any real evidence that is more harm from the vaccine when compared to the disease. In no paper has Exley shown aluminum causes more harm than the diseases.

      His paper, paid by the Dwoskin family, looking at just five brains of dead people with claims that they were high in aluminum and all had autism was very silly. There were from brains of people who died between age 15 and 50. There were no controls. Plus the methods to access the amount of aluminum was wonky:
      https://scientistabe.wordpress.com/2017/11/27/neurosciences-aluminum-does-the-latest-paper-from-exley-show-a-link-between-asd-and-aluminum/

      Autism is not a death sentence. Please stop claiming autism is more horrible than a child suffering from pertussis, diphtheria and tetanus. This claim shows that you do not respect people with genetic disabilities.

      “It is important to research exactly why vaccines are unavoidably unsafe, be it neurotoxicity or allergic reactions”

      That is always being done. There is a reason the IPV is used instead of OPV, the DTaP replaced the DTP, a new safer rabies vaccine was introduced in 1968 and the first rotavirus was replaced by newer versions. You seem to be invoking the Nirvana fallacy

      Liked by 1 person

    • Exley’s work has been debunked over and over. His work is rife with conflicts of interest and bad analyses. He averaged the data from his autism aluminum brain data. Bad science!

      Tell me, which of the brain samples in Exley’s autism brain aluminum study were vaccinated?

      Liked by 1 person

      • That was one of the worst articles I’ve ever read on this topic. You’re gonna need to do your homework and provide a valid double blind, placebo controlled study using saline on infants…in the United States, and for longer than a few months. That’s actually laughable to post a study with that short of a time frame. The antivaxxers are concerned with childhood vaccines in the majority of cases and then you come on here and post the majority of studies that were done on adults and the others were in other countries. You’re not going to be taken seriously unless you can back up your claims of valid studies and provide at least one. A study done on 60 subjects for 6 months is a joke. If you worked for the NIH your grant money would disappear pretty quickly. I’ll be waiting for that study on infants using a saline solution in the U.S. Do a little homework this time though. and provide your facts based on scientific studies.

        Liked by 2 people

      • Joe (or is it John?): “You’re gonna need to do your homework and provide a valid double blind, placebo controlled study using saline on infants…in the United States, and for longer than a few months.”

        I am sorry, but you are the one that needs to do your homework. If you are not satisfied with the several large epidemiological studies on several hundreds of thousands of children in several countries: then do it yourself.

        Design a study, making sure it complies with the Belmont Report. Get it approved by an independent review board (none of them should be your relatives), and then write a grant to get it funded. Submit the grant to folks like SafeMinds, Generation Rescue and the Dwoskin folks. Then get it done.

        Come back after you have published in a PubMed indexed journal.

        Liked by 1 person

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  7. Pingback: Zwölfter Teil III – -Aluminium und das Immunsystem – Ganzheitlich Durchleuchtet

  8. Pingback: Where are the Saline Placebos? – VAXOPEDIA

  9. So I have a very simple question.

    The original gardasil series states they used a saline placebo but when a medical professional friend of mine bought the research paper and read it he found out that the saline placebo was spiked with L arginine. Why would a saline placebo be spiked with a substance that can cause reactions in the body?
    https://www.medicalnewstoday.com/articles/318174.php

    Thank you

    Tara

    Like

  10. Thank you for getting back to me.
    I have to correct myself.

    It was actually L.histidine.

    Here in this video they go through everything but when they specifically mention this “saline placebo” used during the clinical trial of gardasil and what was a in it is at 30:23 into the video.

    I realize it is Dr. Suzanne Humphries and that she is considered a “quack” but I have checked her credentials and she is a board certified nephrologist so I’m sure she knows how to read these documents.

    So what I’m wondering is if Merck could get away with flat out lying about what their “saline” was is it possible that other studies have done the same?

    Is there a way for the general public to access the detailed information Dr. Humphries obtained in this video? Are you able to go and fact check her information?

    I mean, really, it is quite alarming to me that something used in a clinical trial, stated to be saline is actually NOT saline. How do we trust these “saline placebo” controlled studies for immunizations?

    Is it really that easy to commit scientific fraud? Are the salines used actually confirmed to be saline by those approving these products or do folks at the FDA just take their word for it?

    Thank you again for your time. I’m simply trying to figure this all out.

    Cheers,

    Tara Reeve

    Like

  11. I would like you to ask yourself why a vaccine needs to be tested against a saline placebo and why another inert substance is not acceptable? Is it because Suzanne and Del told you so? Why not read what the World Health Organization says about placebo use in vaccine trials.

    “Randomised, placebo-controlled trials are widely considered the gold standard for evaluating the safety and efficacy of a new vaccine. In these trials, participants are randomized to receive either the vaccine under investigation or a placebo (i.e. an inert substance, such as a saline injection). Randomisation and the use of placebo interventions are designed to control for confounding effects, such that significant differences in disease incidence or adverse effects between the vaccine and control groups can likely be attributed to the vaccine. However, randomised, placebo-controlled trial designs often raise ethical concerns when participants in the control arm are deprived of an existing vaccine. Furthermore, testing a new vaccine against placebo is scientifically and ethically fraught when the hypothesis being tested is whether an experimental vaccine is more efficacious than one already in use in the same or in other settings.”

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4157320/

    So, why do Del and Suzanne ignore this information? Why is their word better to you than that of every scientific and medical organization on earth?

    And why do you focus so much on the trials by Merck and not the studies were done in Australia done by the inventors of the HPV vaccine?

    Why do you think this is fraud, other than Del and Suzanne say so? Because literally every single scientific and medical organization on earth says Del and Suzanne are wrong. Why are you their side and not the side of science?

    I appreciate that you are trying to figure this out. This is a great website to find HPV vaccine safety information

    http://www.kegel.com/hpv

    My friend Michael, the Skeptical Raptor, also has written a great deal on HPV vaccine. I would encourage you to visit his website and learn. Search for HPV and you will find many articles.

    https://www.skepticalraptor.com/skepticalraptorblog.php/

    My friend Abe as an outstanding blog wherein he explains about aluminum. He is known as the blood brain barrier scientis.

    https://scientistabe.wordpress.com/

    Like

  12. Well I believe the reason why it seems prudent to test against a saline placebo is to determine the correct percentage of individuals that have adverse reactions.
    Why is it only about efficacy?

    I’m not putting more merit in what anyone says I’m only trying to understand why something would be stated to be saline during a clinical trial when it clearly was not.

    And again, if one study using a supposed saline wasn’t actually a saline how is one suppose to know if those other studies are actually using saline or not?

    I’m not anti vaccine. I’m pro choice for pretty much anything parenting related.
    I’m also just trying to understand the reasoning behind doing something like this.

    That is all.

    Liked by 1 person

    • In all phases of clinical trials, safety is always examined. Phase 4 post-marketing (usually large observational studies) are the studies that look for rare events. If at any point, the drug, device, intervention, etc. is judged by an independent safety monitoring committee to pose a risk that exceeds the benefits (think chemotherapy that can be toxic but is deemed to be worth the risk), the trial is halted. Most drugs never come to market because they can’t either can’t demonstrate efficacy or have an undesirable safety profile. It’s a pretty complex process but they don’t wait until the end of a trial to look at the safety. The safety boundaries are set prior to the trial. For rare events detected in post-marketing surveillance (Phase 4), drugs (devices, vaccines, interventions) may be removed from the market, black-boxed, or replaced by drugs with better profiles. People forget that researchers and healthcare providers are healthcare consumers too. We want our medications, devices, and vaccines to be as safe as possible and effective. I am an epidemiologist with formal education and experience in clinical trials. It’s up to the pharmaceutical companies (who employ their own epidemiologists) to prove efficacy and safety but the non-industry epidemiologists make their careers looking for adverse events. We can also lose our jobs/careers by committing fraud. And those who do commit fraud, should be prosecuted (shot? maybe a little harsh but it’s a pretty serious offense). Here is a video that explains the main phases of clinical trials. https://www.fda.gov/forpatients/approvals/drugs/ucm405622.htm. I hope this helps!

      Liked by 3 people

  13. I don’t think the question is “Why aren’t we testing old vaccines against saline placebos?” (which would require depriving half the participants of an existing vaccine), but “Why were new vaccines never tested against saline placebos when they were new?” (which does not deprive participants of an existing vaccine).

    Can you shed light on why, for instance, 9-valent HPV wasn’t tested against inert placebo right from the start, instead of waiting until the 4th dose for the participants (as the last link in your list shows)?

    Second, can you point us to some of the placebo-controlled trials on *children’s* vaccines? All in your list are for vaccines given to adults, except for the aforementioned HPV vaccine trial (which automatically excluded anyone who had serious AEs to previous doses). It’s clear there are many for adults, but I haven’t been successful in finding any others for children’s vaccines.

    Liked by 1 person

    • Here is some reading for you.

      “Gardasil was assessed in Double Blind Randomised Placebo Controlled Trials that used the fully formulated vaccine and compared it with two different placebos, the aluminium adjuvant and a saline solution.

      What is a placebo?
      A placebo is a substance as similar as possible to the active drug except it has no therapeutic effect. It does not need to be ‘inert’. The best placebo is one that mimics the active therapy as much as possible. This is because the ‘placebo effect’ is a powerful phenomenon and to truly measure the effect of an active product it important that all recipients are equally as likely to think they received the “real deal’.”

      https://sciblogs.co.nz/diplomaticimmunity/2017/02/20/gardasil-vaccine-compared-placebo/

      Here is a summary of clinical trials for 9-valent HPV vaccine. As you can see, there was one clinical trial with saline placebo.

      https://pediatrics.aappublications.org/content/138/2/e20154387.full

      Thus, your assertion that new vaccines are not tested against a saline placebo is untrue. Furthermore, if you read the World Health Org document linked in my blog post, you will learn why saline placebos are not necessary for all vaccine trials.

      As for saline placebos with children,

      “In fact, the American Academy of Pediatrics (AAP) in its “Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations” specifically states, “In general, placebos should be used when data cannot be obtained by comparing the efficacy and safety of the drug under study with either a commonly used therapeutic agent for that condition or the natural course of the disease as described from clinical studies.” [8] The AAP guidelines list five situations when placebos in pediatric research are ethically acceptable. These include (1) when no intervention is currently accepted, (2) when the current intervention lacks proven benefit, (3) when the current intervention is unsafe, (4) when the addition of the proposed therapy to a standard therapy might prove unsafe, and (5) when the course of the condition under treatment varies widely in severity in a given individual.”

      https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2831649/

      As the article goes on to state, when there is an acceptable comparator, such as an already well-used adjuvant or an already existing vaccine, it is better to use that as placebo than a saline placebo.

      Liked by 1 person

  14. Can you please provide information on a study that was double blind placebo with saline solution, where the control group was NOT previously vaccinated. I’m talking about a clean study where the control was not subjected to any related, previous, or similar vaccines, and was also healthy.

    Like

    • Sure, right after you tell us how many classes in statistics and epidemiology that you have taken, with an explanation how a study like that can be done and still be in compliance with the Belmont Report.

      In the mean time, while you are gathering that information, please read this blog article: http://www.docbastard.net/2019/03/busting-vaccine-myths.html

      Now, tell us in your own words what it says in the paragraph that starts with “25) But there is no true study of unvaccinated vs vaccinated children!”

      Liked by 1 person

      • I’d like John to list a single vaccine-preventable disease (with citations) that doesn’t have serious mortality or morbidity implications.

        Liked by 1 person

      • That is the special thing about his kind of thinking. Apparently vaccines are dangerous, and the actual diseases only cause a mild illness for just a few days. In their world, Htrae, the only ones who suffer from Hib, measles, pertussis, tetanus, etc were undernourished and deserve their fate.

        Did you hear about this poor child: https://www.oregonlive.com/clark-county/2019/03/rare-case-of-oregon-tetanus-required-care-of-100-doctors-nurses.html

        The parents still refused to vaccinate their kid.

        Like

      • I should add that in our local newspaper there was a report on the Clark County outbreak. One person responded that he had measles, which only produced a few spots and all was well after three days. To me it sounds like Fifth Disease or someone with a faulty memory.

        I responded with the actual risks and side effects of measles (pneumonia, encephalitis, depressed immunity for years, SSPE and the actual risk of death from the CDC).

        His response was that I was a troll. How droll.

        This is what one has to deal with from the residents of Htrae, also known as Bizarro World where everyday is opposite day.

        Like

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  16. Pingback: Impfen Pro und Contra - 12 - Teil III - "Aluminium und das Immunsystem" - Eingeimpft

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