The one vaccine clinical trial design to rule them all

If you spend time observing the “vaccine debate” (it’s not a debate), you’ll hear every dumb argument to deny science. But one thing that you’ll see repeatedly from the antivaccination cults are that they would support vaccinations if there were better vaccine clinical trial design.

The problem with the cult’s demand for better vaccine clinical trial design is really one of several moving targets for their denialism, relying on a form of the Argument from ignorance, claiming that if we can’t absolutely “prove” that vaccines are safe, then it must be absolutely unsafe.

For example, there are literally thousands of articles,  ( an example here and was discussed here), that actually provide overwhelming evidence of the safety and effectiveness of vaccines using real science, real statistics, and real hard work. The antithesis of the fake science, bogus statistics, and 2 hours of Google.

One vaccine clinical trial design to rule them all

 

The actual process for vaccine clinical trials.
The actual process for vaccine clinical trials.

My good friend Allison Hagood, co-author of Your Baby’s Best Shot: Why Vaccines Are Safe and Save Lives, wrote a commentary about the antivaccine community’s perfect clinical trial. Follow along! (Editor’s note: Allison’s commentary is presented in whole, but I’ve edited the formatting and added links where necessary).

Why the anti-vaccine movement doesn’t really understand science

 

Multiple studies in multiple countries using multiple research models and multiple research groups, with multiple funding sources, have found no link between vaccines and autism. This is also true for a link between vaccines and ADHD, asthma, diabetes, autoimmune disorders, and the various other conditions that antivaccine cult has attempted to link to vaccinations.

Every one of these scientific studies has been dismissed by the vaccine deniers as having the wrong funding source, the wrong research design, the wrong focus, not separating out antigens from other vaccine ingredients, separating antigens from other vaccine ingredients inappropriately, not testing this, or that or something else.

The antivaccine movement wants ONE study. The One Study To Rule Them All. The One Study that tests every possible aspect of every vaccine.

 
 

So what is this one study?

 

This is basically what the antivaccination cult is asking science to do:

  1. Eliminate the use of all vaccines immediately in every country on the planet. Immediately. Regardless of any public health issues currently in existence.
  2. Randomly sample an acceptable number of children for each experimental and control group for each group discussed below.The numbers in each group would need to be in the hundreds or thousands to satisfy statistical requirements for validity and significance, and would have to include children from every country, every ethnicity, every socio-economic status, with every possible genetic combination from parents, and of every possible health history based on parental family health.Antivaccine cultists have rejected studies with 3000 or more subjects, so each group below would need to contain huge numbers in order to satisfy them. But then again, many of them accept 12 subjects (the number in Andrew Wakefield’s fraudulent study) as valid, so who knows?Antivaccine propagandists are fond of saying “there are plenty of unvaccinated kids already, just use them!” You cannot use pre-existing groups who selectively vaccinate or do not vaccinate at all, because research has shown that these parents have certain differences from other parents, and those pre-existing differences would be a confounding variable in the study.To do a credible study of the kind that the anti-vaccine propagandists are demanding, you MUST randomly sample children, and then you MUST randomly assign them to the groups below. Parents would have no choice about this.
  3. Obtain permission from parents of children in each group to administer an injection into their child. The parents and children will not know what injection the child is receiving. The parents would not be allowed to have their children receive any injection from any other source, to avoid contamination of the data. Some children in the study would be completely unprotected from any disease outbreak, and their parents would be unaware of whether or not the children were unprotected.
  4. The injection received may contain any of the following configurations:
    • Just the antigen, in saline.
    • Just saline. This comparison (or control, in scientific terms) group would be necessary for every single group involved in the study. No one in this group would receive any aspect of any vaccine ever, just injections of saline.
    • Just one ingredient of the vaccine (i.e., formaldehyde), in saline.
    • Two or more of the ingredients, in various combinations (i.e., formaldehyde and the antigen, formaldehyde and the aluminum salts, the antigen and the aluminum salts, etc.). For example, according to the CDC pink book, the MMR-II vaccine contains these ingredients (pdf):-Vitamins–Amino acidsFetal bovine serum

      Sucrose

      Sodium phosphate 

      Glutamate (an amino acid)

      – Recombinant human albumin

      Neomycin

      Sorbitol

      Hydrolyzed gelatin 

      Chick embryo cell culture

      WI-38 human diploid lung fibroblasts

    • So, starting with the first ingredient on the list, we’d have to have a group that received every single vitamin injected, every single vitamin in combination with every single other vitamin, in combination with multiple of the other vitamins, etc. Let’s say there are four different vitamins (A, B, C, D). We’d have to have an A only group, a B only group, a C only group a D only group, an A/B group, an A/C group, an A/D group, a B/C group, a B/D group, a C/D group, an ABC group, an ABD group, an ACD group, a BDC group, and an ABCD . That’s 15 comparison groups for four ingredients.
    • Then, we’d have to have a group for each vitamin in combination with each other ingredient – vitamin A combined with sucrose, B with sucrose, D with sucrose, etc. Then we would have to test each other ingredient in various combinations with other ingredients. Again, thousands of groups, each having hundreds or thousands of children to cover all combinations mentioned above.
    • The above breakdown of possible combinations would have to be repeated for every vaccine, for every booster, and for every possible combination of boosters.
    • Follow every single child in every single group throughout the course of their entire lifetime (which, with current life expectancy, can be 70-80 years in developed countries), monitoring every medical/health condition that develops, and comparing those rates for each and every group above. If a single of the thousands of study groups lost a single participant (through moving, withdrawal, death, etc.), the Avers would declare the entire study null and void, even though such attrition is to be expected, and is controlled for in the study design.
  5. Compare each group above for every possible illness or medical/health condition.
  6. For each and every group mentioned above, we’d have to create a control group in which the children received no injection at all, of anything. No saline, no antigen, nothing.
  7. Remember that the anti-vaccine movement wants each vaccine tested individually, THEN in combination. So, we’d have to have one generation of children receiving the above breakdown of ONE vaccine over an entire lifetime, then another generation of children receiving the above breakdown of ANOTHER vaccine over an entire lifetime, etc., until all vaccines have been tested individually. Then and only then do we start testing vaccines with boosters. Then after that, vaccines in combination, but only two at a time. Then three at a time. This requirement would mean that the study that would fit the criteria demanded, the One True Study, would last until approximately the heat death of the sun.
  8. This doesn’t even get into the ethics of the various groups, the sampling difficulties, or the enormous amounts of money that would be required (money that could not come from any government, any governmental agency, any institution of higher education, or any scientist who’s ever done vaccination research in their career).

At this point, it should be apparent that such a study is not possible. The beauty of good scientific clinical research is that it answers one question at a time, that it limits harm to patients, and that the time to get an answer is relatively fast.

The proposed research of the antivaccination cult is simply not necessary.

Conclusion, the TL;DR version

 

  • The one vaccine clinical trial design to rule them all is overly complex and highly unethical.
  • It would require a biased design, since one group would opt out (both parents who would never put their children at risk of not getting vaccines against diseases). Another would opt-out because of their scientific ignorance thinking that the 50% chance of not receiving a placebo is dangerous.
  • Various studies have addressed various aspects of each of the embedded questions in the above scenarios, and in combination, those answers address the concern of the anti-vaccine movement. For example, one ingredient used in vaccines are aluminum salts (not elemental aluminum, as is claimed). These are used as an adjuvant, to create a stronger immune response so that less antigenic material is required. The safety of these adjuvants has been well established. That’s just one meta-analysis of the studies of the safety of one ingredient. It’s not part of The One Study that anti-vaccine propagandists want, though, so they reject it.
  • Think of the studies as a jigsaw puzzle. The puzzle isn’t one piece. It’s many pieces that fit together, making a total picture. The total picture on vaccinations is that they are safe and save lives.

Editor’s note: This article was originally published in April 2013. It has been completely revised and updated to include more comprehensive information, to improve readability and to add current research.

Key citations

 

The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!
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  • I’m enough of a dick to tell the anti-vax loons, “Sure, we’ll do your study, just volunteer your kids, you can even pick for them to not have the vaccines,” and then vaccinate the kids anyway. Feck it: If they’re too stupid to want to keep their kids safe, I’m evil enough to do it for them.

  • kfunk937

    My favourite line is

    This requirement would mean that the study that would fit the criteria demanded, the One True Study, would last until approximately the heat death of the sun.

  • Ha. An even nicer listing of why the “vaxed”/”unvaxed” study is both unethical and impractical.

    https://www.sciencebasedmedicine.org/the-perils-and-pitfalls-of-doing-a-vaccinated-versus-unvaccinated-study/

    Of course, add to that the occasional addition of new vaccines to the schedule, and there’s be no chance that such a design as what you describe could ever be done, as it would be far too expensive, completely impractical, and unethical to boot.

    • JaneCDonaldson

      ✸✸✸✸✔✸✸✸✸✔ $83 /h0ur @mi30//

      ➨➨➨http://CybereOrganizationEco.com/division/finance

    • We could have an infinite number of variables, requiring every human being on the planet to participate in the trial. Who’s going to pay for this trial? What super computer is going to be able to do all the cross-tabs, statistical analysis, and have someone review it.

      This will be fun!