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Old 26-06-2018, 04:42 PM   #14
st jimmy
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Default Inappropriate placebos in vaccine trials

When I read that a medical study is double-blind, placebo controlled I’m almost automatically convinced that it’s a reasonably good study.
After I found out that in most vaccine trials, that claim to have used a “placebo” for controls, no proper placebos are used; I feel like a gullible fool...

In the first link are recommendations of the World Health Organization (WHO) to NOT use placebos in vaccine trials...

In short: the only medical vaccine trials in which a “placebo” can be used, is the situation that no appropriate existing vaccine exists for the specific disease.
This means that only when no vaccine exists for the disease a placebo should be used.

According to the WHO, it is unethical to conduct a proper placebo-controlled trial when already a “highly efficacious and safe vaccine” exists, because the participants in the study are deprived of the beneficial effects of the (already) existing vaccine.
So in these situations instead of a placebo a previously approved vaccine will be used.
According to the WHO, it wouldn’t be interesting to know the effects of the “new” vaccine compared to a placebo, but more relevant “how the new vaccine compares to the one that is currently in use".

In some situations, according to the WHO, “it may be appropriate to use a vaccine against a disease that is not the focus of the trial (e.g. an ongoing malaria vaccine trial provides non-malaria vaccines to participants in the control arm)”.
The WHO motivates this preposterous advice with to “avoid giving an injection with an inert substance”.
Obviously we can’t “waste” an injection to actually give a placebo (inert substance)…

It are the Research Ethics Committees (RECs) that enforce that no vaccine trials are performed with actual placebos.

Anette Rid et al – Placebo use in vaccine trials: Recommendations of a WHO expert panel (2014): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4157320/
(archived here: http://archive.is/NcK9e)


To NOT use a placebo (that’s actually inert) and then call it a “placebo” anyway in a medical trial should be a criminal offence...

The result is that every new version of a vaccine could be made with more adverse effects...
If the first version of a vaccine has only mild (insignificant) adverse effects, comparing the second version to the first, could mean that the adverse effects are insignificant compared to the first, but would be significant compared to a placebo.
The third version of the vaccine could be made even worse (while of course the medical quack doctors will advise that the newest version of the vaccine is clearly the best)...


If a “scientist” would want to compare the vaccine to a placebo, for example because the study (or studies) that led to the approval of the vaccine didn’t look into certain types of adverse effects; this would (per definition) be prohibited by the REC…
Because Gardasil and Cervarix are approved they could be used, according to the WHO guidelines, in following HPV-vaccine trials instead of a placebo. This makes it even more important that these vaccines are properly evaluated...

The following article presents some questions on the controversial human papillomavirus (HPV) vaccine Gardasil - 27 “little secrets” not known about Gardasil.
In my opinion it would be appropriate, to find out more about the (adverse) effects of Gardasil by a proper placebo-controlled trial.
Following is a list of some of the “secrets” not known about Gardasil.

1. Whether Gardasil prevents cancer
3. Whether Gardasil increases the risk of cancer.
Quote:
A May 2006 FDA VRBPAC document stated girls previously exposed to vaccine-relevant human papillomavirus and get inoculated with Gardasil have a 44.6% increase in getting cervical cancer in their life time.
5. Whether there is increased risk of autoimmune disorders due to the recombinant HPV DNA
6. If HPV is necessarily an infection transmitted by sexual intercourse
12. Long term serious side effects
13. What the results would be if a true placebo had been used in all the clinical trials
Quote:
The FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo. A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial.
http://offtheradar.co.nz/vaccines/29...e-secrets.html
(archived here: http://archive.is/joMG6)


There you have it: instead of a placebo they allowed the use of a “reactive aluminum containing placebo”. That’s a “placebo” with adverse effects...
Maybe I’m the only one to think that it’s bizarre that according to the WHO it is unethical to use a placebo when already a vaccine exists, because the participants would be deprived of the existing vaccine. But participants in vaccine studies are injected with “placebos” with “aluminium” with adverse effects.
To use a "placebo" with adverse effects should be a criminal offence...

So not only are inappropriate “placebos” used in vaccine trials when another vaccine for the disease had already been approved, but also when no such vaccine had already been approved!
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Last edited by st jimmy; 26-06-2018 at 05:00 PM.
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