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Discussion Starter · #1 ·
I have heard that many of the vaccine safety studies use false placebos -- ie the 'placebo' has the same adjuvants/preservatives without the active ingredient (the attenuated virus or whatever). Whereas a true placebo would be saline.

The papers that I have read (so far) do not elaborate on what is in the placebo, they just say placebo and assume the reader knows what that is.

Are there any sources that can verify this for me?
 

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I have heard that many of the vaccine safety studies use false placebos -- ie the 'placebo' has the same adjuvants/preservatives without the active ingredient (the attenuated virus or whatever). Whereas a true placebo would be saline.

The papers that I have read (so far) do not elaborate on what is in the placebo, they just say placebo and assume the reader knows what that is.

Are there any sources that can verify this for me?
A more common approach is to use another vaccine with an "established" safety profile as the "placebo."

One place to look at vaccine studies and placebos is the clinical studies database. https://clinicaltrials.gov/

hope that helps.
 

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It is true that often placebos are not just saline. But that doesn't mean they are false placebos. A placebo is a similar treatment that is inert (doesn't have the active ingredient being studied) and has an already tested safety profile. Placebos do not need to be a saline injection, or a sugar pill to be a placebo. It also isn't just vaccines where this is done, it is most research. A placebo doesn't have the active ingredient, because that is what is being studied for safety and for effectiveness, what is in the placebo should have already been through similar testing for safety.
 

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Discussion Starter · #4 ·
Thanks for the link Deborah

It is true that often placebos are not just saline. But that doesn't mean they are false placebos. A placebo is a similar treatment that is inert (doesn't have the active ingredient being studied) and has an already tested safety profile. Placebos do not need to be a saline injection, or a sugar pill to be a placebo. It also isn't just vaccines where this is done, it is most research. A placebo doesn't have the active ingredient, because that is what is being studied for safety and for effectiveness, what is in the placebo should have already been through similar testing for safety.
Ok that makes sense... that way the researchers know that any difference in outcome is due to the active ingredient.

Have the other ingredients been through testing for safety?
 

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Thanks for the link Deborah



Ok that makes sense... that way the researchers know that any difference in outcome is due to the active ingredient.

Have the other ingredients been through testing for safety?
The ingredients of vaccines are discussed here. http://www.cdc.gov/vaccines/vac-gen/additives.htm

This is a discussion forum composed of community members. We may be able to help you find references, but are equipped to get you opinions more often than facts. If you have health concerns you should consult your provider.
 

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Thanks for the link Deborah



Ok that makes sense... that way the researchers know that any difference in outcome is due to the active ingredient.

Have the other ingredients been through testing for safety?
Ideally yes. I say ideally because thorough is hard to define. it is theoretically possible that saline could be unsafe for someone too. But in general yes. Placebo pills aren't always just sugar pills either, just not containing the active ingredient being tested as has been the protocol in experimentation.
 

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This is an 'interesting' article on the use of placebos in research: http://www.bonkersinstitute.org/rat.html
The general public has come to expect that any drug approved by the FDA will work better than a placebo sugar pill. This expectation seems perfectly fair, reasonable, and not too much to ask, but the average citizen lacks the sophistication to understand the heavy burden such an expectation places on the pharmaceutical industry, diverting scarce resources away from advertising, promotion and public relations into less cost-effective sectors such as laboratory testing, analysis and record-keeping.
 

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I have heard that many of the vaccine safety studies use false placebos -- ie the 'placebo' has the same adjuvants/preservatives without the active ingredient (the attenuated virus or whatever). Whereas a true placebo would be saline.

The papers that I have read (so far) do not elaborate on what is in the placebo, they just say placebo and assume the reader knows what that is.

Are there any sources that can verify this for me?
What papers are those? I am not familiar with any vaccine studies that involve placebos I only know that vaccines are tested against other vaccines.
 

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I did a brief search last night when I first read this thread. I found several papers which listed normal saline as the placebo. I also found some which didn't specify (which is poor reporting IMO) and some which didn't specify in the abstract and didn't have the full text available free so may or may not have identified it in the full text.


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I'm not going to provide references, but this is what I remember on specific situations with specific vaccines.

Gardasil was tested against two placebo groups: The large placebo group got a shot containing aluminum at the same level as the vaccine, the small placebo group (300) got saline. For mild reactions they were separated in the study, for serious reactions they were combined.

At least one of the rotavirus vaccines was compared to a placebo that contained everything except the antigens. The problem with this is that the vaccine is made with fetal bovine serum. According to a friend who has worked in the field of vaccines, FBV, due to it being extracted from live animals under slaughterhouse conditions, is frequently contaminated. Therefore you can't predict what babies are being exposed to, therefore you cannot predict possible reactions to either the placebo or the vaccine.

Finally, the original Prevnar vaccine (Prevnar 7) was compared to an experimental vaccine. Nope. Not making that one up. I can find the link if anyone expresses disbelief.
 

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According to the WHOs "Expert consultation on the use of placebos in vaccine trials" written in 2013:

"Consideration about the types of potential placebos should be included in the broader discussion on trial design. A true placebo is an inert substance, but in the context of vaccine research, the term placebo is also applied to other types of comparators that are not inert, but are not expected to protect against the disease of interest in a vaccine trial."

In other words, a placebo is a linguistic term for any substance similar to the vaccine being tested, but that would not protect the body against a disease. Another vaccine, parts of the vaccine, etc. would all be a placebo under this definition.

This is quite a broad definition. For the clinical trials of various vaccines, I think you would have to go through each paper and see exactly what was used. Sometimes it is not stated out right, but instead found in a footnote. The term placebo is used regardless of whether it is a "true" placebo or not.
 
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