Antivax Trick #5: Why Did They Remove Section 13?

Antivax Trick #5: Why Did They Remove Section 13?

The argument goes that pharmaceutical industries removed section 13, which talks about mutagenicity and other topics, from some vaccine inserts in order to hide something from the public.

The argument also implies they did so in such a clumsy manner, they forgot to reorder all the items after it

These scare tactics also leave out the manufacturer's own note below that

So from the start, let's acknowledge it's not really a cover up if they go out of their way to let you know they omitted it and why. I will grant to you that it's strange form of documentation. As with any dense federal documentation, it can be hard to follow. In any case, the truth is sometimes more boring than the conspiracy.

In the Electronic Code of Federal Regulations §201.57 (Specific requirements on content and format of labeling for human prescription drug and biological products described in §201.56(d)(4)), it states

(4) Omit clearly inapplicable sections, subsections, or specific information. If sections or subsections required under paragraph (d)(1) of this section are omitted from the full prescribing information, the heading “Full Prescribing Information: Contents” must be followed by an asterisk and the following statement must appear at the end of Contents: “* Sections or subsections omitted from the full prescribing information are not listed.

Omitting sections in package inserts is pretty rare. In the case of Pneumovax, including section 13 to say it wasn't tested for carcinogenic and mutagenic effects sounded like it implied it left the door wide open for that.

In fact, the makeup of the vaccine's potential for these effects was nonexistent and the requirement for these tests was unnecessary. Hence no section 13.

More information on Antivaxxer's beloved package inserts

The takeaway from Package Inserts is they are as accurate as they are weirdly written because they serve more as legal documentation than they do a scientific analysis of the product.

And let us remember that the lack of evidence is not evidence.

We have not looked into whether these bananas will cause cancer!

This of it this way, if grocery stores put signs on their bananas saying "These bananas have not been tested for carcinogenic nor mutagenic effects," it makes people think, "hey, they might have carcinogenic or mutagenic effects!" Yet we communicate this more clearly by just not putting up the sign in the first place. It's not necessary.

See the entire series

Common Data Manipulations of Antivaxxers
This post serves as an index of our “Antivax Trick” series showcasing common copy-and-paste arguments shared amongs the antivax community 1. Vaccines are killing and injuring people [/evidence-vaccine-injury-is-almost-nonexistent/] 2. Measles declined before the vaccine [/antivax-trick-2-…
Adam Grant

Adam Grant