One of the cherished strategies of the antivaccine group is to quote vaccine package inserts (called a Patient Information Leaflet in EU countries and Instructions for Use in other cases) to “prove” that vaccines are dangerous.
Vaccine deniers consider the package insert to be golden tablets of the Truth™. It’s ironic that these antivaccine groupies rail against Big Pharma, as if they are demon reptilians, but the package insert, written by Big Pharma, is considered gospel. Irony abounds.
Just spend more than a couple of minutes in discussion in any vaccine “debate,” and you’ll eventually get someone pointing to a section in any of the many vaccine package inserts (PI) as “proof” that it is dangerous, contains dangerous stuff, or is just plain scary. Or that it doesn’t work.
Orac has recently proclaimed it “Argument by Package Insert”–it’s almost at the level of logical fallacy. (David Gorski has just given it the Latin name, argumentum ad package insert, so it’s now officially a logical fallacy.)
Before we start, vaccine package inserts are important documents, but only if the information included therein is properly understood. It is not a document that serves as medical and scientific gospel. But it is a document that can help clinicians use vaccines (or frankly, any medication) properly.
What is a Package Insert?
All of you have probably seen a package insert–it’s a multiple page document that is included with all real medications (as opposed to unregulated alternative medicine), whether prescription or over-the-counter (OTC). Depending on the type of drug, the PI can be 30-40 pages long, although most are printed on one huge sheet of very thin paper, so that it can be folded tightly and placed in each box that over-packages the drugs container (vial, bottle, etc).
Although some people believe it’s written in small fonts on thin paper to make it difficult to read and use, it’s actually done so to save on shipping costs. Yes, if you had to fold up a large font-size package insert and place it in each box that contains a vial or bottle of medication, the shipping weight and volume would make the cost astronomical. And that cost would pass down to consumers.
In general, package inserts are part of what is called the “labeling” of the drug, which means all the verbiage that pharmaceutical company may say about the drug. It is not just the printing on the vial or box, labelling encompasses almost everything said about the drug, including advertising, PI’s, and yes, the box and printing on vial.
You will hear FDA regulators and individuals in pharmaceutical companies refer to “labeling” all of the time. Labeling is strictly regulated, because it establishes the claims made about the drug or device, how it is to be used, and other pertinent information. Even what sales reps say to physicians in a sales call is covered by the drug’s labeling.
In the USA, the Food and Drug Administration has established very strict rules in the Code of Federal Regulations (CFR) on what can be and cannot be stated in the package insert. There is very little variance in format or quality of information from one PI to another one even for very different classes of drugs. Amusingly, the regulations even state the type and size of font used in the PI.