Vaccine skeptics’ obsession with drug package inserts

I occasionally dip my toe into the constant internet flame wars over what the generous term vaccine skepticism, the less generous vaccine denial. If you’re looking to see one of these quickly, Twitter always has some ongoing vaccine fireworks. The character limit of Twitter tends to compress the exchanges into hurled invectives, only occasionally punctuated by futile pleas for calm. Many quickly devolve into exchanges between posters of what they believe to be crushing evidence in the form of an image or two.  A huge variety of message boards and blog comment streams can be just as vitriolic and the posters are not confined to 140 characters. It’s a swamp, but it can be a fascinating swamp. Of course full disclosure requires I say I am a stout defender of vaccine efficacy and safety, which is not surprising since I am a pediatrician with subspecialty training in infectious diseases and critical care. One particular talisman vaccine skeptics (I’ll be kind here) obsess over is the package insert found in the vaccine boxes. I’m often challenged on Twitter with an image of one and told to “read the insert, stupid.” Here’s a fairly benign example of what one sees:


That one’s just kind of ominous. There are plenty more that make it sound as if vaccines are highly dangerous — if you just read the insert. Here’s what can easily result:


Are you terrified yet? No? Well, if you’re not, perhaps it’s because you have a broader understanding of what drug package inserts are and how they got there. The inserts are produced by the manufacturer of the drug and they have long been required by the FDA to include them. Every drug has them, and you can actually see a huge compendium of what’s in them by referring to a book that has been around for many decades: the Physicians Desk Reference, or PDR. For many years every licensed physician received these huge tomes in the mail every year, although I haven’t gotten one in a long time because now it’s on the internet. Mine always went straight into the trash bin anyway. Why? Because the package insert isn’t really used by anyone in using any drug. We use published scientific data and expert opinion in deciding how and when to use a drug. The PDR site has a pretty interesting disclaimer in fine print at the bottom: is to be used only as a reference aid. It is not intended to be a substitute for the exercise of professional judgment. You should confirm the information on the site through independent sources and seek other professional guidance in all treatment and diagnosis decisions.

The package inserts are, in my opinion, mostly designed as an attempt to protect the manufacturers from liability for untoward outcomes. They throw in absolutely everything that seems remotely possible or has been anecdotally reported. And you should know the reporting system is not filtered at all, merely compiled. I’ve seen lists of side effects that include opposite things: constipation or diarrhea, high blood pressure or low blood pressure, and quite a few others. Vaccine package inserts are no different in this respect from those for a host of other drugs. Even the insert for normal saline, which is salt and water, sounds kind of scary. Saline is one of the cornerstone treatments we use in pediatric critical care, yet the insert warns: “Safety and effectiveness of Sodium Chloride Injection, USP 0.9% . . . in pediatric patients have not been established.” This is pure nonsense. We inject it as quickly as possible all the time for severe shock. I’ll end with this useful image, since vaccine skeptics do love to pepper their posts with dramatic images:


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