Argument by Vaccine Package Inserts – they’re not infallible

vaccine package inserts

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.

The snarky Orac has 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, at least for vaccine discussions.

Before we start, vaccine package inserts are important documents, but only if the information included therein is properly understood. However, vaccine package inserts are not documents that serve as medical and scientific gospel. But it is a document that can help clinicians use vaccines (or frankly, any medication) properly. Continue reading “Argument by Vaccine Package Inserts – they’re not infallible”

Big Pharma and development of drugs – debunking myths

As I’ve written more times than I can imagine, in the hierarchy of scientific evidence, the best primary evidence for the usefulness of any therapeutic method (including medications) are clinical trials, with double-blind, randomized ones considered the gold standard.

Despite the fact that clinical trials form the foundation of all medical evidence, I sometimes get the impression that many people think it is easy. And that any claims for a new drug or medical device flies through this process, with Big Pharma’s desires taking precedence over science.

Big Pharma and development of drugs are a bone of contention, even to those who don’t jump on board the various conspiracies about the pharmaceutical industry. There is a myth that there really isn’t any regulation – Big Pharma owns the FDA (and other regulatory agencies), and does whatever it wants.

But let’s look at it carefully, including how most drugs are developed and brought to the market. Let’s try to separate the myths of Big Pharma and development of drugs from the facts.

Continue reading “Big Pharma and development of drugs – debunking myths”