Drug development – explaining a complicated process, including vaccines

Based on some of the comments I see on the internet, I think that that people believe that drug development is easy. Anyone can do it. And all you have to do is invent a drug and, voila, it’s approved and you can make billions of dollars in gold

I might be over-exaggerating, but I’ve always thought that the anti-vaccine crowd believes in their heart that the development of vaccines includes throwing a bunch of stuff in a blender along with dollops of mercury, formaldehyde, aborted babies, and aluminum, which is poured into a vial and sold for billions of dollars. Despite those anti-vaccine myths, pharmaceutical drug development (including vaccines) is a difficult process that fails 99% of the time.

Drug and vaccine development is the total opposite of easy. It takes time, a lot of brilliant minds, and some luck. Sure, some worthless drugs do get approved (we’re eyeballing you Biogen), but almost every drug that fails to have a significant benefit to cost (in terms of safety and price) ratio will fail to get FDA approval.

The myths about drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias, you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).

One of the largest myths is 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 the process of drug and vaccine development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths from the facts of pharmaceutical drug development.

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