Drug Development is Hard, A Continuing Series: Part I

There is an old joke in the drug development business that if aspirin were created today you couldn’t bring it to market. Why? Because it has a largely unknown mechanism of action—it works, but we’re not genuinely sure how it works—and that would make it hard for regulators to let you sell aspirin. 

We are running into something similar right now with drug development for various, ahem, ongoing concerns, with one particular antimalarial drug of highly uncertain mechanism of action, chloroquine, possibly having some efficacy. The entertaining part is how speculative the explanations are, with no one quite certain how it would work, if it works, assuming it works, which we’re really not sure about.

Consider how messy chloroquine is in just one non-malarial indication:

  • Displayed beneficial effects in vitro
  • Exacerbated infection in animal models
  • Lacked therapeutic effects in a clinical study
  • Caused joint pain among human volunteers

So much of drug development is just one big 🤷‍♂️.