So if drug development is so expensive and most drug candidates fail before making it to patients, where does the cash to run this process come from? Our next chapter covers what you’re probably curious about: the money! But first, if you’d like to go a bit deeper into drug development, we recommend this truly fascinating [OPTIONAL] article: Operation Warp Speed: The Untold Story of the COVID-19 Vaccine, which appeared in Vanity Fair in November 2023. The first vaccines for COVID-19 were developed at record-breaking speed, and the article shares the incredible and intense story behind how that occurred. It also illuminates the complex interplay between politics, science, finance, manufacturing, and regulation that will always be at work in drug development.
Yes, we’ve just finished telling you about how long new drug development usually takes. But the COVID-19 vaccine approval process represents an exception to these norms — it essentially demonstrates the maximum fastest possible timeline. Several factors contributed to this success: assembly of an incredible team of the very best people; massive public and government support; significant prevalence of the disease among all ages and ethnicities all over the world; emergency authorization of the first products by the FDA; and the fact that money was no object on our way to a solution.
As a counterexample, let’s look at a drug that took nearly forever to get approved.
Dimethyl fumarate (later marketed as Tecfidera) was proposed as a treatment for psoriasis in the ’50s by Walter Schweckendiek, but it wasn’t commercialized until 1994, Fumapharm AG got approval to sell it as a psoriasis treatment in Germany. In the ’00s, it was proposed that dimethyl fumarate could make an effective treatment against an additional indication: Multiple Sclerosis (MS). (Side-note, this is something called scientific spillover, which we’ll talk a bit more about in chapter 6.) Clinical trials to use dimethyl fumarate to treat MS started in 2004, and the rights were soon bought by US pharma company, Biogen. They were able to wrap up clinical trials by 2012 and gain FDA approval in 2013.
So depending how you count it, it took anywhere from 9 to 60ish years.
And then there are all the diseases that we’ve been trying to treat for as long as anyone can remember. But alas, there is still no cure to the common cold, no universal flu vaccine, and a plethora of diseases we can only treat with varying results and no real cure.