Donald Kirsch is a drug hunter--a scientist who works for pharmaceutical companies working to develop new drugs. He's worked for several different companies over the course of his career, and has lived through finding new drugs, having the quest to develop a new drug end in failure, or in the development of something entirely different from what they were after. He's lived through employers not thinking a promising new potential drug was promising enough, and the frustrations of getting drugs through the regulatory approval process.
This started out as a book about why drugs are so expensive. It wound up being about the excitement, tedium, adventure, frustration of drug development. And, oh yes, why it makes the end products so expensive.
Initially, for all practical purposes, all drugs came from plants. This was true in the time of Otzi the Iceman, who was carrying a Neolithic remedy for whipworms when he died. It was true down to quite recent times. when new drugs were developed and old ones, such as aspirin, have been extracted into purer and more powerful forms.
Then came, in modern laboratories, the creation of whole new chemical entities, working to produce chemicals that would attack diseases. The development of drugs from animals is the most recent approach and the hardest to make work, but from it we have, for instance, insulin, enabling diabetics to live much longer, fuller, and more normal lives.
At every stage of this history, developing new drugs has required imagination and risk-taking. Pre-modern hunters after cures for what ailed them and the other members of their communities had no alternative but direct experimentation on themselves and those they knew. Even today, with modern methods, protocols, and precautions, eventually a new drug has to be tested in clinical trials to be sure it is safe and effective in humans, regardless of how well it performed in animal or other forms of pre-clinical testing.
And sometimes, as Kirsch describes in a rather personal experience, the drug hunters still wind up having to test their drugs on themselves, to get to the point where they can even make a convincing pitch to their bosses, who have to approve the funding for further development and testing.
The process of drug development is as much art as science, with intuition and imagination, not to mention risk-taking, playing at least as large a role as rational analysis.
It's a fascinating story, and Kirsch tells it well.
Recommended.
I bought this audiobook.
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