Last week the FDA approved esketamine for treatment-resistant depression.
Let’s review how the pharmaceutical industry works: a company discovers and patents a potentially exciting new drug. They spend tens of millions of dollars proving safety and efficacy to the FDA. The FDA rewards them with a 10ish year monopoly on the drug, during which they can charge whatever ridiculous price they want. This isn’t a great system, but at least we get new medicines sometimes.
Occasionally people discover that an existing chemical treats an illness, without the chemical having been discovered and patented by a pharmaceutical company. In this case, whoever spends tens of millions of dollars proving it works to the FDA may not get a monopoly on the drug and the right to sell it for ridiculous prices. So nobody spends tens of millions of dollars proving it works to the FDA, and so it risks never getting approved.
The usual solution is for some pharma company to make some tiny irrelevant change to the existing chemical, and patent this new chemical as an “exciting discovery” they just made. Everyone goes along with the ruse, the company spends tens of millions of dollars pushing it through FDA trials, it gets approved, and they charge ridiculous prices for ten years. I wouldn’t quite call this “the system works”, but again, at least we get new medicines.
Twenty years ago, people noticed that ketamine treated depression. Alas, ketamine already existed – it’s an anaesthetic and a popular recreational drug – so pharma companies couldn’t patent it and fund FDA trials, so it couldn’t get approved by the FDA for depression. A few renegade doctors started setting up ketamine clinics, where they used the existing approval of ketamine for anaesthesia as an excuse to give it to depressed people. But because this indication was not FDA-approved, insurance companies didn’t have to cover it. This created a really embarrassing situation for the medical system: everyone secretly knows ketamine is one of the most effective antidepressants, but officially it’s not an antidepressant at all, and mainstream providers won’t give it to you.
The pharmaceutical industry has lobbyists in Heaven. Does this surprise you? Of course they do. A Power bribed here, a Principality flattered there, and eventually their petitions reach the ears of God Himself. This is the only possible explanation for stereochemistry, a quirk of nature where many organic chemicals come in “left-handed” and “right-handed” versions. The details don’t matter, beyond that if you have a chemical that you can’t patent, you can take the left-handed (or right-handed) version, and legally pretend that now it is a different chemical which you can patent. And so we got “esketamine”.
