A lot of important medicines entered clinical use within a couple of years of their initial discovery:
- Anti-sera for diphtheria, developed 1890, implemented 1892 [1]
- Salvarsan for syphilis, discovered 1909, introduced 1910 [2]
- Blood types discovered 1900, first successful transfusions 1907 [3]
- Insulin discovered 1921, diabetics treated 1922 [4]
- HIV confirmed to be the cause of AIDS 1984, AZT approved by the FDA 1987 [5]
All of these rapid introductions addressed widespread deadly illnesses that had no existing treatment.
But once there is an effective treatment for a condition, drug developers face what’s known as the “better than the Beatles* problem”.[6]
Imagine that you are starting a rock band and are trying to get gigs and sell records (back when those were a thing). But no one is buying – they tell you “We’ve listened to you and we’ve listened to the Beatles. They are better, therefore we are going to keep listening to them and buying their records. Go away and keep rehearsing and write better songs.” How long might it take before you were successful?
Every new drug that is approved sets the bar higher for the next approval. Unless it is more effective or has fewer side effects, it is not likely to be approved or to succeed in the marketplace. Drug discovery, by its nature, gets harder and harder over time.
Most new drugs that are approved are just incremental improvements over existing treatments. It takes a lot more evidence – and thus time – to convincingly demonstrate small differences.
Long lead times to approval are a sign that medicine in general and drug-making in particular are mature sciences. Real breakthroughs become progressively rarer.
The good news about this is that there are now few major medical conditions (like Alzheimer’s) that are completely untreatable. The bad news is that progress in lengthening our lifespans is going to keep slowing down. Don’t count on living to 200.
*I would substitute the Stones/Dylan/the Dead here, but this isn’t my analogy. Of course, when I was ten years old I was pretty certain the Monkees were better. They had their own TV show, QED.
Footnotes
[1] Remembering Emil von Behring: from Tetanus Treatment to Antibody Cooperation with Phagocytes
[2] Top Pharmaceuticals: Salvarsan
[3] Highlights of Transfusion Medicine History
[4] The Discovery Of Insulin – How Was Insulin Discovered?