When Jenner created (really discovered) the original SmallPox vaccine, he basically just inoculated people with Cowpox and Horsepox. That was over 180 years ago. There were no phases, clinical trials or testing standards back then. Real medicine and snake oil were difficult, if not impossible, to distinguish.
Before Jenner, there were groups inoculating people with actual Smallpox (typically in the nose, because it was quicker to recover from). The Chinese started doing that 500 years ago, and it was even used by troops in the American revolutionary war. Some of those people would die of course, but the ones who recovered would have an immunity.
A lot of people may have died from many of these early tests, but so many people were dying it didn't quite matter.
The reason there's so much red tape related to drug development is because people were so free with drug testing in the past. There was a time when the FDA did not exist. We had a situation where people could sell anything and call it a cure without testing. Word of mouth was all that was needed to sell a cure whether it work or not. It was up to each buyer to decide if it cured the problem. We had situations where the cure was worst than the illness.
We need testing. It's the only way we can have confidence in our medical system.
I agree testing is important and your historical perspective is illuminating. My question is: What happens if the FDA does a bad job? It has a monopoly. They have an incentive to deny everything. If they deny a new drug and people die, it's hard to blame them. If they approve a drug that's dangerous, they get egg on their face.
> A lot of people may have died from many of these early tests, but so many people were dying it didn't quite matter.
This is the old ethics question: There is a highjacked planebfull of passengers flying towards a football stadium. Should it be shut down?
Many contemporary societies lean towards not shooting as you can't compare deaths.
Regarding vaccines the current approach is to first try it out on animals and then do controlled clinical studies with healthy test subjects etc. Still some people do suffer from those for the greater good.
In the US, drug testing is governed by complex regulatory frameworks as well as risks from tort liability.
If the government is willing to suspend these[0] in order to fast track vaccine development, then why isn't this the default for all new drug development?
Before Jenner, there were groups inoculating people with actual Smallpox (typically in the nose, because it was quicker to recover from). The Chinese started doing that 500 years ago, and it was even used by troops in the American revolutionary war. Some of those people would die of course, but the ones who recovered would have an immunity.
A lot of people may have died from many of these early tests, but so many people were dying it didn't quite matter.