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This is relevant in light of the US senate recently passing a measure that removes the requirement for animal testing of pharmaceutical products prior to commen

This is relevant in light of the US senate recently passing a measure that removes the requirement for animal testing of pharmaceutical products prior to commencement of phase 1 studies. Note that the congress.gov link is outdated: the bill unanimously passed in the senate on Sep 29. https://www.congress.gov/bill/117th-congress/senate-bill/2952/text?q=%7B%22search%22%3A%5B%22FDA+Modernization+Act%22%2C%22FDA%22%2C%22Modernization%22%2C%22Act%22%5D%7D&r=1&s=1 https://www.congress.gov/bill/117th-congress/senate-bill/295...

gus_massa 4y ago
Juts assuming that Big Pharma is greedy, isn't it cheaper to kill a few mice instead of a few humans in a phase 1 study? In which cases they can skip the animal tests?
refurb 4y ago
The bill doesn't prevent the use of animal studies, it just allows other studies to be used to prove pre-clinical safety. The requirement to prove a basic level of safety before doing human trials doesn't change. “(1) Cell-based assays. “(2) Organ chips and microphysiological systems. “(3) Computer models. “(4) Other non-animal or human biology-based test methods. “(5) Animal tests.”.
lend000 4y ago
This post on the eve of the animal testing requirement is honestly even less compelling than the argument "what about the bad guys" when politicians talk about outlawing encryption. The US FDA, as it exists today, is the single biggest hurdle to global medical progress (because other developed countries with socialized medicine are still getting about half their new drugs from the US). It costs a billion+ dollars (in FDA testing alone) and many years to push a single drug into the market. Even during an unprecedented pandemic where things are being rushed and all the world's pharmaceutical resources are poured into the drug development, it still took a solid year after vaccines were developed. 90 years ago, animal testing was often the best option. But in this specific example, the drug manufacturer didn't do any kind of testing at all, so it isn't much of a fair comparison. And as a sibling commenter mentioned, there are other effective tests that can be done before human trials, saving time and animals.

gus_massa 4y ago

Juts assuming that Big Pharma is greedy, isn't it cheaper to kill a few mice instead of a few humans in a phase 1 study? In which cases they can skip the animal tests?

refurb 4y ago

The bill doesn't prevent the use of animal studies, it just allows other studies to be used to prove pre-clinical safety. The requirement to prove a basic level of safety before doing human trials doesn't change. “(1) Cell-based assays. “(2) Organ chips and microphysiological systems. “(3) Computer models. “(4) Other non-animal or human biology-based test methods. “(5) Animal tests.”.

lend000 4y ago

This post on the eve of the animal testing requirement is honestly even less compelling than the argument "what about the bad guys" when politicians talk about outlawing encryption. The US FDA, as it exists today, is the single biggest hurdle to global medical progress (because other developed countries with socialized medicine are still getting about half their new drugs from the US). It costs a billion+ dollars (in FDA testing alone) and many years to push a single drug into the market. Even during an unprecedented pandemic where things are being rushed and all the world's pharmaceutical resources are poured into the drug development, it still took a solid year after vaccines were developed. 90 years ago, animal testing was often the best option. But in this specific example, the drug manufacturer didn't do any kind of testing at all, so it isn't much of a fair comparison. And as a sibling commenter mentioned, there are other effective tests that can be done before human trials, saving time and animals.