Hacker News new | ask | show | jobs
by sithadmin 2852 days ago
>Providing drugs for free might give companies more data to help develop (or potentially prove safety, efficacy)

It's a nice thought, but you generally can't have patients and doctors opting-in for unproven treatments and expect the resulting data to stand up to any sort of scrutiny. To glean useful data, one would require a really, really large-n study population and clear impacts from use of the drug that are so pronounced they drown out nearly all other confounding factors (e.g. studies on the health impact of cigarettes) -- and expecting an unproven, last-resort type drug to attract a study population this large is just unrealistic.
2 comments
candiodari 2852 days ago
It's not just that experiments won't work like that, it's the consequences of experimenting on live human beings ... that is where the real problem lies. These companies don't want the freedom to experiment, they already have that. The technical way to state what they want is permission to do stage 2 trials ... and not be responsible for patient outcomes. If their liver gets reabsorbed (which is one of the more common "oops"es for drug testing), they don't want to pay for 50 years of dialysis plus constant treatments. That's what they're asking for.
link
CryptoPunk 2852 days ago
>>It's a nice thought, but you generally can't have patients and doctors opting-in for unproven treatments and expect the resulting data to stand up to any sort of scrutiny.

It can give much earlier indications of drug efficacy, even if it doesn't provide the proof of Phase 3 compliant studies.

The history of cancer research shows how earlier human experimentation can lead to a much shorter time between a drug being discovered, and it being proven effective enough to become a part of the standard treatmemt protocol. This shorter time to incorporation of an effective drug in standard treatments means survival for hundreds of thousands of people that would have otherwise died.

That the motivations of the parties that would be affected by the loosening of the rules are not all altruistic or even ethical is worth taking into consideration, but it can't be the only priority when crafting regulatory strategy.

link