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Comment by BurningFrog | Hacker News Reader

After Phase 2, the drug has been proven safe.

In a sane and humane system, sick people would then be allowed to try it.

I just gave you a document containing 8 case studies where drugs were found to be not safe after having passed Phase 2 trials.

That happens after Phase 3 trials too.

This is about probabilities, and when lives are at stake, you should take some chances.

I would agree that drugs which have passed Phase 2 trials should made available to "mercy" patients during Phase 3 trials for patients that were not able to get into the trial...at cost to the pharmaceutical company that hopes to sell the drug/

This would eliminate the profit motive that other commentators have noted would be a huge issue.

Especially if you're basically dead without it, and you've tried everything else.

The alternative is worse, unfortunately. See the recent Aduhelm debacle for example, with big pharma profiting from desperate people, with a drug that doesn't work.

Pharma would market a phase 2 trial drug as a “potential revolution in treatment. Only a select few can receive this treatment and as a result it costs 10x more than existing drugs. Ps. We don’t guarantee results.”

Is that really the outcome you want?

What I want is fewer people to die while waiting for the FDA to take years to approve already existing drugs.

You seem to care more about marketing than people's lives. We all have different priorities.

(Not the OP) In a macro sense, I'd agree with you; no stranger to having to weigh the risks/rewards of experimental drugs.

But at the same time, I do get why extensive approval is needed - deaths can and often do occur from allergic reactions and/or side effects to medicines, and the idea is to hopefully lower the ratio of that happening. At some point more people "will" die from allergic reactions/side effects than the time it takes to get approval.

What people usually miss is the cost in lives of delays in approving or developing cures:

https://marginalrevolution.com/marginalrevolution/2021/01/th...

Fewer people dying and more people overpaying for ineffective treatment is potentially a good tradeoff. As a society we already funnel massive amounts of cash to new medical treatments, we just do it in a really inefficient way.

Except vioxx. One of the biggest mistaken approvals of all time.

https://en.wikipedia.org/wiki/Rofecoxib#Withdrawal

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