[londons_explore]

Thats still 1366 people every day worldwide.

Think about that... If the committee whose job is approving this medicine get results in on Friday, but don't sit down to approve it till the following Monday, then 4098 people die unnecessarily.

[londons_explore]

It always surprises me how little effort we put into getting things from the lab to the people quicker.

As soon as we have compelling data some discovery (medical or otherwise) might help lots of people, it should be almost a manhattan project type effort to get it into the hands of everyone worldwide asap.

[seanmcdirmid]

They do fast track drugs if studies show overwhelming success, and it is no longer ethical to keep it from the control group.

[londons_explore]

Other areas of medecine do do things in a rush - like an ambulance breaking the speed limit to maybe save one guy. Yet we wouldn't allow breaking the speed limit when delivering a new treatment to save thousands of lives.

[pas]

What's really inefficient is that every trial needs to spend (hundreds of) millions on writing up the whole thing, IRBs and FDA (and additional authorities) paperwork, recruiting, data analysis, etc. while these could all be standardized. (There are companies that do this, but they are just expensive middlemen. There was a great substack (?) post detailing a lot of these, but now I can't find it.)

[frankchn]

There are reasons why drug approval can be slow and conservative: https://en.wikipedia.org/wiki/Thalidomide_scandal

[londons_explore]

Yet the harm from that (10,000) was in many ways tiny compared to the harm from not deploying treatments that turn out to be good.

For example 780,000 people died of polio between 1988 and today. Yet for all that time there has been a cheap, low risk, well tested, near 100% effective vaccine (many in fact). And polio is probably one of the better cases because governments and charities have been pushing it pretty hard.

[harimau777]

The polio vaccine has been approved by the FDA during all of that time. Therefore, I don't understand how the deaths during that time provide evidence that the FDA should approve drugs faster.

Edit: Also, polio eradication efforts where a Manhattan project style heroic effort.

[peteradio]

It's hard to "dn no harm" when you yeet drugs at people based on maybe being useful.

[lm28469]

That's not how capitalism works though

[haldujai]

Not sure if you're specifically referring to the drug in this article but osimertinib has been FDA approved for ~8 years and has been part of routine clinical practice for quite a while now.

The system is actually really fast at getting promising cancer therapies into the hands of patients, especially when there aren't good alternatives.

Even if something isn't yet approved and the patient is ineligible for a clinical trial, an intervention can be offered to patients under compassionate grounds/special access.

[panabee]

the FDA face an unenviable challenge: how to promote healthcare innovation without endangering patients?

regulations that are too loose may cause suffering and death while regulations that are too strict will delay or block prevent helpful treatments.

regulating healthcare is extremely difficult and largely a thankless job.

one solution is to approach national healthcare like national security and let people volunteer for treatments like volunteering for the army.

in short, overstate risks but let patients decide.

adopt cigarette-simple consent forms that state in bold words that an experimental treatment is likely to cause death or crippling side-effects like paralysis, blindness, stroke, Alzheimer's, or worse.

perhaps require multiple signatories from family members to guard against irrational behavior.

this protects the FDA while minimizing barriers to innovative therapies and treatments.

[londons_explore]

> in short, overstate risks but let patients decide.

Then you have to battle the people selling highly marked up snake oil as an 'experimental' treatment - when every expert could tell you this treatment is already well known to be ineffective.

[lelanthran]

> Then you have to battle the people selling highly marked up snake oil as an 'experimental' treatment - when every expert could tell you this treatment is already well known to be ineffective.

Isn't that easily solved by requiring all experimental drugs and procedures to be provided free of charge with the cost footed solely by the provider?

[panabee]

indeed. this is a thorny problem with no perfect solution.

on the one hand, you may throttle promising treatments and on the other hand, you may increase useless treatments.

publishing results is one way to mitigate snake oil, though this obviously doesn't eliminate the problem.

the general framework is to maximize transparency and freedom.

letting people volunteer for national healthcare like they can for the national army increases freedom, but we must also increase transparency to combat snake oil.

[dantheman]

Anyone should be allowed to take any medicine that they desire. The FDA can still approve treatments, the problem with the FDA is that forbid patients from access to treatment they desire.