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In the same way Uber disrupted licensed taxis - or the big internet firms disrupted ad supported media.

ie totally ignoring existing regulations, pretending they don't apply to you and just hoping you can push through.

In a lot of the 'problems' are the regulations ( which are double edged and tricky to get right ) - and pharma companies are just following the rules.

I think governments might be less lax in letting there be a new wildwest in drug development.

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llamaimperative 4 hours ago | parent | next [-]

Pointing the finger at regulation is misleading IMO. The regulations for bringing a drug to market are essentially quite simple: prove that it’s better than what currently exists.

What makes it difficult is the word “prove”

It turns out it’s obscenely hard to make a drug that’s good, and even harder to prove that it’s good.

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DrScientist 3 hours ago | parent [-]

> prove that it’s better than what currently exists.

So how do you do that ethically? How do you justify taking off something that you know works to some extent and try something completely new or worse placebo? ie don't you have to construct the trial in the context of existing treatments etc?

These are the kind of challenges that makes drug development slow - in the end you don't do one trial, but a series of trials, slowly building confidence and making the case.

Often that's what takes the time during the clinical phase.

Of course it would be much faster to go straight to a big trial that would show how well your treatment works in conditions optimal to it - however that kind of 'move-fast break-things' approach involves potentially breaking things which happen to be people.

Regulation just reflects the cautious 'first do no harm' philosophy.

Now let's be honest - big pharma will simultaneous complain about regulation and the cost of development, and at the same time know it creates barriers to entry - there is always some frustration about the slowest of regulatory authorities to adopt new methods - however you wouldn't want your regulatory to be gungho.

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rflrob an hour ago | parent | next [-]

> or worse placebo

Just to be clear, most drug trials for anything where we have an effective treatment are not “new drug vs placebo”, but instead “new drug vs standard of care”. Thus the goal being to prove it’s better than what already exists.

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datavirtue an hour ago | parent | prev [-]

Inmates. Go wild. For some reason this abhores the intellegencia while myriads of innocent rodents get tortured.

	▲	wat10000 31 minutes ago \| parent \| next [-]
		Sorry, are you having difficulty with the concept that human prisoners should have more rights than mice?
	▲	DrScientist an hour ago \| parent \| prev [-]
		Purdue Pharma, fentanyl and doctors abrogating responsibility for patient safety is an example of 'go wild'. On your second point - I'd agree that a lot of animal experiments are not that informative - but lets be clear 'clinical trials' are simply experiments on people. I'm not sure I'd want to give Musk, Zuckerberg or Bezos free reign to experiment on desperate people in the medical space. Depends on whether you treat people as just grist to your money making mill - or perhaps you think the ends justify the means?

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jorvi an hour ago | parent | prev | next [-]

Uber disrupted taxis because taxis were a sleazy experience, with dirty old cars, “broken” meters and rude drivers that tried to get you to pay extortionate prices if they knew you were in a pinch.

Stop trying to venerate the taxi industry, they’re horrible.

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adventured 2 hours ago | parent | prev [-]

There's no hoping you can push through. The US Government has complete top-down control over the sale of prescription drugs in the US, from clinicals to approval to distribution & sale.

The sole reason Uber pulled off what they did, is there's no national authority governing taxi style services for all states and cities, it's a state and local effort. So Uber counted on navigating around zillions of slow local governments long enough to get big, and it worked very well. You can't do that in prescription drugs, the feds have a big hammer and can (and will) use it anytime they like.