> 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.

> 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.

This is particularly difficult for drugs that affect the brain, like MDMA for PTSD in veterans. What do you use as the control group for that, when patients and clinicians can tell that who got the real thing and who did not. I call this the bridge problem. In order to do science, you have to have a control group, but if I built a bridge across a ravine, we don't have to have cars drive off a cliff and fall into the ravine in order to scientifically prove that the bridge works and exists. We engineered a bridge and put it there and obviously if there was no bridge cars would just fall into the ravine so we don't need to test that the bridge exists. We design the bridge, we rate it up to a certain capacity, we don't test it until it fails, we simply prohibit really heavy trucks from driving on smaller bridges that can't take their weight.

We can't do any of that for drugs that affect emotions and consciousness because we're barely in the stone age of our understanding of the brain and the technology we have to affect it.

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