> How do you educate and provide information about the drug without an understanding whether it works or is safe?

How do you do it for the people in a clinical trial? Somebody has to be the first.

> Medical science has produced untold numbers of what would be classified as miracles 70 years ago. I can name a half dozen people I’m personally acquainted with who live today because of effective, safe treatments.

The argument is not that no progress is made using more conservative methods, it's that there is a level of "safety" where the additional progress not made would have saved more lives than would be lost to somewhat less conservative methods.

> As the disgusting affair around COVID has demonstrated, hucksters and idiots will happily push unsafe, ineffective treatments for a variety of self-serving reasons.

Meanwhile the bureaucratic red tape around initial testing allowed the virus to spread as far as it did in the early days, dramatically increasing the scope of the problem and costing many lives.

Clinical trials have informed consent and medical monitoring.

I don’t understand how someone could argue that establishing that a drug works and will not harm you is “red tape”. I won’t comment on COVID testing because the facts are not established and the depths of incompetence and criminality associated with the topic are yet to be discovered.

> Clinical trials have informed consent and medical monitoring.

How is "informed consent" (to the extent that that is even possible) not possible outside the context of clinical trials?

And "medical monitoring" doesn't mean it won't kill you, it only means if you die they write it down.

> I don’t understand how someone could argue that establishing that a drug works and will not harm you is “red tape”.

It prevents you from using a drug that could work based on no evidence that it doesn't. That is a much more aggressively authoritarian stance than prohibiting something which is actually known to not work or be harmful.

It also prevents you from using things that are known to work, and are used in other countries, but have no one to pay for the US clinical trials because no one holds a patent on it, e.g. because it's a part of a plant.

Like i said, there are a host of ethical issues.

We live in a world where Alex Jones exists and people will use religion and hocus pocus vitamins/supplements to peddle fake medicine.

Those charlatans live in a regulatory loophole that allows dietary supplements to be marketed in fraudulent ways. So it’s pretty obvious to figure out what would go wrong with medicine if you care to look.

Most of the issues you are worried about are more about the business model of medicine.

> And "medical monitoring" doesn't mean it won't kill you, it only means if you die they write it down.

I think perhaps you've never run a clinical trial. What's involved is far beyond what you are describing.

You are taking an untested experimental drug. It could kill you, or cause paralysis or brain damage or sterility or cancer or organ failure and require you to get a transplant and spend the rest of your life on immunosuppressants.

Monitoring can't save you when the damage is already done by the time the evidence of damage is discovered.

Let me flip it around the other way: because many people were not casually poisoned due to laws about drug safety, aerosolized lead and lead paint chips, food safety, seat belts etc there are more people around today to develop new things. This is the Julian Simon argument — and he was a famous libertarian!

> Meanwhile the bureaucratic red tape around initial testing allowed the virus to spread

I see this lazy argument all the time. A test that has not been characterized and qualified produces unknown results (what percentage are false positive? False negative? Does that improve if you tweak the protocol?). If your test produces unknown results they are simply noise, and increasing the rate at which you produce noise cannot improve your judgement.

> Let me flip it around the other way: because many people were not casually poisoned due to laws about drug safety, aerosolized lead and lead paint chips, food safety, seat belts etc there are more people around today to develop new things.

That doesn't flip it around at all, it's still the same problem. There is a trade off between costing lives by being too reckless and costing lives by being too conservative. Your argument in fact exacerbates the problem of being too conservative -- of being too far away from the optimal trade off in either direction -- because it applies just as much to the lives lost to slower progress.

And banning lead or similar is a completely different situation because the data is in on lead. It's not prohibited because we don't know if it's bad for you or not, it's prohibited because we do know that it's very bad for you with a high degree of confidence. It's obvious what to do with things that are well known, the question is what to do with things that are not.

> A test that has not been characterized and qualified produces unknown results

Known and unknown are not binary states. You can have a new test which is more likely to work than not based on all currently available evidence and you have to choose whether to use it during the period when better data is being gathered. The best answer is not automatically no.

That is different than the problem for approvals in general, but still the same. In the normal case you have to choose whether less rigorous use is allowed in early stages which provides more data prior to making the decision of whether to even do the more expensive more rigorous trials, thereby making the rigorous trials that are actually performed more likely to have positive results and increasing the number of effective treatments on the market.

Are you arguing the FDA was not involved in the U.S.'s delayed testing roll out?

Because everyone else I've read in the medical industry made the argument they (and the CDC) were a large cause of why our testing was behind other countries. (this includes a previous director of the FDA)