[unchocked]

> Making human clinical trials cheaper and quicker is probably one of the biggest opportunities for improving U.S. healthcare both during and beyond pandemics.

The failure to accelerate vaccine development through challenge testing is a black mark on our ethical and regulatory system. the Moderna vaccine mRNA was developed two days after COVID-19 was identified, yet it took over a year to get through human testing. All the while, willing volunteers stood by at https://www.1daysooner.org

[cbsmith]

Keep in mind that vaccines solve a systemic problem, and a bad vaccine can exacerbate a pandemic. Yes, vaccines can be made in a day or two, but it takes a long time to know if they are effective.

[bjt]

That's not addressing the parent's point about a challenge trial though. A challenge trial could greatly accelerate measuring that effectiveness.

[cbsmith]

Yes, but a challenge trial doesn't require institutional but in.

[cbsmith]

s/but in/buy in/

[mchusma]

It actually doesn't take long to have high confidence vaccines work. Roughly 30 days. Day 1- inject vaccine. Day 15 - infect virus. Day 30 - know it works.

Human challenge studies were a ethical no brainer.

Even other studies if we gradually increased the number of people allowed to take them would mitigate almost any real risk. So you let up to 1k people take it month 1, 10k month 2, 100k month 3, and so on. Basically no meaningful extra risk but faster results.

Vaccines have a very good safety record and efficacy record, this isn't like cancer which is much more speculative.

Banning vaccines is not the answer. Most US deaths were completely preventable.

[esyir]

I strongly agree with reducing red tape for biomedical testing, but this is a drastic oversimplification of the current scenario, and of vaccine efficacy.

[cbsmith]

What are the odds that in hindsight, someone in your combinator would be for reducing the red tape? ;-)

[nickthemagicman]

How about we quit treating people like children and make all drugs legal?

The FDA stamp will just be a stamp of quality to help guide people to a known quality product.

No enforcement of drug laws at the barrel of an authorities gun.

But if people want to do some experimental off brand use that their doctor recommends then they can.

If people do their own research and want to self prescribe they can.

Getting the monopoly out of health care would reduce health care costs as well.

[buu700]

I've thought the same thing and generally agree with it. Why shouldn't I be able to walk to CVS and pick up a bottle of heroin and various prescription drugs? I'm an adult; I shouldn't even owe anyone an explanation.

At the same time, I think we would need to concurrently ban drug advertisements as other countries have. To me, that seems like a better balance between treating individuals as adults with autonomy and minimizing harm on the macro scale.

[dalbasal]

IMO, it's a mistake to approach these kinds of questions from first principles perspective, at least exclusively. We have a history, and a lot of where we are is a response to past problems. That doesn't mean where we are is optimal, just that it's not simple.

Snake oil is a major problem, always has been. Drugs of abuse are a problem, like the oxi crisis. Antibiotic resistance. Etc. There are lots of reasons to have controls in place that don't have a first principles logic to them... just an empirical one.

[buu700]

Makes sense. There's definitely room for disagreement without either side being malicious. On one hand there are the problems we see in front of us today of a lot of people having their lives unfairly destroyed by the state and billions of dollars being arguably wasted; on the other hand, we have to consider the problems that led to our current situation, and ensure that any solution we implement today doesn't excessively regress in those areas.

I'm still pro-full-legalization for the moment, but wouldn't just sign a bill if presented to me today without first ensuring that my administration had a firm understanding of all the historical issues, and felt comfortable that the bill reasonably addressed them (or, if not, that the cure at least wasn't worse than the disease). I know there's a pop culture narrative that drug prohibition was primarily motivated by malicious suppression of anyone Nixon considered undesirables, but from what I understand the real history is much more complicated.

Perhaps simple decriminalization would be a better first step, if not ultimately a better long-term solution as well. And, oh hey, it looks like that may soon be on the table: https://news.ycombinator.com/item?id=27522843

[xyzzy123]

The reason you can't go to CVS and pick up heroin or crack is:

Inevitably, lots of people would become addicted and there would be many deaths.

Very critical news stories would run. People neglecting their children to use drugs. Testimonies of loved ones and shattered families.

Politicians would be inundated with calls to regulate these dangerous substances.

Politicians who refused to do anything would be mired in conspiracy theories, accusations of conflict of interest and profiting from suffering. They would be voted out and replaced.

Regulation ensues.

[wolverine876]

> lots of people would become addicted and there would be many deaths

This is the reason. It doesn't require cynically blaming politicians. It's not wrong for politicians to act to prevent death, and to be responsive to their constituents. Those are good things.

[nickthemagicman]

Your entire post is pure speculation and fear mongering

All drugs are decriminalized in Portugal, Uruguay, etc. with less addiction and better addiction outcomes than the U.S.

They treat addiction like a disease like diabetes instead of a crime.

https://www.npr.org/sections/parallels/2017/04/18/524380027/...

[buu700]

I didn't get the sense that GP was necessarily agreeing with those positions, more illustrating the high-level political hurdles (right or wrong) that legalization fundamentally faces.

It's similar in my mind to self-driving cars. The first post-large-scale-rollout deaths will likely cause a political backlash, even if statisticians and scientists are able to show that the proposed regulatory response would cause more harm than good.

I don't agree that the successful implementation of such a regulatory response is a foregone conclusion in either case, but we will need to be prepared to deal with the reality of some people dying due to self-driving software issues and/or consumption of non-FDA-approved substances.

[nickthemagicman]

"Inevitably, lots of people would become addicted and there would be many deaths."

Outright wrong, baseless, and fear-mongering.

[teclordphrack2]

The only reason I like this idea is that we know a certain political segment of society would of been killed off by dumb decisions in this area via hydroxychloroquine.

[nickthemagicman]

Didn't that turn out to work?

https://www.medrxiv.org/content/10.1101/2021.05.28.21258012v...

[teclordphrack2]

No, it did not.

Please explain how you think the link you provided backs your opinion. Give me your analysis of the data presented. Let me know you actually understand it.

This is one paper on one hospital and only looking at data after the fact.

Across the USA if you were hospitalized more than 10 days you had a much higher chance of survival. It did not depend on any medication given. That is a stat that runs across the board. This study only includes patients that were given a treatment AFTER 10 days of hospitalization. Most of those that were going to die did so before this study would show they would of been treated.

[nickthemagicman]

Here's a more clear paper for you about HCQ.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7534595/#:~:tex....

"HCQ was found to be consistently effective against COVID-19 when provided early in the outpatient setting. It was also found to be overall effective in inpatient studies. No unbiased study found worse outcomes with HCQ use. No mortality or serious safety adverse events were found."

Also the articles that claimed it DIDN'T work were retracted because the authors of the articles couldn't prove their data.

https://www.the-scientist.com/features/the-surgisphere-scand...

https://www.thelancet.com/journals/lancet/article/PIIS0140-6...

Don't let your politics override fact.

[selimthegrim]

Furthermore HCQ advocates would reject this study because they want it tested with zinc as a prophylaxis before things get bad enough to send you to hospital