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by notch656a 1627 days ago
I'm not arguing with what you're saying, but GC/MS can be bought for like $100 a sample and it's conceivable a system can be invented where private auditors audit the output of an unregulated pharmaceutical manufacturer in such a way that the QC assurances to the consumer are as good or better as in our current system, with much lower regulatory costs.
2 comments

In the limit what you are describing is a generic drugmaker.

It's certainly possible to audit drug quality by sending it to labs, and people do that for darknet drugs all the time, but there are still problems:

1) There is no way to use ex-post analysis alone to achieve the kind of QA that pharmaceutical companies do; they have visibility into the entire manufacturing process and process control. Put another way, a sample of a drug cannot be used to verify that the process used to manufacture it is safe.

2) There is no assurance that anything you get in the future is made with the same process.

The only way I see this working, honestly, is for a rogue jurisdiction to offer safe harbor to "generic pirates". The rogue jurisdiction would offer legitimate regulatory oversight in exchange for tax revenue, and the drugs would be smuggled out of the jurisdiction for sale. To some extent this is already the case in grey markets where brand name drugs which are sold for less in other countries get arbitraged/smuggled back to high-cost markets.

Here's a possible approach.

Buy n = 1024 doses of your insulin or whatever, D(0, i) for i from 0 to n - 1 = 1023, homogenize each dose, and divide each one in half into half-doses called E(0, i) and F(0, i).

Mix pairs F(0, 2*i) and F(0, 2*i + 1) into 512 new doses D(1, i) for i from 0 to 511. Homogenize these new doses and divide each one in half into half-doses called E(1, i) and F(1, i).

Mix pairs F(1, 2*i) and F(1, 2*i + 1) into 256 new doses D(2, i) for i from 0 to 255.

And so on, until in step k = lg n = 10 step you mix the half-doses F(k - 1 = 9, 0) and F(9, 1) into a single dose D(k = 10, 0). Send this D(k, 0) off to the lab to be analyzed.

If the lab is equipped to detect dangerous impurities in your insulin at one-thousandth the danger level, which is reasonable for many contaminants, and the sample comes back clean, then you know that all 1024 doses were safe, though some of them may have the wrong dose. Mix the remaining 1023 doses well so that they all have the same dose and store them safely.

If not, you need to track down the contamination (or massive dilution), so in the next iteration, you send E(9, 0) and E(9, 1) to the lab for analysis. If one of them comes back safe, you know the 511 doses that were mixed into it were okay, and you can mix them well and store them safely, then repeat the process on the contaminated subtree.

Depending on your cost function (latency, shipping and handling costs, etc.) and your priors for correlation among the samples, it might be worthwhile to recurse more deeply on failure: instead of sending E(9, i) for i from 0 to 1 to the lab, you might instead send them E(6, i) for i from 0 to 15. If one out of 30 doses was randomly contaminated, for example, about 14 out of the 16 groups will be bad on average, while if it's one out of 100, then you'll have about 7 bad groups out of 16. At some point you need to give up on the recursion, too, or you'll end up testing almost all 1024 doses when they're all bad.

This of course doesn't solve the problem of future buys, just reduces it by the factor of n.

I think we are seeing the same thing, a system designed to remove corruption/regulatory capture/lobbying as far as possible from the process. I'm seeing a "rogue" auditor that performs the same service, while you are seeing a rogue government. If the outcome is the same, I am fine with either. Your pointed weakness regarding auditing the manufacturing process could be incorporated into either.
> I think we are seeing the same thing, a system designed to remove corruption/regulatory capture/lobbying as far as possible from the process

Not really. It's more like a system to selectively remove intellectual property rights without destroying the financial incentive to develop drugs.

Oh. So you don't want a system that removes corruption, regulatory capture, and lobbying as far as possible? I don't want to destroy the financial incentive either, I think it's great people that bring wanted goods to market profit from it.

IP is an interesting point, although I'm not convinced that generating the IP is more than a small fraction of the cost of a drug. An aggregate I saw from 2011-2018 puts Research at only 17% of revenue, and only some proportion of that is geared towards generating IP. That is to say, with all else removed you could generate an IP only company for 17% the cost of drug sales.

> Oh. So you don't want a system that removes corruption, regulatory capture, and lobbying as far as possible?

Well, sure. But that's not what this is actually about. The titular anarchists are not inventing new drugs, they're finding alternative ways to get drugs that have already been invented.

> That is to say, with all else removed you could generate an IP only company for 17% the cost of drug sales.

I am not convinced that accurately reflects the reality of running a pharmaceutical business, even if incentives/competition is somewhat warped in healthcare. There are a lot of penny-stock pharma companies whose only mission is to generate valuable IP. They're notorious for being volatile (since their outcome is basically binary on the results of research), but not for being great investments. If what you are asserting was actually true, those sorts of firms would generate ~5x higher returns, on average.

>Well, sure. But that's not what this is actually about. The titular anarchists are not inventing new drugs, they're finding alternative ways to get drugs that have already been invented.

... yes and they're doing so because in part regulatory capture, lobbying, and corruption have lead to unaffordable drugs. So that is, partially, what this is actually about. But sure there are other reasons for people to manufacture their own drugs outside of formal channels.

>I am not convinced that accurately reflects the reality of running a pharmaceutical business, even if incentives/competition is somewhat warped in healthcare. There are a lot of penny-stock pharma companies whose only mission is to generate valuable IP. They're notorious for being volatile (since their outcome is basically binary on the results of research), but not for being great investments. If what you are asserting was actually true, those sorts of firms would generate ~5x higher returns, on average.

That's actually my point. Generating the IP looks to be low value compared to wading through all the insane regulatory barriers, developing sales channels in-bred with medical board licensed doctors and FDA regulators that examine sales materials, lobbying for regulatory capture and all the other expensive pursuits that arguably may not add much value to the ill person consuming the drug. Another words, I'm not sure removing IP from the equation really changes the cost of drugs that much.

>it's conceivable a system can be invented where private auditors audit the output of an unregulated pharmaceutical manufacturer in such a way that the QC assurances to the consumer are as good or better as in our current system, with much lower regulatory costs.

No, it's not. This is ideological libertarian nonsense. There's a reason pharma came to be regulated in the first place. All this will lead to are more injuries and death of consumers.

>No, it's not. This is ideological libertarian nonsense.

If I could flag your post, I would. This is purely political nonsense and a god-like attempt to disprove something through fiat.