The political uncertainties of western countries where "there is no truth" and "facts don't matter" could easily bring this level of systemic corruption to them as well. People love to rage bait and say how bad it is now, but that seems to have largely led to groups giving up on enforcing norms, and bodes poorly for the future.
Not after the opioid crisis in the US. That was the job of the FDA to prevent that exact scenario. They approved Purdue Pharma opioids for non-chronic usage when European/Canadian regulators did not. Hence why the crisis was largely contained to the United States.
Leo Szilard (he's credited with theorising purposeful fission and patenting core ideas long before the Manhattan project got off the ground) wrote a long time ago about a (dys/u)topia where technocrats made the decisions. He had this idea "the bund" would fix politics by moving decision making to pure evidence based rational methods.
It wouldn't work, but when I see appeals to authority (FDA) enter the room, it's usually to feel superior because its a logical fallacy in argument but the place it actually fits (which btw, is here, in this thread) is that compliance to standards and policing them, is not "argument" it's the "you only had one job" part of the gig.
"yes Mr Kennedy, these friends of yours are very nice at parties, but unfortunately they are neither qualified, nor actually capable of fulfilling their role and so no, you won't be appointing them" is what the Bund would do.
Being able to take a compliance body oversight function and leverage it to remove adjuvents because of one paper, despite overwhelming evidence to the contrary, is precisely whats wrong in the current politicised situation.
If people making generic cancer drugs for use in africa had to be held to the standards in the west, we'd all be better off. I have said elsewhere that if the US rejects flu vaccines because of the mercury, they should be checked for other compliance and standards, and subject to cold chain integrity shipped to economies who usually can't afford them, and can use them.
>"yes Mr Kennedy, these friends of yours are very nice at parties, but unfortunately they are neither qualified, nor actually capable of fulfilling their role and so no, you won't be appointing them" is what the Bund would do.
The irony here being that the degree to which Kennedy and Johnson bungled 'nam was in large part a doing of the professionals with their academic attitudes about how foreign policy and war ought to be conducted. Obviously you don't get do-overs with history but it's very possible that Kennedy's preferred cabal of self serving frat bros would have concluded "the Vietnamese are screwed either way but we come out looking better not escalating, dominoes be damned".
>If people making generic cancer drugs for use in africa had to be held to the standards in the west, we'd all be better off.
How can you say that without an understanding of how much it would shrink the market in Africa?
$600 "perfect" insulin vs $50 "good enough" insulin. Metaphorically speaking.
There's a lot of money for the few in systematic corruption! This is something that has to be constantly fought against. R have embraced it entirely, but it's also prevalent on the D side especially in machine-politics cities. Which is why everyone's really so upset about the NY Mayor primary. People have gone on record in the papers about being annoyed that the bribes - sorry, donations - they prepaid to Cuomo are now invalid.
american right-libertarianism is a thought-terminating ideology. "government bad, only private sector good" presupposes that we can't collectively provide services to residents/citizens, even when that's proven very effective in other countries.
I'll never forget a coworker telling me that in a previous job hunting round he had interviewed with a pharmaceutical group that was tracking the manufacturing process for batches of drugs and comparing the little tolerance mistakes (heated a little too high or held at temp a little too long or not quite long enough) and finding a market where they can sell that batch.
You'd like to think that companies have factories with quality control laws and there are local people trying to ensure that all of their product are up to the local standards. What you don't expect is that they are binning them like Intel CPUs, where they just make a batch and hope for the best, take cream off the top until the priority orders are done and then everyone else gets whatever is left. You might get a slightly better product sometimes but not be so lucky the next time.
I have sent in drug samples for testing, in my case they were name brand.
Variance per dose is about plus/minus 15% across the board. You might get 9mg one day, and 11.5mg another for a drug with a nominal 10mg label. Injectables are typically better than oral tablets it seems but not by a lot.
Purity was pretty good though, it was mostly a dosing variance I saw.
Is this system not preferable over just trashing anything not perfectly made? Sure it would be nice if everyone can have perfectly manufactured medicine, but that's not reality. I would think something that's still likely good is still better than nothing.
The same thing happens in food processing. The low quality stuff gets sold under a different, cheaper brand, or reprocessed into another product.
I'm not going to cast stones at this practice because as always the alternative isn't some magical world where all produce is perfect, the real alternative is that it gets thrown in the trash and wasted, and everyone is worse off despite feeling better about themselves.
Over here in The Netherlands, the milk for all milk products comes out of the same cows and is processed in the same tanks. When you're paying 2x the price for brand name milk, you're getting seriously scammed.
> the real alternative is that it gets thrown in the trash and wasted
My view is a bit different nowadays, but this is very much an extreme bird's eye view from very high up, looking at only the smaller processes I have no disagreement. So, my point is more like an alternative co-existing higher level view, not a replacement of what you and others say. You will still be right to want to optimize your processes of course.
I view it as different streams. Everything is a circle. There is a significant cost - energy (and time and space and effort). As long as we use ancient sun-energy dug out of the ground it's bad, but if we could power the circles with current sun energy it would not matter much.
You have one overall stream or flow, all materials, and output streams are various sizes of end products. The good stuff stream flows to the customers (and forms bigger circles), the mistakes are instead rerouted into the recycling stream.
In chemical engineering and in manufacturing you have the same. Making food, whether completely natural, or including any kind of processing even if it's just separation and packaging, will have similar properties. Quality varies, and you have additional processing streams for various qualities.
Sure, one would want to optimize the streams, but if we did not have the fossil energy source limitation, and maybe also space, if you have to go back to the growing fields, it would not matter too much.
----
Imaginary picture:
Imagine in the far future somebody set up a fully automated closed system for making food, from growing to putting it in a huge cafeteria buffet, fully stocked all day. But there is no more people. As long as there is energy, food is created, processed, put on the buffet, and then recycled, since there is nobody to actually eat anything.
Is it a waste? Well, yes and no.
The whole of earth is like that!
As long as there is energy the cycles continue. What is "waste"? If you take the very big view, everything just "is".
But again, our actual limitation is the energy source for our food cycles. Using ancient stored sun energy releases the carbon stored underground, and it also slowly depletes those stores. The real problem first of all is where we get the energy for our cycles from, not really if parts of it don't make it to the end customers. Opportunity cost, what we could use the space and general effort for instead of on recycling cycles comes a distant second, I think.
> the real alternative is that it gets thrown in the trash and wasted, and everyone is worse off despite feeling better about themselves
Depending on what's the minimum quality you consider acceptable for the product, you might want to throw away something and have good reasons to feel good about yourself doing it. There is a point where something dips below good ("less effective medication") and even neutral ("it's an empty pill"), into actively harmful ("it will kill you faster"). Discarding it instead of monetizing it is the positive outcome.
If the product is ineffective you’re stealing from people. And in the case of pharma, probably ruining their lives in the process, since we rarely do more than two care plans at once and if one is busted then they should be doing something else instead.
If you've taken a prescription over a long enough time you'll know this to be true even if you've never really considered it.
Some time ago I was very frustrated with the massive swings in how well a prescription was working so I started looking into it. Saved a pill from every month, sent 12 of them off for testing.
+/- 30% accuracy on that dosage, and that's within spec for the US. Some months your 20mg pills are 26mg. Others? 14mg. Later repeated this test with a family member's blood pressure medication, which has a dosage of just 0.5mg. Same deal, 0.35-0.65
Africa and China are awash with fake meds - perhaps even in India. Large amounts of fake drugs are common in Africa/China = deaths are common. Pharmacies are very aware of this and watch their sources. The big problem is very good copies of the container, box and printed insert that mimic exactly the true drugs are everywhere. A copied box/insert/vial/tablet that costs $1 can hold drugs worth $200 or more. There are gangs that buy them from China and try to insert them in the supply chain.
I was with Sanofi-Pasteur(before I retired) and we had strict QC controls on every batch(every single ingredient). Every ingredient was sampled and tested locally and a sample sent to various head offices in USA/Canada/UK/etc. Batch ingredients were kept in locked areas and only allowed out in a weighed batch amount. The whole area was a clean and watched area with limited access badges on each person working there. You could only enter your zone and use your lunch/toilet area.
Some ingredients are active and can have high values. Some are inert fillers. 1 milligram of fentanyl is minuscule = it ends up in a 25 or 50 milligram pressed tablet for ease of patient/pharmacy handling. Even adding the inert is complex as the active and the inert must mix with no settling or gravity segregation. Often the active is mixed with an intermediate diluent and a fluid that will not dissolve either and mixed in wiped surface mixer to make a very uniform paste which was then dried and granulated and this was added to the final diluent and a 'binder'. The binder is a material that will glue the tablet together in a high speed press. Some tablets get an enteric coating that resists acid but dissolves in the lower gut alkaline state = breaks and dissolves.
Fentanyl and other strong opioids are killers in small amounts, so extreme precautions are taken to ensure correct doses.
You are going to rue the day. Enjoy your temporary comforts. You got so used to speaking of other people that are not in your demographic (especially Africans) as almost human that Africa will also not shed a tear should America be gone tomorrow And yes, we will survive your abscence, like we had since the beginning of time Tick tock (Or Tik Tok:-), more aptly)
27 comments
[ 2.6 ms ] story [ 40.8 ms ] threadIt wouldn't work, but when I see appeals to authority (FDA) enter the room, it's usually to feel superior because its a logical fallacy in argument but the place it actually fits (which btw, is here, in this thread) is that compliance to standards and policing them, is not "argument" it's the "you only had one job" part of the gig.
"yes Mr Kennedy, these friends of yours are very nice at parties, but unfortunately they are neither qualified, nor actually capable of fulfilling their role and so no, you won't be appointing them" is what the Bund would do.
Being able to take a compliance body oversight function and leverage it to remove adjuvents because of one paper, despite overwhelming evidence to the contrary, is precisely whats wrong in the current politicised situation.
If people making generic cancer drugs for use in africa had to be held to the standards in the west, we'd all be better off. I have said elsewhere that if the US rejects flu vaccines because of the mercury, they should be checked for other compliance and standards, and subject to cold chain integrity shipped to economies who usually can't afford them, and can use them.
The irony here being that the degree to which Kennedy and Johnson bungled 'nam was in large part a doing of the professionals with their academic attitudes about how foreign policy and war ought to be conducted. Obviously you don't get do-overs with history but it's very possible that Kennedy's preferred cabal of self serving frat bros would have concluded "the Vietnamese are screwed either way but we come out looking better not escalating, dominoes be damned".
>If people making generic cancer drugs for use in africa had to be held to the standards in the west, we'd all be better off.
How can you say that without an understanding of how much it would shrink the market in Africa?
$600 "perfect" insulin vs $50 "good enough" insulin. Metaphorically speaking.
You'd like to think that companies have factories with quality control laws and there are local people trying to ensure that all of their product are up to the local standards. What you don't expect is that they are binning them like Intel CPUs, where they just make a batch and hope for the best, take cream off the top until the priority orders are done and then everyone else gets whatever is left. You might get a slightly better product sometimes but not be so lucky the next time.
In the UK I know the NHS buys generics, which implies they are effective, but I wonder.
Variance per dose is about plus/minus 15% across the board. You might get 9mg one day, and 11.5mg another for a drug with a nominal 10mg label. Injectables are typically better than oral tablets it seems but not by a lot.
Purity was pretty good though, it was mostly a dosing variance I saw.
I'm not going to cast stones at this practice because as always the alternative isn't some magical world where all produce is perfect, the real alternative is that it gets thrown in the trash and wasted, and everyone is worse off despite feeling better about themselves.
Over here in The Netherlands, the milk for all milk products comes out of the same cows and is processed in the same tanks. When you're paying 2x the price for brand name milk, you're getting seriously scammed.
My view is a bit different nowadays, but this is very much an extreme bird's eye view from very high up, looking at only the smaller processes I have no disagreement. So, my point is more like an alternative co-existing higher level view, not a replacement of what you and others say. You will still be right to want to optimize your processes of course.
I view it as different streams. Everything is a circle. There is a significant cost - energy (and time and space and effort). As long as we use ancient sun-energy dug out of the ground it's bad, but if we could power the circles with current sun energy it would not matter much.
You have one overall stream or flow, all materials, and output streams are various sizes of end products. The good stuff stream flows to the customers (and forms bigger circles), the mistakes are instead rerouted into the recycling stream.
In chemical engineering and in manufacturing you have the same. Making food, whether completely natural, or including any kind of processing even if it's just separation and packaging, will have similar properties. Quality varies, and you have additional processing streams for various qualities.
Sure, one would want to optimize the streams, but if we did not have the fossil energy source limitation, and maybe also space, if you have to go back to the growing fields, it would not matter too much.
----
Imaginary picture:
Imagine in the far future somebody set up a fully automated closed system for making food, from growing to putting it in a huge cafeteria buffet, fully stocked all day. But there is no more people. As long as there is energy, food is created, processed, put on the buffet, and then recycled, since there is nobody to actually eat anything.
Is it a waste? Well, yes and no.
The whole of earth is like that!
As long as there is energy the cycles continue. What is "waste"? If you take the very big view, everything just "is".
But again, our actual limitation is the energy source for our food cycles. Using ancient stored sun energy releases the carbon stored underground, and it also slowly depletes those stores. The real problem first of all is where we get the energy for our cycles from, not really if parts of it don't make it to the end customers. Opportunity cost, what we could use the space and general effort for instead of on recycling cycles comes a distant second, I think.
Depending on what's the minimum quality you consider acceptable for the product, you might want to throw away something and have good reasons to feel good about yourself doing it. There is a point where something dips below good ("less effective medication") and even neutral ("it's an empty pill"), into actively harmful ("it will kill you faster"). Discarding it instead of monetizing it is the positive outcome.
Some time ago I was very frustrated with the massive swings in how well a prescription was working so I started looking into it. Saved a pill from every month, sent 12 of them off for testing.
+/- 30% accuracy on that dosage, and that's within spec for the US. Some months your 20mg pills are 26mg. Others? 14mg. Later repeated this test with a family member's blood pressure medication, which has a dosage of just 0.5mg. Same deal, 0.35-0.65
[1] https://www.bbc.com/news/articles/cwyew21yyjzo