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.
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.
> 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.
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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 alternate also happens though.
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.
Happy to live in a country with very strong food control. Yes we have the alternative labels yet it must be at least as good as the original.
They only need to be as good as the minimum standard for the category they're sold in. If you have a "good" bin and a "bad" bin, and the good bin easily exceeds the minimum requirements while the bad bin just barely meets them, that's fine, too. Or the good bin can be sold as class I, while the bad bin needs to be labeled as class II. Of course those categories usually aren't about safety-relevant aspects of quality, but things like weight or shape or appearance.
I want more good regulations, and less bad regulations, so I am not necessarily against anything you said here.
A quality increase does not mean "perfection" and so "magical" turns into "more expensive".
Id like to live in that world.
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.
How do we assess that it's "still likely good" and "still better than nothing"? If they are defective it also means that they might make things worse.
Hopefully that's up to the laws of where the incorrectly processed stuff was allowed to be sold.
Hopefully those countries don't reduce standards due to lobbying.
A fair number of countries can't do the proper inspections required for this, either due to lack of resources or government corruption (or both). They could put a literal carbon copy of FDA standards into their regulations, but it's meaningless without enforcement.
I believe we have a long history of companies selling toxic or non working stuff to countries not able to test or make sure its safe themselves.
There's a difference between a few percent difference in efficacy which is understandably still marketed (the same kind of thing happens when you leave meds on the shelf a while) and meds that are no longer effective at all to a reasonable level or toxic.
Why should a person in Somalia suffer and die from cancer while a person in Ohio, lives, soley on the basis of where they live?
Why should they not get access to drugs because the drugs would fail some bogus test made up by an american senator?
More accurate to say they should get access to drugs that contain the actual molecules they are advertised to have across markets.
You shouldn't be able to sell what is basically sugar water in Somalia and call it cyclophosphamide. That's fraud if I do it as a private citizen.
In fact it's even fraud for me if I buy actual cyclophosphamide, and cut it with a bio compatible totally non reactive filler compound. How are these people getting away with it without the president and senators being on the take? When they'd run you or I down in less than a month for effectively the same act?
To be clear, I don't believe you or I should be able to do this. But I know what happens to private citizens who try to do things of this nature. So there is no question that this is a crime. The only question is why is it not prosecuted for larger corporations.
Who is going to pay for the replacement drug?
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Why shouldn't every single person on earth immediately be granted citizenship to America and allowed access to all forms of welfare given to citizens? It's unfair to them
Speaking as a non-American, the dysfunction of US healthcare was one of the reasons I decided against the USA when considering an international move.
Not the primary reason, but it was part of it.
America is weird in that the poorest get significantly more benefits than the merely lower-middle class. And the majority of Americans pay no federal tax after EITC and other refunds.
You can get SNAP (free food), Section 8 (free housing), Medicaid (healthcare, CHIP for kids is easier than adults, but still many people get it), and if you manage to raise smart kids despite poverty they will get college for free as well (most highly-selective universities are free for the poor, but extremely expensive for even the middle class).
I own a lot of rental property and I have a Section 8 tenant who has never worked, completely gamed the system with a subjective disability that renders her unable to ever hold a job (supposedly). A good tenant but is constantly trying to give away tons of food she buys because she always tries to spend the SNAP she gets every month. And she gets free heat, and electricity, and public transportation pass, and on and on.
through my eyes i see a similar implication to disproprortionate judicial punishment - aspects of a hegemonic system designed to suppress individual voices. for example, pirates in the UK being handed jail terms of greater duration than those given to individuals having killed other humans - people daring to go against the powerful have their lives taken away from them, whereas infighting within the working class is almost encouraged by miniscule sentencing.
or in this case, why bother putting any effort into life when doing nothing provides a greater reward? why attempt to make something of oneself at the risk of losing everything forever?
all in all, whether or not intentionally curated, these societal facets serve to foment an atmosphere of fear - individuals are forced to exist either in ignorance, or otherwise must live with the knowledge that minor infractions may end one's dreams, while concurrently one's dreams may be ended at any time for no reason but the whim of another.
such a dichotomy between ignorance and fear effectively suppresses societal change, which if it were to happen anyway, would be instantly detected by automated surveillance, and promptly quashed under fully legal pretences. but that's not even necessary. the populace is already addicted to living vicariously through screens (now from birth thanks to parents being forced to devote energy to work instead of their children).
yet the world keeps turning
the person in somalia likely has a different cost/effectiveness preference vs the american, which is expressed through the lack of regulation.
To elaborate on this, if the individual in Somalia didn't want to die from said cancer and preferred better regulation, they would readily move to Ohio.
I sincerely hope both of you are just trying to make a joke. I don't think a web forum like this one is the right place for it, though.
hope all you want i think understanding what this site reveals about the world view of investor/dev types is a kind of sociological? shock.
its like everyone learning during covid their neighbors would kill every service worker to avoid the inconvenience of making their own coffee. it leaves a mark.
see what happened to the poor n-gate.com fellow, burned him out
The person in somalia doesn't live in a country where the managers of the pharmaceutical company live and can be arrested.
Can the managers of the pharmaceutical company really be arrested in the US? Arrests are for poor people.
As Matt Levine would say: inefficacious cancer drugs sold in the American market would be egregious securities fraud[1] if the shareholders are not informed by company offices ahead of time. The resulting shareholder lawsuit may cost some managers their jobs. There is also the (minute) risk of getting Luigi'd by someone a state over, whose loved one they suspected to have gotten a bad batch and didn't get better.
1. "Everything is securities fraud" is a running series showing the breadth and depth of how shareholders exercise their rights in creative ways.
They will both die. Cancer treatment is largely useless (this is an editorial statement) Survival statistics are largely dependent on early detection. Detect the cancer early, you live longer after treatment.
This is an oft-refuted trope that does harm to patients. Numerous randomized phase 3 studies show meaningful survival advantages for modern treatments.
> Cancer treatment is largely useless
Cancer treatment effectiveness has improved substantially, with many treatments now achieving high cure rates or significantly extending survival.
Highly effective treatments:
Surgery remains the most curative treatment when cancer is localized and can be completely removed. Complete surgical resection often leads to cure for early-stage solid tumors.
Chemotherapy can be curative for several cancers, particularly blood cancers like leukemias and lymphomas. Some testicular cancers and certain pediatric cancers also respond extremely well to chemotherapy alone.
Radiation therapy achieves excellent local control and can be curative, especially when combined with surgery or chemotherapy. It’s particularly effective for head and neck cancers, early-stage lung cancers, and certain brain tumors.
Revolutionary newer treatments:
Immunotherapy has transformed outcomes for melanoma, lung cancer, kidney cancer, and others. Some patients with advanced disease achieve long-term remissions that were previously impossible.
Targeted therapies work exceptionally well when tumors have specific genetic mutations. Examples include imatinib for chronic myeloid leukemia (transforming a fatal disease into a manageable condition) and HER2-targeted drugs for breast cancer.
CAR-T cell therapy has achieved remarkable results in certain blood cancers that failed other treatments, with some patients achieving complete remissions.
Combination approaches:
Modern treatment often combines multiple modalities - surgery plus chemotherapy plus radiation, or immunotherapy plus targeted therapy. These combinations frequently outperform single treatments.
Current limitations:
Some cancers like glioblastoma and pancreatic cancer still have limited treatment options, though research continues. Metastatic disease remains challenging, though increasingly manageable as a chronic condition rather than immediately fatal.
Does that mean that generics really are worse than the brand pharmaceuticals. Or are they binned the same way?
In the UK I know the NHS buys generics, which implies they are effective, but I wonder.
here in Canada the active ingredient must be identical in identical quantity but the binding agents, excipient, and propellant are proprietary. The generics have to have the same bioavailability +-20%.In some drugs it doesn't matter, in others there is a world of difference.
I pay the 2$ it cost for brand name ventolin (my insurance cover the cost generic and I pay the difference) as the generic give asthma attack. But I would not pay one cent more for the brand name Vyvaanse. Effect wise the generic is indistinguishable (but damm the pills colors make them looks like a cheap gray market knock-off).
My wife has a paper from her oncologist for original femara because the generic made her faint a few times ( the insurance cover the whole cost because of that paper)
As a layman who fortunately has never had to deal with any "serious" medicine, how would I know which drug is good-enough is generic form, and which should be the brand name? To someone not in the know, +/-20% bioavailability sounds like a lot. Hopefully, the doctor will account for that when prescribing it, and know which way the 20% goes.
You also make it sound like 2$ isn't much to go from the generic to brand-name Ventolin. How much is too much? And is there a difference between generics of the same drug (I assume multiple manufacturers can actually produce generics) and how do you know which is better?
Generally it’s different companies manufacturing generics.
Instead this mostly comes down to how effective each countries regulations are.
This is also my understanding, but perhaps I am meant to understand that to be the case.
In my experience as a medically complicated person, generics generally work, but may have different side effects, both in scale and style. One of the worst was a duloxetine generic that came on so hard and strong that I felt serontoninised.
My friend the John the Pharmacist explained that the binders etc can accelerate absorption. His advice was be careful the first two days of a new generic formulation.
I would assume the NHS (like the TGA here in Oz) looks _very_ carefully at the side-affect profile before they buy any particular generic. Government agencies tend to try not to poison voters.
Generics lack the ownership of the intellectual property, but that’s about it
Generics are effective
There can be variances. I’ve measured it with my blood pressure a few times when the pharmacy swaps manufacturers.
Generics tends to be different companies altogether.
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.
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.
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.
Too mind-fogged to help you out here..
just wanted to point ou his most famous patent, the Einstein-Szilard fridge
(considerably less famous than the Einstein-Szilard letter, so I feel there's another argument for or against technocracy right there)
Because of concerns how toxic ammonia was, and how common leaks. Turned out to be useful many decades later when they were designing the cold chain for the H Bomb before solid duterium/lithium came along.
Ah yes because technocrats are never prone to groupthink or missing the forest because of the trees, et cetera.
There was a fascinating article I read years back about how much of China’s top leadership had engineering degrees, unlike in western countries. Then the article pointed out how that led to things like the one-child act based on research in the 1970s predicting mass starvation. That one child policy is now leading to possible demographic collapse after causing decades of social strife.
Be careful what you wish for, as you’re possibly a variable which could optimized out.
Alternatively consider the long term ramifications of leaving pandemic responses purely in the hands of unelected epidemiologists whose primary focus is a virus and not the overall welfare of a population. Those are not the same thing after all, even if they seem like it at first glance.
IMHO, alternative means of thinking are needed in a governmental system for the best overall outcomes.
hence (dys/u)topia above. I think Szilard was off his rocker when he proposed this, it was before he had much to do with Teller. I suspect after the events of the bomb, he might have changed his mind.
(he wrote rather bad scifi about talking to dolphins. Somebody else, Pierre Boule wrote it much more sexy/exciting, that became "the day of the dolphin")
Ah it wasn’t quite clear if you were for or against the notion.
Bad dolphin sci-fi sounds a bit too much for my tastes. Though it’s often the border line crazy folks who give us some of the best ideas or stories. Though they also often need refinement by, uh, more standard people. I say that as an ADHDer who sometimes benefits from the same.
See more rational for needing mixed viewpoints!
I don’t see how. FDA is widely respected.
The FDA has been approving generics from factories known to have repeatedly failed prior audits or had products recalled for quality issues without re-inspecting the factories or inspecting the drugs on import. And they're doing it via a special process that bypasses the ordinary review process and over the objections of many of the inspectors.
15 years ago the president was widely respected.
16 years ago not so much.
In both cases, the FDA was generally run and staffed by non-political people who were at least vaguely competent. I have plenty of issues with how the FDA operated, but it didn’t matter much who was president.
Today, most of the Cabinet positions are held by people who love to talk, who are generally extremely wealthy and/or well connected, and who are generally unqualified for their jobs. And, even more relevantly, they have been very heavily interfering in the operation of their respective departments.
Is it?
Australia wont import FDA certified beef. For great reason.
I think you mean USDA.
Australia doesn’t allow most USDA beef because of strict biosecurity rules.
Australia’s one of the world’s biggest beef exporters. There’s not much incentive for them to open the door to a competitor unless the protocols align perfectly.
So the FDA has no hand in Beef?
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Oh man did rfk jr actually do something with flouride, like directly out of the movie? I haven't been paying a ton of attention to rfk's actions.
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.
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I actually read the actual study on Lancet. unfortunately for you, your vile prejudice can not be justified by this study.
India isn’t even mentioned in the article.