3 ms·
> Given the relatively small significance and the fact that this article was published in an issue with the blurb "Can You Trust Generics?" on the cover, I'm go
by zkms 7y ago
> Given the relatively small significance and the fact that this article was published in an issue with the blurb "Can You Trust Generics?" on the cover, I'm gonna say this is just more FUD from Bloomberg.
It's not a small significance, and it's not FUD. It's admittedly possible to take some measured numbers for the prevalence of one of the nitrosamines, put that through a dose-response model (of controversial accuracy) and come up with low-sounding numbers of expected cancers, but that's not enough to dismiss the issue.
Nitrosamines are notorious carcinogens, the side-reactions that produced them is well-known (if this comment (https://blogs.sciencemag.org/pipeline/archives/2019/01/04/the-sartan-contamination-story#comment-299170 https://blogs.sciencemag.org/pipeline/archives/2019/01/04/th...) is to be believed, known since the 1930s), and detecting these genotoxic impurities is feasible without exotic analytical equipment.
The mechanics of the synthesis routes should never have allowed production of those impurities, the active pharmaceutical ingredient should have been monitored for these impurities as well, and this aberration should have been discovered far earlier than it actually was.
It's a lot like foreign object debris in aircraft, or retained surgical instruments inside a patient. Neither are a guaranteed death sentence, but they're harmful, utterly avoidable, and their prevalence is a good indicator of careless/inappropriate working practices and inadequate monitoring procedures. If their procedures couldn't detect these nitrosamines for years -- what else is being let through? Heavy metals? Pyrogens? Some other class of toxic chemicals? Inadequate/overly-high active ingredient dose/concentration?
I've installed avionics inside other people's aircraft and I was careful to not leave behind any tools / bits of wire insulation / snipped-off wires / screws / etc floating around. Yes, the probability that a single bit of wire will find its way onto uninsulated connectors is small, but that argument is not an excuse for sloppy working methods. With life-critical systems, it's not OK to be careless just because someone else might catch the problem or because there's other subsystems that'll attenuate the severity of the fault.
- Scoundreller 7y ago> retained surgical instruments inside a patient. > If their procedures couldn't detect these nitrosamines for years -- what else is being let through? Heavy metals? Pyrogens? Some other class of toxic chemicals? Inadequate/overly-high active ingredient dose/concentration? Leaving behind instruments in a patient is a "never event". The accepted amount is literally zero. When it comes to heavy metals, there are standards of acceptability, because you'll never get all of the lead out of a sample of calcium. Same for pyrogens. No active pharma ingredient is 100.000000% pure. And the cost of making them so would defeat the purpose. At some point you say: "Well, the air you're breathing isn't free of cancerous pollution either, when should we spend dollars on that instead of safer pills?" because there is a line between the two.
- jessaustin 7y agoOne is discrete while the other is continuous, so that's different. Still, the proposition "a single pill is equivalent to 48 pounds of bacon" seems to put us back in the discrete domain...
- Scoundreller 7y agoEven the continuous curve has a minimum threshold. One molecule of anything isn't going to kill you. When it comes to bacon, it's not only the NDMA that can kill you :)