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Quick question. Title says "generic", but obviously there is a massive economic interest in switching people from generics to non-generics. Is this contaminati

Quick question. Title says "generic", but obviously there is a massive economic interest in switching people from generics to non-generics. Is this contamination also possible in non-generics???

copperx 7y ago
Sure, it is possible, but because the brand name passed the carcinogenicity tests in animals, and if the manufacturer kept their same suppliers and formulation, the risk should be much lower. Whether that's true or not in practice is a different matter. But yes, I would have more confidence in a brand name after this report, which makes me cynical about the intentions of the reporting in the first place. Maybe I'm totally being manipulated by big pharma, but I'll switch my medication to brand name as soon as possible, and that's just because my insurance is good. Very few people have that option.
- gus_massa 7y ago
  > the brand name passed the carcinogenicity tests in animals, and if the manufacturer kept their same suppliers and formulation I really doubt this is the common case. The studies with animals and the clinical studies with human for safety are very small, so I guess they use a special batch. For production at scale they probably use some industrial method that is cheaper. They may also change the provider, or build it in another factory they own in other country. Also, every drug has precursors, and has precursors have precursors, you can't produce all of them so you must buy some. And with many of them there are more possibilities of changes that introduce contamination. What you get with a brand name is more quality control in the incoming products, more quality control in the process and more quality control in the final product. (And also more marketing, sometimes it is only marketing.)
- Scoundreller 7y ago
  The problem is that big pharma can (and do!) change their chemical synthesis process for its APIs. Without going through all the same testing again.
jessaustin 7y ago
According to TFA, Novartis, the inventor of (non-generic) Diovan, found the NDMA when they bought some (generic) Valsartan from Huahai. They were the first customer to test thoroughly enough to find it. So, contamination in non-generics is possible, but probably less likely. Actually the NDMA wasn't produced in the original manufacturing process designated for Diovan and Valsartan, but Huahai used a different process to save money.

Quick question. Title says "generic", but obviously there is a massive economic interest in switching people from generics to non-generics. Is this contamination also possible in non-generics???

copperx 7y ago

Sure, it is possible, but because the brand name passed the carcinogenicity tests in animals, and if the manufacturer kept their same suppliers and formulation, the risk should be much lower. Whether that's true or not in practice is a different matter. But yes, I would have more confidence in a brand name after this report, which makes me cynical about the intentions of the reporting in the first place. Maybe I'm totally being manipulated by big pharma, but I'll switch my medication to brand name as soon as possible, and that's just because my insurance is good. Very few people have that option.

gus_massa 7y ago
> the brand name passed the carcinogenicity tests in animals, and if the manufacturer kept their same suppliers and formulation I really doubt this is the common case. The studies with animals and the clinical studies with human for safety are very small, so I guess they use a special batch. For production at scale they probably use some industrial method that is cheaper. They may also change the provider, or build it in another factory they own in other country. Also, every drug has precursors, and has precursors have precursors, you can't produce all of them so you must buy some. And with many of them there are more possibilities of changes that introduce contamination. What you get with a brand name is more quality control in the incoming products, more quality control in the process and more quality control in the final product. (And also more marketing, sometimes it is only marketing.)
Scoundreller 7y ago
The problem is that big pharma can (and do!) change their chemical synthesis process for its APIs. Without going through all the same testing again.

jessaustin 7y ago

According to TFA, Novartis, the inventor of (non-generic) Diovan, found the NDMA when they bought some (generic) Valsartan from Huahai. They were the first customer to test thoroughly enough to find it. So, contamination in non-generics is possible, but probably less likely. Actually the NDMA wasn't produced in the original manufacturing process designated for Diovan and Valsartan, but Huahai used a different process to save money.