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Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

bloomberg.com

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Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#71

Post by sjg007 »

el_benhameen wrote: post #59
cooljacob204 wrote: post #56

Earlier quoted context omitted.

And I would have never learned about this unless I was surfing hacker news. Bleh. From the NDMA wiki: [NDMA] is also used to create cancer in rats for cancer research. That is super alarming.

Yep. Just happened to see this [1] article out of the corner of my eye while browsing. Really concerning. And from the sound of it, this Valisure place, not the FDA, is the one who discovered the issue. One wonders what use regulators are these days. My infant daughter was prescribed ranitidine for reflux from age 3 months to about age 6 months. Anyone with more chemistry knowledge than me want to venture any guesses…

Do you have any of the pills left? You could get the leftovers tested. But I would ask your pediatrician. I would guess you probably don't need to be specifically concerned.

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#72

Post by gus_massa »

copperx wrote: post #26
wtvanhest wrote: post #16

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???

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 to…

> 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.)

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#73

Post by BlueGh0st »

azinman2 wrote: post #55
aresant wrote: post #14

I would pay good money for a supply chain based “consumer reports” so I actually know what’s in my products eg - medicines! - supplements - food - clothing Clearly in the USA their is gigantic demand for organic / harmful chemical free products.

This could be an interesting case for blockchains. I normally am not a proponent of seeing everything thru that lens, but having a proper chain that is publicly verifiable is in the public’s interest. That said, there’s not a lot of incentive for people to reveal their supply chains — it’s often trade secret or hidden for a reason. If there was a market behind it, then there might be a way. But good luck getting Sams…

I carry a lot of guilt for having "oh, blockchains could help" thoughts quite a lot. A federally supported blockchain used as a public notary and other official functions, as you mentioned, seems like it may have a place in the future.

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#74

Post by el_benhameen »

sjg007 wrote: post #71
el_benhameen wrote: post #59

Earlier quoted context omitted.

Yep. Just happened to see this [1] article out of the corner of my eye while browsing. Really concerning. And from the sound of it, this Valisure place, not the FDA, is the one who discovered the issue. One wonders what use regulators are these days. My infant daughter was prescribed ranitidine for reflux from age 3 months to about age 6 months. Anyone with more chemistry knowledge than me want to venture any guesses…

Do you have any of the pills left? You could get the leftovers tested. But I would ask your pediatrician. I would guess you probably don't need to be specifically concerned.

Yeah, I replied to another commenter, but I have some of the syrup left over and I'm sending it to be tested. Turns out the folks who discovered this have publicly-available testing. I'm thinking that the limited duration is a good thing. Fingers crossed.

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#76

Post by jstewartmobile »

arcticbull wrote: post #53
bgorman wrote: post #48

Earlier quoted context omitted.

Regulatory capture is a separate issue from privatization. Regulatory capture is when there is a powerful government regulator, but it has been compromised by the companies and is used to prevent competition to those companies. For example - Boeing successfully convinced federal government regulators to prevent Bombardier from selling a 737 competitor in the US.

Indeed, although I suggest that that comes about in part because the government fails to fund these organizations to the level required for self-sufficiency forcing them to outsource more and more of the work onto the only "competent body" willing to take on the job free of charge: the companies themselves. This creates a relationship where the companies have a disproportionate share of the power, and can dictate thi…

That's all beside the point.

As long as outside entities can dangle future low-effort, high-compensation posts to government officials in exchange for present favors, regulatory capture will remain a fact of life.

It's an incredibly tough problem. Even if we prohibited regulators from ever working for the regulated, it's so easy to get around that with nonprofits and shell corporations.

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#77

Post by refurb »

cooljacob204 wrote: post #56
stock_toaster wrote: post #42

Apparently NDMA has also been found in Zantac (ranitidine), a common OTC heartburn medicine. The FDA has issued an alert - https://www.fda.gov/safety/medwatch-safety-alerts-human-medi...

And I would have never learned about this unless I was surfing hacker news. Bleh. From the NDMA wiki: [NDMA] is also used to create cancer in rats for cancer research. That is super alarming.

It's a different issue than the valsarten issue. Valisure is suggesting that ranitidine breaks down itself into NDMA, which, as an organic chemist, I guess could happen to a small degree based on the structure[1], but it would be hard to mimic the conditions inside the body in a lab.

The Valisure petition speculated that the source of the NDMA was the result of the “inherent instability” of the ranitidine molecule, which can degrade under certain conditions, such as when it is digested, to create NDMA.

[1]https://en.wikipedia.org/wiki/Ranitidine

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#78

Post by Scoundreller »

pkaye wrote: post #7

Are these problems only limited to the US? Do Canada or the EU have similar issues? Do they not import chemicals from similar suppliers or do they screen the better?

Pretty much worldwide, since there's usually only a few manufacturers of the Active Pharma Ingredients supplying the whole market.

Scale matters.

In this case, the manufacturer came up with a new technique for manufacturing the API. They failed to account for these very small molecule impurity side-products in their model/testing.

They probably filtered out a lot of it in their purification process and still met USP standards, but 99% or 99.9% pure still leaves a risk for potent side products.

Sometimes these side-products are tested for, but you have to know what to look for. A tiny blip may not be elucidated.

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#79

Post by Scoundreller »

copperx wrote: post #26
wtvanhest wrote: post #16

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???

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 to…

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.

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#80

Post by Scoundreller »

zkms wrote: post #44
knolax wrote: post #3

> Some of the contaminated valsartan contains as much as 17 micrograms of NDMA in a single pill. That’s equivalent to eating 48 pounds of bacon. The FDA estimates that for every 8,000 people who took the highest dose of contaminated valsartan daily for four years, there would be one additional occurrence of cancer. Given the relatively small significance and the fact that this article was published in an issue with t…

> 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 accura…

> 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.

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