Hacker News Board Hacker News, browsed like a classic message board
Live data from Hacker News

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

bloomberg.com

Post reply on HN
Print view View original

41–50 of 142 posts

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

#41

Post by kevingadd »

KingMachiavelli wrote: post #2

> By 2014, the FDA had closed its offices in Shanghai and Guangzhou, leaving only the Beijing office with inspectors who could visit Chinese factories on short notice. > The FDA checks less than 1% of drugs for impurities or potency before letting them into the country. For a regulator body who's job it is to make sure medical products are safe and available. These comments, if true, lend credability that the FDA is…

Considering the fine American tradition (dramatically amplified in the last decade) of underfunding every important regulatory agency and then hollowing it out through other methods, it doesn't seem very surprising that the FDA is bad at checking products. Hard to imagine closing offices because of "regulatory capture", if anything the big US companies would want more enforcement on foreign generic drug manufacturers to secure their hold on the market.

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

#43

Post by cwkoss »

KingMachiavelli wrote: post #2

> By 2014, the FDA had closed its offices in Shanghai and Guangzhou, leaving only the Beijing office with inspectors who could visit Chinese factories on short notice. > The FDA checks less than 1% of drugs for impurities or potency before letting them into the country. For a regulator body who's job it is to make sure medical products are safe and available. These comments, if true, lend credability that the FDA is…

Seems like "every company in drug supply chain must independently test each batch of received drug via GC/MS. That company is liable for any impurities found downstream in un-rejected batches" would be a nice regulation.

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

#44

Post by zkms »

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 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/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.

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

#45

Post by arcticbull »

KingMachiavelli wrote: post #2

> By 2014, the FDA had closed its offices in Shanghai and Guangzhou, leaving only the Beijing office with inspectors who could visit Chinese factories on short notice. > The FDA checks less than 1% of drugs for impurities or potency before letting them into the country. For a regulator body who's job it is to make sure medical products are safe and available. These comments, if true, lend credability that the FDA is…

> For a regulator body who's job it is to make sure medical products are safe and available. These comments, if true, lend credability that the FDA is more regulatory capture than actual useful regulation.

This feels like a typical right-wing playbook item: defund and de-scope government organizations until they can't be successful, then point at how bad they are, and privatize them or shut them down. Government agencies don't work unless you pay for them.

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

#46

Post by pkaye »

sjg007 wrote: post #39
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?

It's an issue everywhere. Almost all generics are manufactured in India and China. And most with Chinese precursors.

Yeah but the article and some others are making it seem like something unique to the FDA. It seems to be a global issue and they all need to improve their quality control and testing processes.

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

#47

Post by luckydata »

cwkoss wrote: post #43
KingMachiavelli wrote: post #2

> By 2014, the FDA had closed its offices in Shanghai and Guangzhou, leaving only the Beijing office with inspectors who could visit Chinese factories on short notice. > The FDA checks less than 1% of drugs for impurities or potency before letting them into the country. For a regulator body who's job it is to make sure medical products are safe and available. These comments, if true, lend credability that the FDA is…

Seems like "every company in drug supply chain must independently test each batch of received drug via GC/MS. That company is liable for any impurities found downstream in un-rejected batches" would be a nice regulation.

yeah but the "muh job creators" crowd would never let anything this sensible become law.

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

#48

Post by bgorman »

arcticbull wrote: post #45
KingMachiavelli wrote: post #2

> By 2014, the FDA had closed its offices in Shanghai and Guangzhou, leaving only the Beijing office with inspectors who could visit Chinese factories on short notice. > The FDA checks less than 1% of drugs for impurities or potency before letting them into the country. For a regulator body who's job it is to make sure medical products are safe and available. These comments, if true, lend credability that the FDA is…

> For a regulator body who's job it is to make sure medical products are safe and available. These comments, if true, lend credability that the FDA is more regulatory capture than actual useful regulation. This feels like a typical right-wing playbook item: defund and de-scope government organizations until they can't be successful, then point at how bad they are, and privatize them or shut them down. Government agen…

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.

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

#49

Post by rjf72 »

newsreview1 wrote: post #35

Wow, to formulate a generic drug and export it to the U.S. requires the FDA stamp, but if you generate components used in manufacture of US-made drugs get literally no FDA oversight. How can this be?.

For what it's worth many things are like this. It's the same thing with genetically engineered products, also under FDA purview. There is 0 mandatory oversight. If you have the clearance to sell a potato, then you can produce any engineered potato you like and sell it with 0 oversight, testing, or additional requirements. All the FDA offers is a purely voluntary opt-in consultation. [1]

Perhaps unsurprisingly this [2] was the head of the FDA under our last president. He was appointed a newly created executive role, not entirely jokingly referenced as the 'czar of foods.' A Monsanto vice president and lobbyist whose career highlights included arguing that companies should be allowed to knowingly allow at least a very small amount of carcinogenic chemicals into foodstuffs. Seriously, that was the head of the US Food and Drug Administration for nearly 8 years.

[1] - https://www.fda.gov/food/food-new-plant-varieties/how-fda-re...

[2] - https://en.wikipedia.org/wiki/Michael_R._Taylor

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

#50

Post by dghughes »

Adding to this some people may not know unlike here in Canada supplements in the US are not regulated. Herein Canada they are treated as a drug and regulated by Health Canada.

There have been recalls of supplements from the US due to contamination or mislabeling (for example, adding stimulants or steroids but not disclosing that). Although supplements here in Canada can still be questionable in quality.

Post reply on HN