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

111–120 of 142 posts

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

#111

Post by refurb »

pessimizer wrote: post #64
fucking_tragedy wrote: post #4

Earlier quoted context omitted.

> These comments, if true, lend credability that the FDA is more regulatory capture than actual useful regulation. It lends more credibility to the fact that the FDA is notoriously underfunded when it comes to ensuring the safety of drugs[1]. [1] https://www.ncbi.nlm.nih.gov/books/NBK52926/

An industry that sells drugs would want the regulating authority to be underfunded when it comes to insuring the safety of drugs.

Really? Back when the FDA was underfunded in the 80s, there was a massive backlog in drug approvals that cost drug makers billions. They happily coughed up fees to better find the FDA.

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

#112

Post by refurb »

perl4ever wrote: post #86
refurb wrote: post #27

Earlier quoted context omitted.

The FDA approves generics based on bioequivalence, not just chemical composition. In order to be an "AB" rated generic (and used as a substitute for the branded product), the generic has to fall between 80-125% bioequivalence of the brand, which measure dissolution and absorption. The fillers in the generic don't have to be the same as the branded product, but the drug does have to behave the same as the branded prod…

There was an issue I read about with a drug where they did not test all the different dosages of a generic, and I think the behavior of one of the doses was not as expected because it didn't dissolve well or something. This was a psychiatric drug, and so of course, reports of problems went unheeded for years because patients were assumed to be imagining things. Saying "the drug does have to behave the same as the bra…

Yup. There have been a handful of approved generics that didn’t have bioequivalence to the branded.

It’s not a perfect process, but it works in nearly all the cases.

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

#113

Post by AstralStorm »

s1artibartfast wrote: post #106
dahfizz wrote: post #24

Earlier quoted context omitted.

I agree, I think the statement is ambiguous. 1% of all products (e.g. one pill from every bottle of 100 pills) being tested seems like plenty. 1% of shipments (1 out of 100 shipments is sampled) seems insufficient.

The think the accurate statement is that 1% or product lines have had a shipment sampled. The FDA is not in the business of performing QA testing, that is the job of the manufacturer. It is better to think of them as a legislative body.

Maybe a special duty office for this should be created. (Like for meat and meat products in EU.)

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

#115

Post by AstralStorm »

joe_the_user wrote: post #104
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.

The FDA is intended to be this with teeth - clearly it has rather corrupted. What makes you imagine a private organization would be better?

It's not corrupted, but too small and underfunded, while the scope is huge. Really.

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

#116

Post by AstralStorm »

o09rdk wrote: post #100
JMTQp8lwXL wrote: post #6

I wonder if the point of this, is to have us weigh getting "brand name" more seriously. There is no sensible reason to pay a premium for brand name if the generic is chemically equivalent.

This another in a long string of failures in generic regulations that underscore broader problems pertaining to regulation in the US healthcare system. There's this theoretical land of regulation, what the consumers and citizens are encouraged to presume, and what actually happens. It's been common, for instance, for people to repeatedly be berated for paying more for name brand. Studies in fact, of the public health…

I only buy generics from known reputable manufacturers, these are mostly locally made EU ones, bit more expensive than big pharma, say Teva or even maybe Sanofi (they're very likely local though) but at least predictable and it helps local business.

(Polish, Czech and Slovakian.)

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

#117

Post by AstralStorm »

braindead_in wrote: post #58
refurb wrote: post #9

Earlier quoted context omitted.

It's an issue in Canada[1] and the EU[2]. [1] https://www.bcpharmacists.org/news/update-august-18-2018-dru... [2] https://www.ema.europa.eu/en/medicines/human/referrals/angio...

What about India? Are Indian generics affected as well?

Very likely too, including other issues previously found I'd expect anything to happen there.

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

#118

Post by AstralStorm »

userbinator wrote: post #105

From the Wikipedia page https://en.wikipedia.org/wiki/N-Nitrosodimethylamine "NDMA is a yellow, oily liquid with a faint, characteristic odor and a sweet taste." "characteristic" doesn't say much, but I often wonder how we know about the taste of a highly toxic chemical like this one --- and if someone died for it.

You wouldn't taste it in a drug. Low concentrations and bound in binders or hidden by taste additives in syrups.

Typically researchers tasted small samples, not too risky. Usually characteristic has a specific chemical kind of taste.

Yes, people have tasted solvents, glue and more nasty stuff.

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

#119

Post by RachelF »

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 it is not just the generic, but the original too:

https://www.smh.com.au/business/consumer-affairs/regulators-...

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

#120

Post by AstralStorm »

dghughes wrote: post #50

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.

Technically FDA handles supplements and foods too, but they're really too small to handle the volume of this market.
Post reply on HN