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

bloomberg.com

91–100 of 142 posts

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

#91

> 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…

> Not if you actually fine the American importers into the ground.

Sounds like an invitation for the importer to be a nearly judgement proof shell that just gets abandoned at the first sign of trouble.

> And ban the at fault over seas companies.

That part sounds more effective.

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

#92

Earlier quoted context omitted.

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.

Someone really needs to create a version of the cloud to butt extension that replaces "blockchain" with "database".

What you're describing is a useful application for a _database_. Mixing "blockchain" into it would only hurt the viability of the database, not bring any obvious benefit.

Your comment makes so much more sense with the word database:

"A federally supported database used as a public notary and other official functions, as you mentioned, seems like it may have a place in the future."

Indeed.

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

#93
post #90
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.

Very ambiguous. Generally how it works is you submit a proposed purity level to the FDA, with rationale and backup by your own validated analyses. The FDA dives into it and says “this is reasonable” or “this won’t work” or “based on the chemistry, you need to test for X also”. Then they require you to “release” any product you make, showing that it conforms to the agreed upon purity. If it fails, they expect you to f…

“much of the regulation is based on good faith simply because the manpower required to verify everything made would be massive”

This is where I wish there were more tolerance for enough government spending to employ as many people as it would take to test properly. We’re talking about medication being used multiple times a day for long term-amongst many uses.

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

#94
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.

Even 1% shipments would be okay, IMO. I interpreted it as "99% of drug products never get inspected", which is way worse.

It’s more like the later than I’m comfortable with tolerating.

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

#95
Probably the best source of information is from this long-time blogging Medicinal Chemist here:

https://blogs.sciencemag.org/pipeline/archives/2019/01/04/th...

This story has some speculation about why different molecules of the same therapeutic category are implicated:

https://www.gmp-compliance.org/gmp-news/valsartan-what-cause...

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

#96
post #91

> 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…

> Not if you actually fine the American importers into the ground. Sounds like an invitation for the importer to be a nearly judgement proof shell that just gets abandoned at the first sign of trouble. > And ban the at fault over seas companies. That part sounds more effective.

Jail time for high level execs will make sure that they don't cut cost by neglecting quality.

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

#97
post #93
post #90

Earlier quoted context omitted.

Very ambiguous. Generally how it works is you submit a proposed purity level to the FDA, with rationale and backup by your own validated analyses. The FDA dives into it and says “this is reasonable” or “this won’t work” or “based on the chemistry, you need to test for X also”. Then they require you to “release” any product you make, showing that it conforms to the agreed upon purity. If it fails, they expect you to f…

“much of the regulation is based on good faith simply because the manpower required to verify everything made would be massive” This is where I wish there were more tolerance for enough government spending to employ as many people as it would take to test properly. We’re talking about medication being used multiple times a day for long term-amongst many uses.

The FDA has been downsized many times over the past three decades. So what we're seeing here is not at all unexpected.

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

#98
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.

For supplements you should look at labdoor.com. They do independent lab tests for label accuracy and ingredient safety.

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

#99
post #91

Earlier quoted context omitted.

> Not if you actually fine the American importers into the ground. Sounds like an invitation for the importer to be a nearly judgement proof shell that just gets abandoned at the first sign of trouble. > And ban the at fault over seas companies. That part sounds more effective.

Jail time for high level execs will make sure that they don't cut cost by neglecting quality.

Sure, but it's not clear-cut. Executives can be (in good faith) fooled and that's a problem. You can't just jail people just because. I'm happy seeing the Purdue Pharma people get strung up, but I think we need due process and reasonable doubt as well.

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

#100

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 economics of it, why people pay more for name brands, trying to understand it as if there are deficiencies in consumer reasoning.

This is despite repeated problems with generic suppliers overseas, mainly India, diluting medications. This was uncovered, problems were corrected, and then it happened again.

And now this.

So who exactly is the rational purchaser? The person who buys generics under the assumption that they are chemically equivalent, or the skeptic who prefers to have transparency about where their medications are coming from, and purchases brand names?

My point isn't to berate the FDA as incompetent -- I think they're overburdened -- but I do think there are broader problems involving a disconnect between how we discuss regulatory systems in the US and what actually happens. To me, this is just the tip of the iceberg. My personal opinion is the FDA needs to focus solely on this kind of problem -- ensuring drugs are what they are labeled to be -- with maybe some substantial research into effectiveness -- and to drop its regulatory role as drug police.

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