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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.

#61

Post by KingMachiavelli »

lostmsu wrote: post #19
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…

>> 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 more regulatory capture than actual useful regulation. I wonder though if this statement misrepresents the facts. If they check only 1% of the entire import volume a…

1% of the entire import volume would far more than necessary to test so it made more sense that it's only 1% of batches or shipments.

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

#62

Post by froasty »

Really? It's 2019, there is no argument to be had over this.

Impurity problems have occasionally come up over the years, but they have largely been addressed quickly by existing regulations. And at no point have they ever approached the level of risk posed by the illnesses they are prescribed to treat.

While the risk of impurities in the generic drug supply certainly warrant research, the percentage of issues again doesn't approach significance with comparison to these pervasive illnesses.

Nothing is risk-free. Eating food has risk, taking paracetamol has risk, getting blood drawn has risk.

Saying something has risk without talking about the amount of risk and the context of the risks it mitigates is pointless.

Drug impurities in generics introduce negligible amounts of risk. Eating peanuts in public or going for a drive is much riskier, and we almost all do those things without a second thought. By contrast, access to affordable drugs mitigate huge risks: the illnesses we medicate can, did and do cause horrific harm up to and including death, and do so very well.

The pharmaceutical industry is not immune to criticism, it is just they have weathered all the reasonable criticism leveled at them. If you are willing to drive in a car, taking generics that could should be a complete non-issue for you.

In an era of fake news and increasing doubt in the medical establishment, publishing reports like this is not only irresponsible, but unethical. This only adds fuel to the fire of unwarranted skepticism towards our medical system.

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

#63

Post by brianpgordon »

froasty wrote: post #62

Really? It's 2019, there is no argument to be had over this. Impurity problems have occasionally come up over the years, but they have largely been addressed quickly by existing regulations. And at no point have they ever approached the level of risk posed by the illnesses they are prescribed to treat. While the risk of impurities in the generic drug supply certainly warrant research, the percentage of issues again d…

I thought the article did a decent job of explaining exactly what the problem is in this case and communicating the scale of the risk. Your comment, on the other hand, sounds like a kneejerk dismissal entirely based on the headline not agreeing with what you thought was true.

Yes generics have proven to be broadly safe. That doesn't mean there aren't still issues that need to be addressed by tweaking or adding regulation. Yes even with carcinogens the contaminated generics are probably better than taking nothing. That doesn't mean that the contamination is acceptable.

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

#64

Post by pessimizer »

fucking_tragedy wrote: post #4
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…

> 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.

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

#65

Post by KingMachiavelli »

froasty wrote: post #62

Really? It's 2019, there is no argument to be had over this. Impurity problems have occasionally come up over the years, but they have largely been addressed quickly by existing regulations. And at no point have they ever approached the level of risk posed by the illnesses they are prescribed to treat. While the risk of impurities in the generic drug supply certainly warrant research, the percentage of issues again d…

Exactly, I sort of failed to highlight this directly in my comment but the fact that the article focuses on a single case of tainted generics vs who knows how many people die each year waiting for drugs to be approved and/or imported is pretty insane.

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

#66

Post by coliveira »

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.

Companies don't want to do their job, they say this is "excessive regulation that is killing the economy".

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

#67

Post by robocat »

The solution is to have three classes of quality for every drug: lower class, middle class, and upper class.

The lower class drugs must have pills with Chinese characters on them, and packaging with Chinese writing, and an English insert. They get minimal testing.

The upper class pills have American flags impressed on them, cost a metric tonne more, but are tested rigorously by private agencies (that are paid from the extra cost).

The aim here is propoganda: have people associate poor quality with Chinese goods and good quality with American goods.

(There is no middle class of drugs: if you are a middle earner you either decide to be either cheap, or to keep up appearances).

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

#68

Post by copperx »

robocat wrote: post #67

The solution is to have three classes of quality for every drug: lower class, middle class, and upper class. The lower class drugs must have pills with Chinese characters on them, and packaging with Chinese writing, and an English insert. They get minimal testing. The upper class pills have American flags impressed on them, cost a metric tonne more, but are tested rigorously by private agencies (that are paid from th…

> have people associate poor quality with Chinese goods

Nobody is going to associate poor quality with Chinese goods while iPhones and most luxury continue to be made in China.

> keep up appearances

Nobody should know what drugs I'm on, much less the brand I take.

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

#69

Post by arandr0x »

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.

For food at least I think it may be somewhat amenable to some of the newer fingerprinting techniques (e.g. using DNA microarrays). I've been wondering why origin/content/quality validation for food based on actual biological science doesn't exist for years. I did biochemistry for undergrad, and some of those labs could be done in the average RV kitchen, and others could be packaged into test kits.

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

#70

Post by el_benhameen »

azinman2 wrote: post #52
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...

They offer that but little additional information. Is it just Zantac the commercial brand? How do I know if I’m affected?

Not an ad, just my experience: I googled the company, Valisure, that was mentioned in this article and another in the NYT. In addition to selling drugs that they've tested, they'll also take a sample and test your own prescriptions. Price is $40 for their "impurities/carcinogen" analysis. Worry may well be overblown at this point, but my kid was prescribed ranitidine and some peace of mind is worth 40 bucks to me.
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