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

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/

> 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 at random, that is totally normal and what I'd expect them to do.

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.

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.

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.

From the NDMA wiki: [NDMA] is also used to create cancer in rats for cancer research.

That is super alarming.

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

If there was a market behind it, then there might be a way. But good luck getting Samsung to tell you where their cobalt came from, or if some generic drug was made in a dangerous lab. Even if you knew it was Generic Factory 1736, it’s hard to know if that’s good or bad.

That's already existed for decades, so why aren't you paying for it then?

It's primarily based around different characteristics of how the medication dissolves in the patient's stomach, or the differences between fillers and binders.

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.

My physician had prescribed "Diovan, not Valsartan" last year because of this. My pharmacist called me up as I was driving home from the physician's office. He assured me that he wasn't buying anything from that Chinese company, and observed that I'd be going from $65 per three months to $365 per three months. OK, generic it is...

https://www.amazon.in/Bottle-Lies-Inside-Story-Generic-ebook...

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

The FDA's legal basis to regulate medicines is actually incredibly weak and really hasn't changed much since the 1930s. One of the examples is exactly this case. The FDA only regulates finished medicines in two cases a) brand name or b) generic equivalents. Leaving aside brand name drugs for the moment getting approval to sell a generic equivalent doesn't look anything like what you would expect. What people generally think is that generic drugs are 'copies' of existing brand name drugs and the FDA cares about making sure the generic guys are producing the same drug as the brand name one.

This isn't what happens at all. A manufacturer has to demonstrate similar blood level uptake as the FDA approved equivalent drug using a very similar approval process for the brand name drug. This requires an incredible effort that is substantially the same as getting an original drug approved.

The bottom line is that the FDA doesn't examine the on-going manufacturing of the drug much or supplier reliability much at all. If a manufacturer can pass blood level equivalence nothing else really matters. This equivalence is only valid for the direct manufacturting producer of the drug, not the company marketing it. The reality is that if you want to get FDA approval for a generic you might as well partner with a firm outside the US that knows how to handle this process because its a waste of money jumping through FDA hoops to certify a new facility in the US.

Once you have proved equivalance you can start selling the drug. At this point, the FDA is basically done. The FDA basically dones't care anymore and has very weak sanctions to enforce safety compliance.

The FDA can't do anything about this situation on its own; the way drugs are approved is directly established by law that dates back to the 1930s. I notice a lot of people in this thread suggesting that FDA leadership is bought off and does the work of the drugs companies. I assure you this is not the case.

FDA oversight of pharmacutecial ingredients is accomplished under an entirely different legal regime that has nothing to do with drug approval whatsoever.

[1]https://www.bcpharmacists.org/news/update-august-18-2018-dru...

[2]https://www.ema.europa.eu/en/medicines/human/referrals/angio...

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.

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.

Shower heads are very concerning. Never seen those warnings.

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 totally being manipulated by big pharma, but I'll switch my medication to brand name as soon as possible, and that's just because my insurance is good. Very few people have that option.

A virally popular device (non-prescription and cheap, for god’s sake) to detect toxicity levels, and connected app to visualize the health impact will serve as a wake-up call.

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.

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.