5 ms·

Widespread fraud in the generic drug industry

96 points by ravar 7y ago

radicalbyte 7y ago
This is the cause of drug shortages here in the EU. It has gotten so bad that the Dutch government are supporting moving the production of generics into the EU. That makes a lot of sense to me, it seems to be a smart strategic move to have drug production under your control. Just like it's smart to be self-sufficient in the production of food.
- AstralStorm 7y ago
  Yup, we're getting done of our generics from Slovenian Krka Group and locally made in Poland too. Some more expensive things mostly from Merck. A few but common from separate Polish manufacturers - sadly a few bigger ones were bought up by Valeant or Teva with concomitant price increase. They're pretty good, compared to random trash from India or China. They cannot match the volume, not even close, to be more than regional EU players.
paulsutter 7y ago
I would pay to see the book summarized in a “just the facts” format. Everything I can find is in a turgid storytelling format. For example: https://www.nytimes.com/2019/05/13/books/review/bottle-of-lies-katherine-eban.html https://www.nytimes.com/2019/05/13/books/review/bottle-of-li... The book itself is written in this same tedious style (first 56 pages available as a preview): https://books.google.com/books/about/Bottle_of_Lies.html?id=mGVzDwAAQBAJ&printsec=frontcover https://books.google.com/books/about/Bottle_of_Lies.html?id=...
- oicu812 7y ago
  I agree, even the audiobook was a chore to get through at 1.5x speed. However, it's not on GetAbstract yet: http://getabstract.com http://getabstract.com
jimbob45 7y ago
Well this is fascinating but the notes run out and I don't have three hours to listen to a podcast. Does anyone subscribe to this site that can share the notes?
- ravar 7y ago
  It's not a technical podcast so listening at 1.5 or 2x speed can really shorten the time demand with little lost information.
- cliff 7y ago
  It would be better to read the book she wrote, "Bottle of Lies". I highly recommend it.
  - utopian3 7y ago
    I imagine that is longer than the 3-hour podcast
    - pfranz 7y ago
      Correct! Audible clocked in at 14 hrs and 26 mins
Paperweight 7y ago
Semi-related: Even though it's been 123 years since Cornflakes were patented, generic breakfast cereal just isn't the same. Some of them are downright revolting (e.g. mini-wheat knockoffs) even though they're made in the USA. Many don't even use the same ingredients. I guess their target market is people who don't care about quality? At all?
- callmeal 7y ago
  >I guess their target market is people who don't care about quality? At all? No, their target market is people who have no other choice. This is what regulatory capture gets you.
- UnFleshedOne 7y ago
  I thought "generic breakfast cereal" is "quick oats"?
- r00fus 7y ago
  There is no such thing as "generic" cereal because it has no guaranteed stock ingredients. You have a white-label producer, and many store-brands that simply slap a label on that white-label product. Obviously if the goal is to sell a product that's cheaper than the name-brand (Kellog's in this case), it's clear that's a race-to-the-bottom in terms of quality
- jdietrich 7y ago
  Processed foods are far more complex and involve far more technology than you might imagine. The production process used by the original manufacturer is effectively a black box, so cloning a breakfast cereal involves a major reverse-engineering effort. The thoroughness of that effort is bounded by the need to undercut the original manufacturer on price, which may also affect the quality of ingredients.
  - derefr 7y ago
    > The production process used by the original manufacturer is effectively a black box Don't they patent that, too? Isn't that what the parent commentor is referring to when saying "it's been 123 years since Cornflakes were patented"—that the original manufacturer's exact factory design should be in the public domain by now?
shiftoutbox 7y ago
The fda knew aboutthis for years ; but it’s insanely hard to prove . Take Levothyroxine , a synthetic thyroid hormone brand names is Synthroid. Analogs ( generics ) sort of work but unless you abuse it it’s hard to tell if it working . Most of the time generic synthroid is as good as blue chalk . Then take insulin , no generic maker will attempt to make it; two reasons , if you fuckup insulin diabetics die . Secondly diabetics can rapidly tell if their insulin is good or not . It either lowers their blood sugar or it’s useless .
majos 7y ago
This is the second cautionary piece about generic drugs I’ve read in the past two days. The first was from last week’s Economist [1] and made a different point. It argued that generic drugs are such a viciously competitive market that the surviving manufacturers are those that cut the most corners. Corners cut range from outright fraud (as mentioned in this topic) to manufacture that is both highly consolidated and prone to just-rare-enough breakdowns that — because more reliable competitors have been priced out of the generics market — lead to sudden drastic shortages and the attendant problems for consumers. Zooming out a bit, it looks like a specific example of a wider trend of supply chains that are long and efficient until their fragility becomes clear thanks to a well-timed and well-placed break. I wonder what other specific products have a dysfunctional market like this? [1] https://www.economist.com/international/2019/09/14/a-dire-scarcity-of-drugs-is-worsening-in-part-because-they-are-so-cheap https://www.economist.com/international/2019/09/14/a-dire-sc...
User23 7y ago
More in the same vein from the always excellent Derek Lowe: https://blogs.sciencemag.org/pipeline/archives/2019/07/25/got-it-all-ready-for-you-mr-fda-inspector https://blogs.sciencemag.org/pipeline/archives/2019/07/25/go...
- Scoundreller 7y ago
  Anyone interested in this topic should read everything he’s ever written. The comments from anonymous insiders reminds me of HN.
TheOperator 7y ago
I remember being in the first wave of people where doctors noticed how generics were not working as well as the brand name drugs in a big way. Back when there was basically nothing in the news ever about generics not being as good as regular drugs and instead people were talking about how smart it was to buy generic. Generics are used to justify cutting insurance payments for the actual brand name medication. Years later after an investigation a decent chunk of generics actually went off the market because they were crap. This is a field that has faced unreasonably low levels of scrutiny historically. So it's no shock to see stories like this.

96 points by ravar 7y ago

This is the cause of drug shortages here in the EU. It has gotten so bad that the Dutch government are supporting moving the production of generics into the EU. That makes a lot of sense to me, it seems to be a smart strategic move to have drug production under your control. Just like it's smart to be self-sufficient in the production of food.

AstralStorm 7y ago
Yup, we're getting done of our generics from Slovenian Krka Group and locally made in Poland too. Some more expensive things mostly from Merck. A few but common from separate Polish manufacturers - sadly a few bigger ones were bought up by Valeant or Teva with concomitant price increase. They're pretty good, compared to random trash from India or China. They cannot match the volume, not even close, to be more than regional EU players.

paulsutter 7y ago

I would pay to see the book summarized in a “just the facts” format. Everything I can find is in a turgid storytelling format. For example: https://www.nytimes.com/2019/05/13/books/review/bottle-of-lies-katherine-eban.html https://www.nytimes.com/2019/05/13/books/review/bottle-of-li... The book itself is written in this same tedious style (first 56 pages available as a preview): https://books.google.com/books/about/Bottle_of_Lies.html?id=mGVzDwAAQBAJ&printsec=frontcover https://books.google.com/books/about/Bottle_of_Lies.html?id=...

oicu812 7y ago
I agree, even the audiobook was a chore to get through at 1.5x speed. However, it's not on GetAbstract yet: http://getabstract.com http://getabstract.com

jimbob45 7y ago

Well this is fascinating but the notes run out and I don't have three hours to listen to a podcast. Does anyone subscribe to this site that can share the notes?

ravar 7y ago
It's not a technical podcast so listening at 1.5 or 2x speed can really shorten the time demand with little lost information.
cliff 7y ago
It would be better to read the book she wrote, "Bottle of Lies". I highly recommend it.
- utopian3 7y ago
  I imagine that is longer than the 3-hour podcast
  - pfranz 7y ago
    Correct! Audible clocked in at 14 hrs and 26 mins

Paperweight 7y ago

Semi-related: Even though it's been 123 years since Cornflakes were patented, generic breakfast cereal just isn't the same. Some of them are downright revolting (e.g. mini-wheat knockoffs) even though they're made in the USA. Many don't even use the same ingredients. I guess their target market is people who don't care about quality? At all?

callmeal 7y ago
>I guess their target market is people who don't care about quality? At all? No, their target market is people who have no other choice. This is what regulatory capture gets you.
UnFleshedOne 7y ago
I thought "generic breakfast cereal" is "quick oats"?
r00fus 7y ago
There is no such thing as "generic" cereal because it has no guaranteed stock ingredients. You have a white-label producer, and many store-brands that simply slap a label on that white-label product. Obviously if the goal is to sell a product that's cheaper than the name-brand (Kellog's in this case), it's clear that's a race-to-the-bottom in terms of quality
jdietrich 7y ago
Processed foods are far more complex and involve far more technology than you might imagine. The production process used by the original manufacturer is effectively a black box, so cloning a breakfast cereal involves a major reverse-engineering effort. The thoroughness of that effort is bounded by the need to undercut the original manufacturer on price, which may also affect the quality of ingredients.
- derefr 7y ago
  > The production process used by the original manufacturer is effectively a black box Don't they patent that, too? Isn't that what the parent commentor is referring to when saying "it's been 123 years since Cornflakes were patented"—that the original manufacturer's exact factory design should be in the public domain by now?

shiftoutbox 7y ago

The fda knew aboutthis for years ; but it’s insanely hard to prove . Take Levothyroxine , a synthetic thyroid hormone brand names is Synthroid. Analogs ( generics ) sort of work but unless you abuse it it’s hard to tell if it working . Most of the time generic synthroid is as good as blue chalk . Then take insulin , no generic maker will attempt to make it; two reasons , if you fuckup insulin diabetics die . Secondly diabetics can rapidly tell if their insulin is good or not . It either lowers their blood sugar or it’s useless .

majos 7y ago

This is the second cautionary piece about generic drugs I’ve read in the past two days. The first was from last week’s Economist [1] and made a different point. It argued that generic drugs are such a viciously competitive market that the surviving manufacturers are those that cut the most corners. Corners cut range from outright fraud (as mentioned in this topic) to manufacture that is both highly consolidated and prone to just-rare-enough breakdowns that — because more reliable competitors have been priced out of the generics market — lead to sudden drastic shortages and the attendant problems for consumers. Zooming out a bit, it looks like a specific example of a wider trend of supply chains that are long and efficient until their fragility becomes clear thanks to a well-timed and well-placed break. I wonder what other specific products have a dysfunctional market like this? [1] https://www.economist.com/international/2019/09/14/a-dire-scarcity-of-drugs-is-worsening-in-part-because-they-are-so-cheap https://www.economist.com/international/2019/09/14/a-dire-sc...

User23 7y ago

More in the same vein from the always excellent Derek Lowe: https://blogs.sciencemag.org/pipeline/archives/2019/07/25/got-it-all-ready-for-you-mr-fda-inspector https://blogs.sciencemag.org/pipeline/archives/2019/07/25/go...

Scoundreller 7y ago
Anyone interested in this topic should read everything he’s ever written. The comments from anonymous insiders reminds me of HN.

TheOperator 7y ago

I remember being in the first wave of people where doctors noticed how generics were not working as well as the brand name drugs in a big way. Back when there was basically nothing in the news ever about generics not being as good as regular drugs and instead people were talking about how smart it was to buy generic. Generics are used to justify cutting insurance payments for the actual brand name medication. Years later after an investigation a decent chunk of generics actually went off the market because they were crap. This is a field that has faced unreasonably low levels of scrutiny historically. So it's no shock to see stories like this.