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A comment on The FDA buries evidence of fraud in medical trials. My students and I dug it up.

Re:The FDA buries evidence of fraud in medical trials. My st... by MichaelGG on Friday February 13, 2015 @03:27AM (#9043423)
A related and very interesting story is this article[1] on Ranbaxy. Basically this company was corrupt and fraudulent from the top down. Falsifying data, copying competitor information as their own, etc. Or encouraging internationally traveling employees to privately import medicines to India for them. Or asking doctors on staff to write prescriptions for everyone in the office to boost sales figures.

The FDA applied light bans, only on individual manufacturing sites, allowing the company to continue to push out product from other sites. Including making a bunch of pills with glass fragments in it.

The FDA eventually fined them $500M, and the company has since been bought by Sun Pharma, the largest in India. Zero indication that the systemic corruption, fraud, poor quality, etc. have had real change.

1: http://fortune.com/2013/05/15/dirty-medicine/

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Re:The FDA buries evidence of fraud in medical trials. My st... by hga on Friday February 13, 2015 @08:19AM (#9044134)
A bit more happened, last year the FDA started making unannounced visits to their production plants in India. When I checked on this about a month ago, it appeared that every Ranbaxy plant in India had been shut down. This Google search will provide a lot of info, https://www.google.com/search?q=Ranbaxy+flies that's "flies" as in those disease spreading insects. One of the articles had a picture of a man unloading dung from a cart with a Ranbaxy plant in the not too distant background....

I pay attention to this because I take a lifesaving maintenance medicine that my medical plan currently sources from Sun :-(. Since that and another important drug I take went generic over the last few years, my doctor has been very happy with my reporting that to me, they seem to be bioequivalent. He's in a field when generics of one class of drugs, the anti-convulsants, are notorious for not being easily substituteble with brand name.

Ah, a bit more on that fabulous Fortune article: their First World drug mules were being asked to deliver First World brand name manufactured drugs so that Ranbaxy could falsify equivalence tests. One US executive left the company after the 2nd "wow, these guys are so good their data matches the brand names's point to point" "coincidence".

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Re:The FDA buries evidence of fraud in medical trials. My st... by refurb on Friday February 13, 2015 @11:11AM (#9045032)
When I checked on this about a month ago, it appeared that every Ranbaxy plant in India had been shut down.

I'm not sure if they are shutdown, but the FDA has banned imports into the US from everyone of the Ranbaxy plants. Sun Pharma is in a bad situation with this since they can't sell into the US market from their new acquisition.

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Re:The FDA buries evidence of fraud in medical trials. My st... by hga on Friday February 13, 2015 @12:05PM (#9045349)
Initially they of course didn't shut down, that's not in Ranbaxy's DNA, but other parts of the world were none too pleased with the horrendous details of the FDA inspections, and that forced the shutdown of every one of their Indian plants at their 4 major locations.

As for Sun, who knows? In 2008 Ranbaxy managed to pawn off 64% of the company to Japan's Daiichi-Sankyo for $7 billion. Sun bought that stake in 2014 for $4 billion ... in Sun shares, i.e. a firesale price, at least compared to the original. And Ranbaxy has lots of plants outside India which to my knowledge and recent research can still ship to the US.

Although I'm not sure how many of those actually synthesize the raw stuff as these Indian plants did, then again Sun is probably best off with them shut down; that they didn't proactively deal with the Ranbaxy's cancer ... well, you can see why I'm nervous about that drug I'm taking.

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Re:The FDA buries evidence of fraud in medical trials. My st... by MichaelGG on Friday February 13, 2015 @02:27PM (#9046601)
Wow, that's fantastic and unexpected news. Is the FDA doing surprise inspections all over? Like, Sun buying them, then letting things stay bad, pretty much indicates they rather complicit. Or is it thought they wanted a "dirty" division to try tricks in, while keeping an otherwise clean company?
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Re:The FDA buries evidence of fraud in medical trials. My st... by g_mifo on Sunday February 15, 2015 @12:22AM (#9051848)
Thank you for your inspirational efforts to take control of the quality of your medication. Patients need to empower themselves to become experts in their condition and treatment.
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Re:The FDA buries evidence of fraud in medical trials. My st... by benrapscallion on Friday February 13, 2015 @10:12AM (#9044684)
Importantly, in the meantime the original promoters Shivinder Singh and Malvinder Singh quickly sold the company to Daiichi Sankyo to wash their hands off the mess that they had created.
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Re:The FDA buries evidence of fraud in medical trials. My st... by hga on Friday February 13, 2015 @12:13PM (#9045403)
Sort of, that sale was back in 2008 and they retained a 36% stake (see my other recent comment for the sale to Sun Pharma). But they of course knew their company was a fraud, as the Fortune article makes clear.

Let me put in a word for Indian English: the usage of "promoters" for that class of businessmen is perfect.

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