Helmut
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Vienna, Austria,
2013-04-17 16:53

Posting: # 10429
Views: 10,298
 

 Recommended reader [Off Topic]

Hi all,

last week a former member of EMA’s Biostatistics Working Party recommended to me some scary stuff:

Ben Goldacre
Bad Pharma™
How drug companies mislead doctors and harm patients
HarperCollins, London, UK, 2012
ISBN 978-00-00-735074-2

See also the article in Wikipedia.

Cheers,
Helmut Schütz
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The Outlaw Torn
★    

Europe,
2013-04-22 07:41

@ Helmut
Posting: # 10446
Views: 9,235
 

 Recommended reader

I've seen this recommendation put forth now from multiple sources. This one may be the one that makes me do something about it. Thanks, Helmut.

The Outlaw.
Helmut
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Vienna, Austria,
2013-04-22 14:05

@ The Outlaw Torn
Posting: # 10457
Views: 9,266
 

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Hi Outlaw,

keep in mind that Mr Goldacre writes for laypersons. If you want you can skip the first parts and head directly for Chapter 4… Ugly.

Cheers,
Helmut Schütz
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The Outlaw Torn
★    

Europe,
2013-04-23 08:32

@ Helmut
Posting: # 10469
Views: 9,221
 

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On a similar note, have you read this one: Scientific malfeasance
Helmut
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Vienna, Austria,
2013-05-31 17:17

@ The Outlaw Torn
Posting: # 10704
Views: 9,341
 

 BE without fail? R vs. R! Become a billion­aire!

Hi Outlaw!

» […] Scientific malfeasance

Fantastic.

[image]Now get a decent cup of tea, sit down, read this story and the follow up. Details given by the US Department of Justice and :blahblah: [image] archived from Ranbaxy’s website.

   »Company scientists told Thakur’s staff that they were directed to […] substitute brand-name drugs in lieu of their own ge­nerics in bio­equi­va­lence tests to produce better results.«
   »And then there was the ultimate shortcut: using brand-name drugs as stand-ins for its own in bioequivalence studies.«
   »Ranbaxy executives didn’t care, says Kathy Spreen, and made little effort to conceal it. In a con­ference call with a dozen company executives, one brushed aside her fears about the quality of the AIDS medicine Ranbaxy was supplying for Africa. “Who cares?” he said, according to Spreen. “It’s just blacks dying.”«


Makes me sick. :vomit:

BTW, in 2008 these guys cashed $2 billion by selling their 34% stake to Daiichi Sankyo. Enough for each of them to buy Ferrari 458 Spiders every single week for the rest of their lives!
Given their chutzpah, I’m sure they would succeed in negotiating a discount.


Edit: In 2014–2015 Daiichi Sankyo gave up sorting out this mess (seemingly to accept an $800 million loss was considered cheaper than to continue) and sold to Sun Pharma making it the largest Indian pharma company and the 5th largest generic company worldwide. Do you think that Sun can/will do better than the Japanese?

Cheers,
Helmut Schütz
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The Outlaw Torn
★    

Europe,
2013-06-06 07:40

@ Helmut
Posting: # 10735
Views: 8,913
 

 BE without fail? R vs. R! Become a bil­lion­aire!

And no one went to jail for any of this! Unfreakingbelievable!
Helmut
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Vienna, Austria,
2013-06-08 21:29

@ The Outlaw Torn
Posting: # 10756
Views: 8,880
 

 BE without fail? R vs. R! Become a billionaire!

Hi Outlaw,

strong statement:

All Ranbaxy products currently in the Indian market and globally are safe and efficacious. Ranbaxy stands by the quality of every medicine that the company makes and distributes in India and every country in the world.”


Safety and efficacy proven by “bioequivalence” studies of the TT|RR-type? Or was it just RR? Can one of the forum’s seven members registered with a Ranbaxy e-mail address / IP please clarify my doubts?

» And no one went to jail for any of this!

Not yet. There is [image] hope.

Cheers,
Helmut Schütz
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Ohlbe
★★★

France,
2013-06-08 22:38

@ Helmut
Posting: # 10757
Views: 8,878
 

 BE without fail? R vs. R! Become a bil­lion­aire!

Hi Helmut,

It looks like either the Indian Minister of Health had access to alternate sources of information, or he doesn't understand what he's talking about:

In the production of the medicines, the company may have forgotten to follow one or two steps prescribed by the US FDA...
:lamer:


I hope their GMP inspectors know better...

Regards
Ohlbe
ElMaestro
★★★

Denmark,
2013-06-08 23:09

@ Ohlbe
Posting: # 10758
Views: 8,858
 

 BE without fail? R vs. R! Become a billionaire!

Oh,

» In the production of the medicines, the company may have forgotten to follow one or two steps prescribed by the US FDA...

Holy currrrap! I think I need a double dose of schützomycin tonight.

if (3) 4

x=c("Foo", "Bar")
b=data.frame(x)
typeof(b[,1]) ##aha, integer?
b[,1]+1 ##then let me add 1


Best regards,
ElMaestro

“(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures.” New York Times (ed.), June 9, 2018.
Helmut
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Vienna, Austria,
2013-08-26 14:57

@ Ohlbe
Posting: # 11346
Views: 8,334
 

 BE without fail? R vs. R! Become a billionaire!

Hi Ohlbe et al.,

seems to develop into a never-ending story. See this recent article:

[image] FDA Data Integrity Concerns Continue in India as Three More Firms Draw GMP Warning Letters



PS: IMHO, it is more than telling that none of the ~700 (‼) Indian members of the forum considered it worth the trouble participating in this thread. :-(
Silence is Golden?

Cheers,
Helmut Schütz
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