Helmut ★★★ Vienna, Austria, 2013-04-17 18:53 (4253 d 23:17 ago) Posting: # 10429 Views: 13,392 |
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Hi all, last week a former member of EMA’s Biostatistics Working Party recommended to me some scary stuff: Ben Goldacre — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
The Outlaw Torn ★ Europe, 2013-04-22 09:41 (4249 d 08:29 ago) @ Helmut Posting: # 10446 Views: 11,726 |
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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 ★★★ Vienna, Austria, 2013-04-22 16:05 (4249 d 02:06 ago) @ The Outlaw Torn Posting: # 10457 Views: 11,713 |
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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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
The Outlaw Torn ★ Europe, 2013-04-23 10:32 (4248 d 07:38 ago) @ Helmut Posting: # 10469 Views: 11,725 |
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On a similar note, have you read this one: Scientific malfeasance |
Helmut ★★★ Vienna, Austria, 2013-05-31 19:17 (4209 d 22:54 ago) @ The Outlaw Torn Posting: # 10704 Views: 12,116 |
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Hi Outlaw! ❝ […] Scientific malfeasance Fantastic. 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 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.« Makes me sick. BTW, in 2008 these guys cashed $2 billion by selling their 34% stake to Daiichi Sankyo. Enough for each of them to buy a Ferrari 458 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? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
The Outlaw Torn ★ Europe, 2013-06-06 09:40 (4204 d 08:30 ago) @ Helmut Posting: # 10735 Views: 11,403 |
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And no one went to jail for any of this! Unfreakingbelievable! |
Helmut ★★★ Vienna, Austria, 2013-06-08 23:29 (4201 d 18:41 ago) @ The Outlaw Torn Posting: # 10756 Views: 11,333 |
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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 hope. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ohlbe ★★★ France, 2013-06-09 00:38 (4201 d 17:32 ago) @ Helmut Posting: # 10757 Views: 11,440 |
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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... I hope their GMP inspectors know better... — Regards Ohlbe |
ElMaestro ★★★ Denmark, 2013-06-09 01:09 (4201 d 17:02 ago) @ Ohlbe Posting: # 10758 Views: 11,362 |
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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. — Pass or fail! ElMaestro |
Helmut ★★★ Vienna, Austria, 2013-08-26 16:57 (4123 d 01:13 ago) @ Ohlbe Posting: # 11346 Views: 10,820 |
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Hi Ohlbe et al., seems to develop into a never-ending story. See this recent article: 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? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |