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Dr_Dan ★★ Germany, 2014-12-05 09:42 (3808 d 13:03 ago) Posting: # 13981 Views: 22,989 |
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Dear all Yesterday evening one of the head lines in Germany most popular TV news: Fraud at GVK Bio! Hundred of bioequivalence studies faked and the generic industry in big trouble. We will see what happens.... Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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nobody nothing 2014-12-05 09:51 (3808 d 12:54 ago) @ Dr_Dan Posting: # 13982 Views: 20,998 |
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— Kindest regards, nobody |
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Ohlbe ★★★ France, 2014-12-05 15:10 (3808 d 07:35 ago) @ nobody Posting: # 13985 Views: 20,977 |
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More details here. — Regards Ohlbe |
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nobody nothing 2014-12-05 17:56 (3808 d 04:49 ago) @ Ohlbe Posting: # 13987 Views: 20,979 |
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btw: Who did the due diligence for Hexal etc. before buying that shit?  Edit: better? What I think would be interesting: Did you need an audit to see it's fake or could you see it from an in-depth analysis of the report? — Kindest regards, nobody |
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Helmut ★★★   Vienna, Austria, 2014-12-05 18:24 (3808 d 04:21 ago) @ nobody Posting: # 13988 Views: 21,008 |
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Hi laconic Odysseus, you get what you pay for. Ask Ms T-F. BTW, did you ever read the Forum’s Policy? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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nobody nothing 2015-01-23 18:08 (3759 d 04:37 ago) @ Ohlbe Posting: # 14318 Views: 19,912 |
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Hi both! Story unfolding: https://www.ema.europa.eu/en/news/gvk-biosciences-european-medicines-agency-recommends-suspending-medicines-over-flawed-studies ...tacrolimus... hmmm--- — Kindest regards, nobody |
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Helmut ★★★ Vienna, Austria, 2014-12-05 14:27 (3808 d 08:18 ago) @ Dr_Dan Posting: # 13984 Views: 21,152 |
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Hi Dan, ❝ Yesterday evening one of the head lines in Germany most popular TV news: Fraud at GVK Bio! https://www.tagesschau.de/multimedia/video/video-45457.html https://www.tagesschau.de/inland/verkaufsstopp-medikamente-101.html Any particular reasons why you posted in this category? I changed it to BA/BE News. — 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 |
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nobody nothing 2014-12-05 15:20 (3808 d 07:25 ago) @ Helmut Posting: # 13986 Views: 21,008 |
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Sandbox? Wow, that's pretty cool 8-D ...the intereting question might be: How could they keep it out of the public for so long? Typical example for agenda setting... — Kindest regards, nobody |
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Helmut ★★★ Vienna, Austria, 2014-12-05 18:49 (3808 d 03:55 ago) @ nobody Posting: # 13989 Views: 21,120 |
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Hi nobody, ❝ ...the intereting question might be: How could they keep it out of the public for so long? Who do you mean by “they”? IMHO sponsors should monitor CROs. If they didn’t find the falsified ECGs (unlike the French inspector) that would be a sign of incompetence. — 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 |
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nobody nothing 2014-12-05 19:02 (3808 d 03:42 ago) @ Helmut Posting: # 13990 Views: 21,039 |
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Hi! "they"? I leave it to you to figure out why this has been known since summer but never popped up somewhere in the mainstream media. Is it "only" about ECG data or is there more? I didn't follow this case closely. I remember one CRO in the Ranbaxy case, but is there some kind of overview on notorious CRO for such stuff? — Kindest regards, nobody |
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Helmut ★★★ Vienna, Austria, 2014-12-05 23:54 (3807 d 22:51 ago) @ nobody Posting: # 13992 Views: 21,177 |
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Hi nobody, ❝ Is it "only" about ECG data or is there more? I didn't follow this case closely. Yep. I can send you sumfink. ❝ I remember one CRO in the Ranbaxy case, but is there some kind of overview on notorious CRO for such stuff? Not that I recall. BTW, some European member states started to suspend MAs; the BfArM is one of them (#1, #2). Ethics? C’mon!* None of the 50 HVs [Healthy Volunteers] knew anything about the study in which they were participating. It was surprising that even the volunteers who were graduates did not remember any of the details of the trial (the name or purpose of the study). They only remembered that blood would be drawn from them, that they may develop rashes or a headache, and that they should report any other symptoms that crop up. They were quite confident that the doctors and the facilities available would suffice to deal with any health risk they might encounter in the course of the trial. Several HVs said that participating in these studies was like an alternative profession for them.
— 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 |
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nobody nothing 2014-12-06 15:23 (3807 d 07:22 ago) @ Helmut Posting: # 13996 Views: 20,996 |
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hi! ![[image]](http://www.greensmilies.com/smile/smiley_emoticons_papiertuete-kopf.gif) — Kindest regards, nobody |
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ElMaestro ★★★ Denmark, 2014-12-06 23:10 (3806 d 23:35 ago) @ Helmut Posting: # 13997 Views: 20,955 |
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Hi Hötzi, ❝ Who do you mean by “they”? IMHO sponsors should monitor CROs. If they didn’t find the falsified ECGs (unlike the French inspector) that would be a sign of incompetence. Thanks for sharing your endless wisdom.  I think there are nuances here. As a private auditor you cannot write you have detected fraud. You will end up with a bunch of lawyers fees to pay. Writing that you see conduct which may not be fully compatible with the principles of GCP blah blah is what most have to resort to. Second, actually realising fraud is present is not always completely easy. Let me show you, say, 10 ECGs of which 3 come from the same person sampled 2 minutes apart. Do you think you would see it? If you answer yes then your popularity might be sharply increasing over the next year or so. Check out Robert Evans for comparison.— Pass or fail! ElMaestro |
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Helmut ★★★ Vienna, Austria, 2014-12-07 15:08 (3806 d 07:37 ago) @ ElMaestro Posting: # 13999 Views: 21,025 |
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Hi ElMaestro, ❝ As a private auditor you cannot write you have detected fraud. Why not? The sponsor should be happy that I detected it and not an inspector years later. I had three cases in my career (stupid mistakes – not fraud). The studies were repeated. In two cases CROs repeated studies for free and in one the net costs where shared 50/50 (because the sponsor could have detected the mistake during his monitoring; I discovered a mistake in the randomization after the study was completed). ❝ You will end up with a bunch of lawyers fees to pay. Why? ❝ Writing that you see conduct which may not be fully compatible with the principles of GCP blah blah is what most have to resort to. Why? ❝ Second, actually realising fraud is present is not always completely easy. Let me show you, say, 10 ECGs of which 3 come from the same person sampled 2 minutes apart. Do you think you would see it? No way. But: I have heard about ECGs where in the PDFs the subject-ID was edited in Acrobat. Stupidly the edited ID was in Arial and everything else in Courier. I guess I would be able to see this. ❝ If you answer yes … I don’t – though I have some sympathies for idiot savants. — 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 |
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nobody nothing 2014-12-12 11:51 (3801 d 10:54 ago) @ Helmut Posting: # 14062 Views: 20,859 |
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Hi, ready for some really cool stuff? Here we go https://www.in-pharmatechnologist.com/Article/2014/12/11/IPA-says-bad-inspectors-making-Indian-manufacturers-fear-visits — Kindest regards, nobody |
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Helmut ★★★ Vienna, Austria, 2014-12-12 15:41 (3801 d 07:04 ago) @ nobody Posting: # 14065 Views: 20,943 |
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Hi nobody, THX for sharing; bizarre reading. [Dilip] Shah [Secretary General of the Indian Pharmaceutical Alliance] said the FDA should take a less aggressive and more helpful attitude to teach [sic] manufacturers how to meet its standards. I would say it’s not the job of inspectors to teach companies the rules of GxP – established for decades. Being willing to read helps a lot. Courses are available everywhere. Ignorance is no excuse. To stay with the school-analogy: Inspectors are examiners, not teachers. When you take an exam you should have mastered the assessment load – unless you hope for sheer chance or “passing by cheating”. IPA’s Secretary General also criticised what he called a lack of guidance for manufacturers on how to implement US laws. I beg your pardon? Never came across CDER’s guidances (not to speak of the 1208 [sic] product-specific guidances published so far)?  PS: https://www.in-pharmatechnologist.com/Article/2014/12/09/CPHI-India-experts-say-data-fraud-dragging-down-Indian-manufacturing Ajit Dangi, Chairman of Fulford India, a Merck % Co.subsidiary, claimed to have seen statistics showing “in life sciences, almost 35% of the bio data are embellished – I’m using a very polite word. If that’s the case, you know the culture has a problem and that’s why data integrity and GMP go hand in hand.” — 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 |
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ElMaestro ★★★ Denmark, 2014-12-07 02:06 (3806 d 20:39 ago) @ Dr_Dan Posting: # 13998 Views: 20,916 |
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Hi all, assuming fraud has truly been committed at GVK Bio what would you think is the root cause? — Pass or fail! ElMaestro |
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Helmut ★★★ Vienna, Austria, 2014-12-07 15:41 (3806 d 07:04 ago) @ ElMaestro Posting: # 14001 Views: 21,015 |
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Hi ElMaestro, ❝ assuming fraud has truly been committed at GVK Bio what would you think is the root cause? Duno. Greed? Though saving a few rupees seems to be outright absurd. These ECGs were part of the post study exams. Did they want to avoid complications – what if an ECG shows abnormalities? Hey, that’s a normal one – let’s use it for other volunteers! GVK claimed that these ECGs do not invalidate the outcome of BE-studies. But that’s not the point. It shows non-compliance with the principles of GCP – which casts a dim light on other parts of the studies as well. Remember the credo of GxP-inspectors “if you didn’t write it down, you didn’t do it”. Fraudsters have learned this lesson. GVK proudly stated on their ![[image]](https://forum.bebac.at/img/uploaded/IAsmall.png) website:GVK Biosciences, Asia’s leading Contract Research Organization today announced that its Ahmedabad Clinical Pharmacology Unit successfully cleared the US FDA Audit with zero 483s/ observations from the agency. Henning Blume was once invited by an Indian CRO. He asked how many studies failed in the past. The answer was “zero”. He replied “That’s an amazing percentage. Probably you should teach us how to design and perform BE-studies. Our failure rate is much higher.” — 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 |
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nobody nothing 2014-12-07 18:31 (3806 d 04:14 ago) @ Helmut Posting: # 14002 Views: 20,887 |
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What is the producer risk (rough estimate is sufficient) for a BE-study? Just asking... Sometimes statistics is against you, sometimes it's your friend. Not to speak of being able to read chromatograms, calibration curves etc. I would start with an overview on all analytical runs performed, from validation to the final study samples. Dates, times, run time per chromatogram, run time per batch. Compare to times on print-outs of chromatograms. Start from the basics (if we talk of the analytical part, clinics is a differnt piece of cake). If you can't get these data, reject the study overall. My 5cent... — Kindest regards, nobody |
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ElMaestro ★★★ Denmark, 2014-12-07 21:20 (3806 d 01:25 ago) @ Helmut Posting: # 14004 Views: 20,917 |
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Hi Hötzi, ❝ Duno. Greed? Greed is a cause, yes. I think some CROs know that vendor oversight is very relaxed among EU-based dossier developers and generic companies. The coverage is not very good. Only rarely do they in fact audit properly prior to studies and almost never afterwards. Much of the so-called audits are visit from business development people or other people who don't really look in depth at the QMS yet call it an audit still. I believe CROs know the game well. So in a sense I think GVK Bio were unlucky, they were detected against the odds. I wonder what else is out there. — Pass or fail! ElMaestro |
Ing. Helmut Schütz