Dr_Dan
★★  

Germany,
2014-12-05 09:42
(3401 d 11:26 ago)

Posting: # 13981
Views: 20,856
 

 Bioequivalence in prime time TV news [BE/BA News]

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
nobody
nothing

2014-12-05 09:51
(3401 d 11:16 ago)

@ Dr_Dan
Posting: # 13982
Views: 19,217
 

 Bioequivalence in prime time TV news


Kindest regards, nobody
Ohlbe
★★★

France,
2014-12-05 15:10
(3401 d 05:57 ago)

@ nobody
Posting: # 13985
Views: 19,160
 

 Bioequivalence in prime time TV news

More details here.

Regards
Ohlbe
nobody
nothing

2014-12-05 17:56
(3401 d 03:12 ago)

@ Ohlbe
Posting: # 13987
Views: 19,193
 

 Bioequivalence in prime time TV news

btw: Who did the due diligence for Hexal etc. before buying that shit? :-D

Edit: better? :-D

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
Helmut
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Vienna, Austria,
2014-12-05 18:24
(3401 d 02:43 ago)

@ nobody
Posting: # 13988
Views: 19,204
 

 Bioequivalence in prime time TV news

Hi laconic Odysseus,

you get what you pay for. Ask Ms T-F. BTW, did you ever read the Forum’s Policy?

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2015-01-23 18:08
(3352 d 02:59 ago)

@ Ohlbe
Posting: # 14318
Views: 18,102
 

 Bioequivalence in prime time TV news


Kindest regards, nobody
Helmut
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Vienna, Austria,
2014-12-05 14:27
(3401 d 06:40 ago)

@ Dr_Dan
Posting: # 13984
Views: 19,372
 

 If you know German…

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.

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2014-12-05 15:20
(3401 d 05:48 ago)

@ Helmut
Posting: # 13986
Views: 19,217
 

 If you know German…

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
Helmut
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2014-12-05 18:49
(3401 d 02:18 ago)

@ nobody
Posting: # 13989
Views: 19,305
 

 Monitoring CROs

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.

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2014-12-05 19:02
(3401 d 02:05 ago)

@ Helmut
Posting: # 13990
Views: 19,193
 

 Monitoring CROs

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?

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Helmut
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2014-12-05 23:54
(3400 d 21:13 ago)

@ nobody
Posting: # 13992
Views: 19,358
 

 Ethics?

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.

During the ICF session it was noted that the volunteers were more concerned about the issue of payment than their health. The amount mentioned or agreed upon in the protocol document does not match the amount paid to the volun­teers. While the ethics committee laid down that the HVs are paid Rs 2500, the VMT [voluntary mobilisation team] coordinators promised Rs 5000, but the HVs demanded Rs 10,000. It was finally negotiated that the HVs would be paid Rs 8200 for seven days, in addition to allowance for travel, accommodation and food.



  • Krisha S, Prasad PN. Ethical issues in recruitment of “healthy volunteers”: study of a clinical research organisation in Hyderabad. Indian J Med Ethics. 2014;11(4):228–32. [image] free resource.

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2014-12-06 15:23
(3400 d 05:44 ago)

@ Helmut
Posting: # 13996
Views: 19,191
 

 Ethics?

hi!

[image]

Kindest regards, nobody
ElMaestro
★★★

Denmark,
2014-12-06 23:10
(3399 d 21:57 ago)

@ Helmut
Posting: # 13997
Views: 19,150
 

 Monitoring CROs

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.:-D Check out Robert Evans for comparison.

Pass or fail!
ElMaestro
Helmut
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Vienna, Austria,
2014-12-07 15:08
(3399 d 05:59 ago)

@ ElMaestro
Posting: # 13999
Views: 19,220
 

 Monitoring CROs

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.

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2014-12-12 11:51
(3394 d 09:17 ago)

@ Helmut
Posting: # 14062
Views: 19,047
 

 Monitoring CROs


Kindest regards, nobody
Helmut
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Vienna, Austria,
2014-12-12 15:41
(3394 d 05:26 ago)

@ nobody
Posting: # 14065
Views: 19,126
 

 Inspectors ≠ teachers (rather = examiners)

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 told US FDA that your goal and our goal is common: providing safe effec­tive and quality medicines to US citizens. How best can we do this? Can we work together?
“When a student in a classroom is lagging behind the onus is also on the teacher to help the student catch up with the rest of the class. This is the solution, not policing and filing 483s.”


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.
In the UK, an Act of Parliament, law, and guidelines on how to interpret it “are all compiled together and available in one book.”
“The US FDA only have an Act, and guidances are issued from time to time but there is no compilation available of those guidances.
“So there is a need for US FDA to put its documents in order.”


I beg your pardon? Never came across CDER’s guidances (not to speak of the 1208 [sic] product-specific guidances published so far)?
:google:


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.”


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ElMaestro
★★★

Denmark,
2014-12-07 02:06
(3399 d 19:02 ago)

@ Dr_Dan
Posting: # 13998
Views: 19,128
 

 RCA

Hi all,

assuming fraud has truly been committed at GVK Bio what would you think is the root cause?

Pass or fail!
ElMaestro
Helmut
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Vienna, Austria,
2014-12-07 15:41
(3399 d 05:27 ago)

@ ElMaestro
Posting: # 14001
Views: 19,217
 

 Speculations

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] 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.
The Ahmedabad success comes on the heels of regulatory joint inspection by FDA, ANSM (France), AGES (Austria) and WHO, of the GVK BIO Hyderabad facility. This inspection was the first joint inspection of a CRO by the four agencies. GVK BIO received zero 483s by FDA in this joint inspection.

Nothing was written down. Bad luck for the FDA. Ask ANSM for their report…

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.”

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nothing

2014-12-07 18:31
(3399 d 02:36 ago)

@ Helmut
Posting: # 14002
Views: 19,087
 

 Speculations

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
ElMaestro
★★★

Denmark,
2014-12-07 21:20
(3398 d 23:47 ago)

@ Helmut
Posting: # 14004
Views: 19,117
 

 Speculations

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
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