Helmut
★★★
avatar
Homepage
Vienna, Austria,
2016-04-24 13:14

Posting: # 16232
Views: 16,099
 

 Fraud [BE/BA News]

Dear all,

will it ever end?
  1. FDA: Semler Research Ltd. (Bangalore)
    Samples substituted or diluted. Stupid enough to keep a spreadsheet documenting the manipulation on the server. The CRO responded that “[we] could not determine who created the document or its impact on the study endpoints […]”.
    Anything mentioned on the website? Nada.
  2. EMA: Alkem Laboratories Ltd. (Taloja)
    Copied ECGs following in GVK’s footsteps two years ago.
Lack of education? Interesting article in The Washington Post:
How bad are most of India’s medical schools? Very, according to new reports.

There are more medical colleges and teaching hospitals in India than anywhere else – 579 to be exact.
But a couple of recent studies and reports have cast serious doubts on the quality and ethics of the country’s vast medical schooling system. The most recent revealed that more than half of those 579 didn’t produce a single [sic] peer-reviewed research paper in over a decade (2005–2014), and that almost half of all papers were attributed to just 25 of those institutions.


Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
Ohlbe
★★★

France,
2016-04-24 23:42

@ Helmut
Posting: # 16233
Views: 14,927
 

 Fraud

Dear Helmut,

» Semler Research Ltd. (Bangalore)

The WHO also sent them a Notice of Concern.

An interesting paper in this context.

Regards
Ohlbe
Shuanghe
★    

Spain,
2016-04-25 10:10

@ Helmut
Posting: # 16234
Views: 14,802
 

 Fraud

Hi all,

» Samples substituted or diluted. Stupid enough to keep a spreadsheet documenting the manipulation on the server. ......

In a weird sense of data integrity concept, they did it quite well. How many CROs you guys know that documented all their manipulations nicely and orderly and put it out on their server (so somebody can find it later and trace the source of manipulation)? :-D

Now seriously: One subsidiary of our group in USA had done many studies in that CRO and FDA requested them, a couple of days ago, to repeat all studies in their ANDAs in another CRO. The worse thing is, they still got many studies from the same CRO that have not been submitted yet. So they are seriously screwed.

Fortunately we don't use the same CRO and I only know Semler from the bad news they told us last week. So my question is, what can sponsors do to avoid this kind of unfortunate situation? All studies have been monitored but obviously monitors didn't find anything. It seem every time when there's major screw-up the one to find them are almost always regulatory agencies.

All the best,
Shuanghe
Dr_Dan
★★  

2016-04-25 10:26

@ Shuanghe
Posting: # 16235
Views: 14,794
 

 Fraud

Hi all,
The sponsor gets what he expects: a bioequivalent study result. :-D
However, I guess in most cases the sponsor was not even involved in fraud. As long as CROs promise to only deliver bioequivalent studies this will not change. I think in India there need to be established a new and complete different way of thinking about the role of a CRO and its responsibility for public health. It is not just business.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
Relaxation
★    

Germany,
2016-04-29 11:45

@ Dr_Dan
Posting: # 16258
Views: 14,429
 

 Fraud

» The sponsor gets what he expects: a bioequivalent study result. :-D
» ...As long as CROs promise to only deliver bioequivalent studies this will not change.

I would add: As long as sponsors are willing to appoint CROs that give such statements (OK, and because they are cheap(er) ;-)), this will not change.

And all the best wishes,

Relaxation
nobody
nothing

2016-04-25 10:56
(edited by nobody on 2016-04-25 17:23)

@ Shuanghe
Posting: # 16236
Views: 14,779
 

 Fraud

Hi ladies, long time no see, busy weeks... :-)

» ... It seem every time when there's major screw-up the one to find them are almost always regulatory agencies.

Whistleblowers? At least in some cases, I guess.

Maybe lazy review in cases not found by clinical monitors or based on the final reports...

There has been fraud all over this world for the last couple of millennia, I guess. Keep an eye on the road ;-)




PS: I know I'm getting old, but why does it have to be printed in light grey (!) under my nick? :-D


Edit: Ask the guy who set up the forum’s CSS. Shall I change it to pink? ;-) You belong to the exclusive club (nine members) with 100–500 posts…

Kindest regards, nobody
nobody
nothing

2016-04-27 17:00

@ nobody
Posting: # 16252
Views: 14,577
 

 Fraud

» Shall I change it to pink? ;-)

...pink would be great! (sorry for OT post, but I couldn't edit my last post any more ;-))

Kindest regards, nobody
M.Vasu
★    

India,
2016-04-28 14:30

@ nobody
Posting: # 16256
Views: 14,530
 

 Fraud

Hi All,

Is it mandatory to monitor bioanalytical phase also by sponsor monitor? kindly share if any applicable guidelines.

Tnq
VM
nobody
nothing

2016-04-28 14:36

@ M.Vasu
Posting: # 16257
Views: 14,519
 

 Fraud

Hi!

Using the grey matter between your ears is not regulated by law or any kind of guideline. You simply do it, just as standing up in the morning or going to sleep at night…

Kindest regards, nobody
Ohlbe
★★★

France,
2016-04-29 14:01

@ Helmut
Posting: # 16260
Views: 14,425
 

 Fraud

Dear Helmut,

» FDA: Semler Research Ltd. (Bangalore)

EMA follows and has triggered an Article 31 referral.

Regards
Ohlbe
Mahesh M
★    

India,
2016-06-08 06:07
(edited by Ohlbe on 2016-06-08 11:00)

@ Helmut
Posting: # 16413
Views: 13,442
 

 Fraud

Dear All,

FYIP Alkem's Taloja facility gets clean chit by UK health regulator

Regards
Mahesh


Edit: link corrected [Ohlbe]
Ohlbe
★★★

France,
2016-06-08 11:58

@ Mahesh M
Posting: # 16416
Views: 13,378
 

 Fraud

Dear Mahesh,

» Alkem's Taloja facility gets clean chit by UK health regulator

The health regulator has reviewed the corrective and preventive actions submitted by the company and has considered them acceptable

Meaning that the company has taken adequate measures and that they are now considered to be OK, but not that nothing happened in the past. We'll see the outcome of the Article 31 referral, normally at the end of this month.

Regards
Ohlbe
Ohlbe
★★★

France,
2016-07-04 11:04

@ Helmut
Posting: # 16465
Views: 12,918
 

 One more

Dear all,

Next on the list: Quest Life Sciences.

"The MHRA inspectors identified a large number of issues which indicated that there were very serious concerns with many aspects of the company's quality system," the MHRA spokesman said, adding the problems cast "serious doubt on the integrity of any data produced."

The same site had received a Notice of concern from the WHO last year. The usual routine: 67 % of the ECGs were duplicate from each others, and the WHO inspector caught them red-handed making up documents during the inspection.

Regards
Ohlbe
ElMaestro
★★★

Belgium?,
2016-07-22 15:06

@ Helmut
Posting: # 16515
Views: 12,284
 

 Fraud


I could be wrong, but...
Best regards,
ElMaestro
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2018-02-14 14:20

@ ElMaestro
Posting: # 18417
Views: 8,670
 

 Kill the messenger

Dear all,

outright bizarre.

‘Ostracized and criticized’ Indian CRO hits US FDA with $50m lawsuit
29-Jan-2018 by Dan Stanton

Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns.

[…] Semler filed a lawsuit against the FDA, the United States Department Of Health And Human Services (HHS) and the United States Of America – along with various individuals – for total damages of approximately $50m (€40m).
The firm claims the FDA’s actions were in violation of the Fifth Amendment, interfered with economic advantages and intentionally inflicted financial distress on the company.
They left Semler with a stigma leading to “the complete annihilation of SRC’s business and its exposure to monetary claims from its customers,” the firm said in its complaint logged with the United States District Court Central District of California.
Among the accusations, Semler said the respondents “failed to conduct a proper and reasonable investigation under the circumstances to avoid making baseless and unsupported conclusions regarding SRC’s Clinical and BA/BE studies,” and failed to conduct its investigation “in a reasonable and prudent manner.”
The plaintiff claims the defendants did this with the “intent of eliminating SRC from the marketplace to the benefit of other CROs,” especially those based in the US and those based in India “with whom FDA Inspectors had personal relationship with the owners or employees.”


Can You Sue FDA for Negative Audit Findings? Indian Company Tests US Legal System
FDAMap, February 1, 2018

[…] In their lawsuit, the company specifically identified all the inspectors who visited its facilities in India for the fateful audit, and their supervisors in the FDA offices in Maryland. First, Semler claims that a rogue employee working in concert with former disgruntled employees intentionally placed a defective spreadsheet on its servers and then pointed FDA inspectors to it. Second, Semler claims that the FDA inspectors had a conflict of interest in their “personal relationship” with competing CROs and acted with the intent to “eliminate” Semler from competition. Third, Semler states that the inspectors did not follow due process. While errors were found in a few studies conducted by the company, FDA extrapolated the findings to all studies conducted by Semler, even those that had previously been audited and cleared by FDA, hence the lack of due process. The company does not deny the accuracy of the findings by FDA inspectors. It also does not justify how its data systems could be breached by one rogue employee or why it could not clarify the errors pointed by FDA inspectors. […] It should be noted that Semler had been audited and cleared by FDA multiple times before. So, a case can be made that if FDA inspectors were incompetent previous times.


View Case No.: 2:18-CV-00534 filed 01/22/18 in all its beauty:

PLAINTIFF SEMLER RESEARCH CENTER PRIVATE LIMITED’S COMPLAINT FOR DAMAGES


Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
nobody
nothing

2018-02-14 16:56

@ Helmut
Posting: # 18418
Views: 8,551
 

 Kill the messenger

...as of February 2018 I have become very reluctant with the use of the word "bizarre", but my first thought on reading this some days ago was: Interesting twist for an already outstanding plot!

Maybe we can have something with some native American tribes, patents, porn actors, shush money etc pp. in the second season of "India and FDA"...

Has Amazon or Apple bought the rights for the movie version?

Kindest regards, nobody
jag009
★★★

NJ,
2018-02-14 19:51

@ Helmut
Posting: # 18419
Views: 8,581
 

 Kill the messenger

Of course you can sue! :rotfl:
Heck if a robber can sue you for roughing him up during an attempted robbery (a true story, don't remember the outcome), anything goes!

J
Ohlbe
★★★

France,
2018-02-15 01:28

@ Helmut
Posting: # 18420
Views: 8,536
 

 Kill the messenger

Dear Helmut,

» View Case No.: 2:18-CV-00534 filed 01/22/18 in all its beauty:
»    PLAINTIFF SEMLER RESEARCH CENTER PRIVATE LIMITED’S COMPLAINT FOR DAMAGES

I had read the papers, but not the complaint. Thanks for the link.

I was not aware that conspiracy theory was admissible as evidence in court...

Regards
Ohlbe
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