[Ip-health] Cancerous Data? Novartis Statistics Whiz Blows The Whistle On Data Reporting System

[Joana Ramos]

FYI, from today's Pharmalot blog, abt. data on Tasigna trials. If you go
to original article you can link out to copy of lawsuit documents, as
well as NVS press release announcing FDA's 3-month delay in approving
Tasigna .

Joana

---------------------------------

http://www.pharmalot.com/2007/07/cancerous-data-novartis-stats-whiz-blows-w=
histle/#more-8514

Cancerous Data? Novartis Statistics Whiz Blows The Whistle On Data
Reporting System
July 19th, 2007 6:36 pm By Ed Silverman


As David Olagunju tells it, he enjoyed his work at Novartis, where he
was global director of biostatistics and statistical reporting
standards, until early last year. That=92s when he was shifted to the
oncology division, and was soon reporting to a new supervisor. The rest
of 2006, he says, was filled with nothing but anxiety. In fact, by this
past January, he was out of a job.

Why? In a lawsuit filed in May in a New Jersey state court, the
59-year-old Nigerian native alleges he uncovered numerous violations of
the drugmaker=92s safety reporting system, which is used to process safety
data from clinical trials, in particular the Tasigna cancer med trials.
He reported the problems internally, but claims to have suffered only
retaliation, such as negative performance reports. A Novartis
spokeswoman declined to comment. Here=92s the lawsuit.

Since then, Olagunju says he met last month with FDA inspectors and gave
them documents - protocols, statistical analyses, e-mails - to support
his claims. An FDA spokeswoman would only say the agency =93doesn=92t have
any information to provide.=94 Olagunju, however, is asking the FDA to
audit the Tasigna trials. Coincidentally, Novartis disclosed this week
that Tasigna approval was delayed three months while the FDA reviews
additional data; no new studies were required.

Among the allegations: The reporting system wasn=92t validated according
to regulatory standards and generated errors - empty files, poor
documentation=85.

=85.incorrect date imputation for adverse events, wrong variables, and
mismatched items. In fact, Olagunju says the problems surfaced in 2004,
but worsened in early 2006, prompting him to complain. Ultimately, he
adds, this allegedy broken system was used to crunch data for 148
different clinical trials.

Another example: a contract programmer complained of being forced to
alter the calculation of the duration of adverse events to enhance the
appearance of Tasigna=92s safety in clinical trials. Then, the Development
Leadership Team, which is a group of vice presidents, allegedly
redefined the details of how patients were randomly assigned to
treatment drugs, and how the effect of the drugs were measured, reported
statistically and negotiated with the FDA a few days prior to locking
the data base.

The bottom line: =93By compressing the duration of adverse effects,
Novartis has exposed the public to a serious danger if this drug were to
be approved=85These issues have serious impact on the reporting of safety
data and have negative impact all of Novartis=92 clinical trials, not just
the clinical trials for Tasigna,=94 according to the lawsuit. Again,
however, these are only allegations and the FDA isn=92t saying anything
one way or the other.

=93I followed the company=92s policy of reporting such problems to the
letter. I went step by step. But still they did nothing and kept playing
games,=94 he tells Pharmalot. =93This was the last step anyone wants to
take. But I pointed it out to my supervisor and I was snubbed. I went to
HR and was snubbed. And I went to corporate compliance and I was
snubbed. So there=92s no choice. You have to defend yourself and tell the
story. But I would say that unless you have money and courage, keep your
mouth shut. Or you should probably just go to the authorities to report it.=
=94


Peter Rost at Question Authority has also written this. You can read it
here.



---------

Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
+1-206-229-2420
http://ramsolink.info/
www.cancersurvivorsproject.org
www.healthyskepticism.org
www.mavinfoundation.org