After India-based pharmaceutical giant Ranbaxy pled guilty to seven
felonies and agreed to cough up $500 million to U.S. authorities in May
this year, information on wrongdoing within the company has continued
to trickle out, including most recently compelling evidence that
erstwhile CEO and billionaire owner Malvinder Singh was alerted to the
fraud years ago.
In a recent series of news reports by CBS News here,
the whistleblower in the case and former Ranbaxy Director Dinesh Thakur
said that when his suspicions were initially raised and he set out to
look for more data, he was met with resistance and “It was a lot of
trying, like pulling teeth.”
In the case of at least 15 new generic drug
applications, auditors were said to have found more than 1,600 data
errors, implying that these drugs were “potentially unsafe and illegal
to sell.”
The CBS reports also carried statements by Kathy
Spreen, who was hired by Ranbaxy in 2004 to help the company comply
with FDA regulations, who said that she became alarmed when inspecting
bio-equivalence data for a Ranbaxy diabetes drug, because “The data
from the generic and the brand were identical,” and “Any time you see
perfect data, you’re probably looking at false data or inaccurate data
or made-up data. I started asking, ‘I need the data. I need the initial
raw data”.
However, Dr. Spreen said she could not get it, and went
right to the top, to Malvinder Singh and when she did that, “He held my
hand and he told me to just be patient and everything would be taken
care of.” Yet nothing came of that promise.
Import alert
Despite Ranbaxy’s felony charges earlier this year, a
potential indicator of continuing malpractice came as recently as
September when the FDA again issued an import alert against the
company, this time on drugs made at its Mohali plant.
No comments:
Post a Comment