There are absolutely no surprises here — but Ed Silverman (he, the crown prince of the kingdom far, far away — called Pharmalot) has a great piece up, on the newly unsealed litigation document troves, from the Pharmacia-era Celebrex® off-label promotions, and study-results-delays and study-fudging debacles. Do go read it all.
Lest anyone here forget — this massive, multi-billion-dollar train-wreck occurred in slow-motion, over a period of four years, while legacy Schering-Plough CEO Fred Hassan was at the helm of Pharmacia — and was being aided directly by Carrie S. Cox (also his No. 2, at legacy Schering-Plough), thus:
. . . .Each of the Pharmacia Director Defendants was privy to information at the highest level of Pharmacia. Each of the Pharmacia Director Defendants [including Fred Hassan, and Executive Officer Carrie Cox] knew or should have known the true state of affairs at Pharmacia, the serious and substantial problems related to Pharmacia’s marketing of risky products (including Celebrex and Bextra) and Pharmacia’s liability for injuries allegedly related to those products. . . .
On February 1, 2005, the Boston Globe reported on the 1999 Alzheimer’s study, stating, “Pfizer, Inc, has revealed it completed a study four years ago [then known as Pharmacia] that links its painkiller Celebrex to a ‘statistically significant’ increase in heart problems. The recent disclosure. . . appears to contradict recent statements by the company”. . . .
When all of the CLASS data were considered, most or all of Celebrex’s purported safety advantage disappeared. Six of the seven serious gastrointestinal complications occurring during the second half of the study were in Celebrex users. . . .
And, as Ed’s new piece notes, recently released documents from marketeers at Pharmacia crow that “They swallowed our story, hook, line and sinker.” That was senior research director Samuel Zwillich, in a 2000s-era e-mail to a colleague.
Ugh. Thus — as we’ve repeatedly documented — was born the largest criminal fine in the history of US Pharma. It was a playbook they both would repeat, while leading legacy Schering-Plough (2004 to 2010) — with the combo-drug Vytorin®. Thanks again, Fred and Carrie!