Saturday, October 17, 2009

From Searle, to Pharmacia, to Pfizer -- Bextra®'s Path to Ignomy (and CEO Hassan's Role In It)

I want to be fair to CEO Fred Hassan, and Carrie Smith Cox, in describing the role of each in securing -- years later -- what would be the largest criminal fine ever paid by a pharmaceutical company, for false, deceptive and/or off-label drug claims. So here is some background:

From the time Fred Hassan arrived at Pharmacia (late of AHP), on March 31, 2000, many felt it was clear that he was continually angling to sell the company off, either in total, or in bits and pieces. [He brought Carrie Smith Cox over, effective March 31, 2000, as well.]

The drug that ultimately cost Pfizer $1.2 billion, as of yesterday -- and was branded as Bextra® (Valdecoxib) -- was approved by the FDA about eighteen months after Hassan took over at what was then Pharmacia & Upjohn. As all of the whirlwind was gathering around Bextra (and another Pharmacia drug called Celebrex®), Hassan and Cox were obviously hard at work -- some say "turning the company around", while others would say they were simply crushing, slashing and burning whole business units, to make the then-filleted, and deep-fried company more attractive for resale -- to any buyer that might simply soak up the revenue from all these products, and minimize the acquired overhead.

In either version, quarterly sales of Bextra and Celebrex were accelerating -- like a 747 off the end of the longest-runway at LAX. [However, the arguably unlawful ways in which this acceleration was being acheived, by the marketing teams under Hassan and Cox, was not yet known by most of the public.] For the eighteen months before approval of Bextra then, Hassan and Cox must have helped shape the messaging for launch. A little more history, then, via my edits of, and notes on a Wikipedia entry, here:

. . . .In 1995, Pharmacia & Upjohn was formed from the merger of Pharmacia AB and The Upjohn Company, and in 2000, Pharmacia & Upjohn acquired GD Searle & Company, the pharmaceutical businesses of Monsanto.

Valdecoxib was to be manufactured and marketed under the brand name Bextra by Searle. It was approved by the US FDA on November 20, 2001, after Pharmacia had acquired Searle. Pfizer then acquired Pharmacia in April 2003. Bextra was available by prescription in tablet form until 2005, when it was removed from the market due to concerns about possible increased risk of heart attack and stroke. . . .

So -- now matter how you slice it, both the Bextra off-label promotions, and the Celebrex study disclosure delays (sound familiar?) were "on Mr. Hassan's, and Ms. Cox's, watch" at Pharmacia, netting each multiple scores of millions. In fact, it is fair to say that those actions -- in part -- led to the relatively-high price Pfizer paid for Pharmacia in April 2003, as the problems were not yet fully-vetted by investigations underway in the various US Attorneys' offices in Boston, Manhattan and Newark.

From there, Mr. Hassan, and Ms. Cox, arrived at Schering-Plough, and this entire blog tells the story of what has happened, since then. Was the Schering-Plough story a "turn-around", or a "bust-up"? You decide -- but here's a hint: usually, in a true "turnaround", the recovered company doesn't wink out of existence.

Those are all facts, as established by public documents -- and government filings -- in many cases, by the involved individuals, themselves.

Res Ipsa.


Anonymous said...

Res ipsa loquitur


Condor said...

Quite so, Salmon.

Quite so.

The broader continuing discussion of these matters -- over on pharmalot -- has been enlightening, as well.


Condor said...

Is this where you'd leave a comment?

I'd get it as a draft -- in moderation.

Feel free, Antonie Brentano. I'll be the only one who sees it.

Namaste -- Your buddie, your pal.

condor said...

New masthead -- now up -- see upper right portion of the glassy Merck-ified globe. . . .

We update the description to include stories on implementation of Obamacare.