Bloomberg is running a massive piece on Pfizer, this morning -- and its $2.3 billion settlement with the DoJ -- mostly related to off-label promotion of Bextra. This is a fabulously comprehensive run-down of the history, here. But I saw scarcely any new details.
So, I'll admit that it made me wonder whether Jeff Kindler supported Mr. Bloomberg's opponent, last Tuesday. Heh. Answer, by clicking the NYC Campaign Finance Badge, at right I'll go look. [Or perhaps, now that he has been re-elected, the gloves come off, even if Kindler and Pfizer supported his mayoral candidacy.] In any event, while this long and devastating article breaks very little "new" ground, it does collect -- in one place -- most of the manifold evils of blockbuster off-label promotion, as it was practiced in the early part of the decade.
It also makes plain the calculus at least some upper-level managers silently made: "Will the fine be larger than the increase in profitability, from selling off-label?" And usually, the answer to that question was clearly "no" -- so off-label they went.
What the article doesn't do -- as good as it is -- is explain that the center-piece of the largest criminal fine ever paid for off-label promotion was actually presided over by Fred Hassan and Carrie Smith Cox (see mine on it, there). Both were most-recently in charge at Schering-Plough -- but back then, the pair was leading Pharmacia's efforts to bring Bextra to market, and turn it into a blockbuster (before they sold the company, that is -- "lock, stock and barrel" -- to Pfizer):
. . . .Pfizer bought Pharmacia & Upjohn (P&U) in April 2003. From 2001 to the end of 2003, P&U, first as an independent company and then as a unit of Pfizer, paid physicians more than $5 million in cash to lure them to resorts, where salespeople illegally pitched off-label uses for Bextra, P&U admitted in its Sept. 2 guilty plea.
Golf, Massages
"Pharmacia paid targeted physicians both airfare and two to three days’ accommodations at lavish resorts in the Bahamas, Virgin Islands and across the United States and further entertained these physicians with golf, massages and other recreation activities," according to prosecutors’ findings.
In her guilty plea, Holloway said her team had solicited hospitals to create protocols to buy Bextra for the unapproved purpose of acute pain relief. Her representatives didn’t mention the increased risk of heart attacks in their marketing.
They told doctors that side effects were no worse than those of a sugar pill, Holloway admitted in her guilty plea. . . .
Actually, heart attacks were among the side-effects. And Pfizer pulled the drug from the market in 2005, after being asked to do so by FDA. Do go read it all, but don't forget that Hassan and Cox were clearly in charge here, when the drug launched, and undoubtedly had a hand in overseeing all the messaging for this drug. Was there "a wink and a nod", about off label pain relief, from the pair? We don't know. [And don't misunderstand, Pfizer is culpable here, too -- as it plainly learned of all of this -- in its acquisition due-diligence, and chose to continue the practices.]
What we do know, now seven years later, is that the above seems to fit a pattern, for the pair -- Hassan and Cox. A pattern seen previously at Pharmacia -- in Celebrex marketing (and unfavorable study-results delay and minimization), and of course, in Vytorin/Zetia, most recently (unfavorable study results delay, and minimization). But this whole blog -- some 970 posts of it -- tells that story.
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