About Pharma Industry

BNET Pharma provides daily industry trends and news coverage with insights for managers and executives about major manufacturers of pharmaceuticals and medicine. In addition to detailed drug company profiles, we bring you industry analysis on new partnerships, drug patents and products, cost management, investments, pharmaceutical related lawsuits, and a host of other important business issues.

How Pfizer Hid a $2.3 Bill. Bextra Settlement in Plain Sight

By Jim Edwards | Jan 26, 2009

BNET pointed out today that the announcement of Pfizer’s acquisition of Wyeth formed a welcome distraction (for Pfizer) from the news that the company was also paying a $2.3 billion settlement to make the Department of Justice stop investigating the company’s illegal promotion of discontinued Cox-2 painkiller Bextra.

The company said the Bextra investigation had been “previously disclosed”:

Fourth-quarter 2008 results were impacted by a $2.3 billion pre-tax and after-tax charge resulting from an agreement in principle with the Office of Michael Sullivan, the United States Attorney for the District of Massachusetts, to resolve previously disclosed investigations regarding allegations of past off-label promotional practices concerning Bextra, as well as other open investigations.

… [there was also an] after-tax charge of $640 million resulting from the agreements in principle to resolve certain litigation involving the Company’s non-steroidal anti-inflammatory (NSAID) pain medicines in third-quarter 2008

So why was the size of the settlement — a 90 percent reduction in its net income — such a nasty surprise if everyone knew it was coming?

The answer is that although Pfizer did previously disclose the investigation, it was disclosed to the SEC but not in Pfizer’s press releases. And those disclosures didn’t mention that the sum would be one of the largest Pfizer has ever paid to settle a case. It makes the Neurontin settlement look like laundry quarters.

The existence of trouble with the feds on the Bextra issue was first disclosed on Pfizer’s 10Q quarterly earnings filing with the SEC for Q2 2008. It said:

The Department of Justice continues to actively investigate the marketing and safety of our COX-2 medicines, particularly Bextra, and more recently has begun to investigate the marketing of certain other drugs. These investigations have included requests for information and documents. We have been considering various ways to resolve the COX-2 matter, which could result in the payment of a substantial fine and/or civil penalty.

But Pfizer’s earnings press release made no mention of the probe.

The same thing happened in Q3. Here’s what Pfizer told the SEC:

The settlement agreements and agreements in principle [on unrelated Bextra cases] and the charge to earnings do not apply … to the pending investigation by the Department of Justice of the marketing of the Company’s COX-2 medicines, particularly Bextra. The Department of Justice investigation could result in the payment of a substantial fine and/or civil penalty.

But the press release contained nothing.

The settlement likely wraps up and seals documents that the feds have extracted from Pfizer in their investigation. Which means the chances of any enterprising journalist getting to tell the tale of what, exactly, Pfizer did to earn this massive fine, is slim.

The lesson here is clear: The news media (BNET included) lazily looked at the press releases and not the SEC diclosures, and thus didn’t bother to ask the difficult questions. But also note that Pfizer didn’t make it easy for us, either. The telling detail that Bextra’s promotion was “off-label” only came with the merger announcement, not in the previous disclosures.

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

BNET User Analysis

Web Buzz:
  • Pfizer takes $2.3B Bextra charge

    Fierce Pharma - 301 days 2 hours 5 minutes ago

    News of the Pfizer-Wyeth merger this morning drowned out some not so good news for the company. Just after announcing its $68 billion buyout of Wyeth, Pfizer published its 2008 fourth quarter earnings report. In it, Pfizer reveals a $2.3 billion charge to end investigations into allegations of off-label promotions of the company's COX-2...

  • Pfizer to pay $2.3 billion in Medicare/Medicaid Fraud

    Healthcare Economist - 82 days 6 hours 51 minutes ago

    This past February, I wrote about the spread of physician learning concerning harmful side-effects of Cox-2 inhibitors, including Bextra.  Today, The New York Times reports that Pfizer has agreed to pay a $2.3 billion settlement with CMS over the company’s illegal promotion of its now-withdrawn painkiller, Bextra. “Marketing fraud cases...

  • Pfizer - Bextra: DOJ press conference

    PharmaGossip - 82 days 6 hours 14 minutes ago

    Justice Department Announces Largest Health Care Fraud Settlement in Its History Pfizer to Pay $2.3 Billion for Fraudulent Marketing WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together "Pfizer") have agreed to pay $2.3 billion, the largest health care fraud...

  • Pfizer's Wyeth Buy Eclipses $2.3 Bill. Bextra Troubles; 19,000 Layoffs to Come

    BNET Pharma - 301 days 7 hours ago

    Today's announcement that Pfizer is to acquire Wyeth for $68 million eclipsed some things that on any other day would have been headline news in themselves: a) The fact that Pfizer's earnings were down 90 percent due to a $2.3 billion settlement with the Department of Justice over its off-label promotion of Bextra, the Cox-2 painkiller. And b),...

  • Pfizer agrees to plead guilty in painkiller case

    Financial Times - 82 days 4 hours 7 minutes ago

    Pfizer, the world’s largest pharmaceutical group, on Wednesday agreed to plead guilty to illegally promoting its painkiller Bextra, as part of a record-breaking $2.3bn final settlement reached with federal and state authorities across the US. The company signed a “corporate integrity agreement” with the Department of Health and Human...

 
Reply to Story

BNET TalkbackShare your ideas and expertise on this topic

Subscribe to this discussion via Email or RSS

  •  
    1

    john@...

    01/31/09 | Report as spam

    RE: How Pfizer Hid a $2.3 Bill. Bextra Settlement in Plain Sight

    Hopefully BNET and Justice will now investigate Pfizer's Chantix (varenicline). Chantix is killing smokers who are trying to quit and save their life, when Pfizer's only study pitting Chantix against NRT found no statistical advantage for Chantix over nicotine patch at either 6 months or 1 year when analyzing 7 day point prevalence rates (Have you smoked in the past 7 days?). Ask yourself this question, BNET, and trust your common sense. Is it possible that Pfizer found some means in its clinical trials to hide from placebo quitters the onset of full blown nicotine withdrawal when ordered to attempt to stop smoking on study day 8, or that active group users didn't notice varenicline's nicotine blocking effects by study day 7 and the fact that smoking was like smoking a carrot: for the first times in their smoking lives there was no dopamine "aaah" explosion 8-10 seconds after a puff? We're killing quitters when Pfizer's own science says it's no more effective than quitting products that don't kill smokers, when Pfizer's claimed science isn't science at all.

Please add your comment:

  1. You are currently: a Guest |
  2.  

Basic HTML tags that work in comments are: bold (<b></b>), italic (<i></i>), underline (<u></u>), and hyperlink (<a href></a)

advertisement
advertisement
  • Click Here
  • Click Here
  • Click Here
advertisement