Wednesday, February 25, 2009

FRAUDULENT SLIP

Forest Accused of Fraud re: Celexa and Lexapro

My goodness, we haven't seen the Justice Department this active in pharma cases in a very long time. But after the recent major DOJ actions against Lilly/Zyprexa and Pfizer/Bextra, it looks like Forest's promotion of Celexa/Lexapro (mirror images of the same molecule) is the next target. This according to the New York times, as described here:

http://www.nytimes.com/2009/02/26/business/26drug.html?ref=business

As described in the article, the charges will remind most of us of Paxil--suppressing negative studies on the antidepressant, and particularly regarding its effect on kids. Suicidality appears to be, yet again, part of what remained unreported. And all this in the context of unapproved promotion and, it appears, some whistleblowers within the company.

From the perspective of this observer, it does appear that the Justice Department is reviving itself. This is not to say it has all happened in the last few weeks. Cases like this take years to develop. But perhaps there is a new commitment to actually friggin do something.

Pardon my Scottish.

13 comments:

  1. Foreplay and freudian...er, fraudian slips? Pharmalittle's resident analyst is on a roll...
    as are the Feds. Emory University is still under the Feds' microscope. Click on "Glad" to read the story.

    ReplyDelete
  2. Justice, the scope of this investigation is impressive. Read what Alison Bass is sayin' here:

    http://alison-bass.blogspot.com/

    ReplyDelete
  3. Thanks, Glad.

    BTW, what comes to mind about that?

    (sometimes a microscope is a microscope)

    ReplyDelete
  4. Thanks for the heads up on Alison B's blog, Nancy. I assume that this is all happening under the False Claims Act, but I don't see that explicitly in either the NYT or AB's blog (perhaps I'm missing it).

    One of the things that Eric Holder, our new AG, has advocated in the past is rewarding companies for doing their own internal investigations. Of course, this assumes that a broad swath of senior management is not involved. If it's a few "bad eggs," and they are nailed by the internal investigation, than the company as a whole is spared some.

    Again, this does not appear to be the issue in the Forest case--looks like whistleblowers working with DOJ--but it's an interesting model--kind of a DOJ PDUFA.

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  5. Ah, Sigmund. Yes, sometimes a cigar is just a cigar (as they say in the biz).

    As I free associate about the content of the Wall Street Journal article "U.S. Probes Emory Doctor's Glaxo Ties," a song comes to mind...

    If interested, click on "Glad."

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  6. Justice, according to the news released by the District of Massachusetts U.S. Attorney's Office,

    "A Complaint was unsealed today in U.S. District Court in Massachusetts against a New York pharmaceutical company for alleged False Claims Act violations arising from the company’s marketing the drugs Celexa and Lexapro for unapproved pediatric use and for paying kickbacks to induce physicians to prescribe the drugs." The news release is posted here:

    http://www.usdoj.gov/usao/ma/press.html

    ReplyDelete
  7. Thanks, Nancy. Yeah, as anticipated, I learned through the WSJ Law blog that this is, indeed, a qui tam (whistleblower) suit brought uder the False Claims Act.

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  8. For folks who don't want to paste in the link, here is the core of the DOJ summary:

    "The Complaint alleges that a double-blind, placebo-controlled, pediatric trial found Celexa no more effective than the placebo for pediatric use and that, in the study, more patients taking Celexa attempted suicide or reported suicidal thoughts than those in the group taking the placebo. The negative efficacy data led the FDA to deny FOREST’s request to approve Celexa for pediatric use. It is further alleged that, despite the FDA’s denial of a pediatric indication, FOREST actively promoted pediatric use of the drugs and misled physicians and the public by failing to disclose the results of the negative study. The same study was among those later considered by the FDA when it mandated that FOREST add a “black box” warning to both the Celexa and Lexapro labels.

    The Complaint alleges that FOREST sought to induce physicians and others to prescribe Celexa and Lexapro by providing them with various forms of illegal remuneration, including cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment and other valuable goods and services, all in violation of the federal anti-kickback statute."

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  9. And the beat goes on....paxil revisited. Sadly these complaints come up, but the prescribing continues.

    ReplyDelete
  10. The Michigan joins suit piece is interesting. Up to now, Michigan has absented itself from joining such suits--sometimes the only state that has done so--and our AG Mike Cox has been asked why.

    A new era in the Great Lakes State? We'll see.

    ReplyDelete
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