shoveling…

Posted on Tuesday 18 September 2012

West Point’s Cadet Honor Code

Who is Alex Gorsky? He is a West Point Graduate who finished his Army Service as a Ranger in 1988 and went to work for Janssen. He began as a drug rep, rising up the ladder to President of the Janssen subsidiary of Johnson & Johnson in 15 years. He left for several years to lead Novartis, North America, and then returned to J&J and as of April 2012 is CEO for all of Johnson & Johnson with a base salary of around $6.8 M/year [oh yeah, he works with Boy Scouts]:

Alex Gorsky timeline


1978   US Military Academy at West Point
1982 US Army Ranger
1988 Sales Representative for Janssen
March 1995 Group Director in the psychiatry and other franchises
  Vice-President for the CNS Division
October 1998 Vice-President of marketing for Janssen
  Vice-President of sales and marketing for Janssen
October 2001 President of Janssen
February 2003 Group Chairman J&J in Europe
Fall 2005 CEO Novartis North America
February 2008 Group Chairman for Ethicon at J&J
September 2009 Chairman of Medical Devices & Diagnostics Group at J&J
April 2012 returned as CEO of Johnson & Johnson

During the years from 1995 to 2003, all of those positions had to do with Janssen’s Risperdal, the first of the blockbuster atypical antipsychotics. Many of the allegations against J&J have had to do with corrupt marketing practices during his tenure, and his lawyers have fought long and hard to keep him off the stand. This May Deposition is in a Pennsylvania Civil suit and his only testimony that I know of that’s publicly available. He was deposed for the Texas Trial but it wasn’t used in the trial last January. He was obviously well prepared for this deposition:

Q. Mr. Gorsky, before we look at this document, did you meet with your counsel before the deposition to prepare?
A. Yes, I did.

Q. In total, Mr. Gorsky, how many hours do you think you met with Mr. Murphy, Mr. Powers and/or Ms. Warren?
A. Ten hours, plus or minus.
The form of the Deposition is tedious. The Plaintiff’s lawyer produces a subpoenaed document and says what he thinks it means. Gorsky then tries to deny the suggested meaning and reframe it as J&J’s having motives as pure as the driven snow. After a bit of foiling, they move to the next document and repeat the dance. I’ll try to list the topics covered and reference the responses. It started with a review of J&J’s credo and Gorsky’s leading a training program about Marketing ethics [pages 4-6], establishing that Gorsky knew the proper rules and boundaries:

  • Omnicare: Omnicare is an eldercare chain. The two allegations were that the FDA had warned J&J not to advertise efficacy for Risperdal in the elderly for lack of evidence. Janssen neither told Omnicare nor their own sales staff of the warning. The second charge was that J&J paid rebates [kickbacks] to Omnicare to use more Risperdal [Omnicare has already admitted guilt and settled for $100 M]. Gorsky denies wrongdoing [page 6+].
  • Joseph Biederman: I’ve covered the Biederman story ad nauseum [see bipolar kids: not someone to jerk around…, bipolar kids: harvard for sale…, bipolar kids: harvard acts…]. J&J gave Joseph Biederman $500,000 to start a Research Center which was heavily oriented towards using Risperdal. In return, Biederman signed on to a J&J written study, did CME presentations, etc. In this deposition, the lawyers produced documents showing J&J’s plans to use Biederman to support off-label prescription of Risperdal to children. Gorsky claimed that J&J’s only motives were altruistic [Biederman has been censured by Harvard and apologized] [pages 14-35].
  • Prolactin: Risperdal elevates Prolactin levels producing breast enlargement and sexual side effects in some. J&J essentially ignored this fact. Gorsky acts as if he’s unaware of the problem [though this particular suit is about this problem]. These were Gorsky’s most evasive moments in the Deposition [pages 35-40].
  • Off Label Promotion to Children: I quoted the transcript in the last post [hear here]. The documents quote Gorsky about growing the pediatric market at a time when there were no pediatric indications. The question about how they could do that without off-label promotion was never answered [because it had no answer]. This was the most damning section of the Deposition, particularly with the TMAP testimony showing the Janssen reps pushing Risperdal for children to Doctors treating Medicaid and Foster children [the TMAP trial…, see Tone Jones testimony][pages 40-51].
  • Miscellaneous: Chortling together over a diabetic death in a competitor’s clinical trial, seeding the audience so a question would allow a CME speaker to talk about "off-label" uses, only showing positive findings on a poster, blah, blah blah…
I’m sorry I can’t do the Deposition more justice. It’s just the way the courtroom game is played. The interrogator showing concrete examples. Gorsky playing dumb, not remembering, being evasive, walking the line between not admitting guilt and not committing perjury. The result is a dance of smoke and mirrors all to create a video for the jury to evaluate if it ever even comes to that. Hardly up to West Point Honor Code, the Ranger’s Creed, the J&J Credo, or the Boy Scout Oath.

The documents speak for themselves – loudly. And in many ways, the Deposition itself is exemplary of the crime. The misleading graph or table in the ghost-written paper is like Gorsky’s answers – sins of omission or distortion rather than out-right lies. Janssen’s dealings with Omnicare were shady – benefiting Omnicare and Janssen, but not the old people being cared for. Joseph Biederman sold his expertise and did pay with deliverables – ultimately delivering hard to control kids to the antipsychotic market. Janssen did ignore the Prolactin problem to the detriment of many patients. The off-label promotion of Risperdal for use in kids was rampant, and was on purpose. There really were any number of miscellaneous misdeeds along the way. The claims of altruism and adherence to their credo really were window-dressing to cover a now obvious truth.

Alex Gorsky is a looker, a Ranger, a West Point graduate, has a Wharton MBA, makes at least $6.8 M/year, and his whole career has been involved with selling an Atypical Antipsychotic to people, the majority of whom would’ve been better off not taking it. Johnson & Johnson Stockholders will keep their ill-gotten gains from earlier and take a small future hit from the penalties levied by the courts. Gorsky’s salary and benefits will grow if he can continue to deliver on Wall Street. If not, he’ll float down on a golden parachute and be replaced by a clone.

While it’s hard to be excited by this outcome, it is, in fact, progress. At least there are penalties. At least there’s exposure. At least some of us are wiser and noisier than we were a decade ago. White collar crime is inevitable in a Capitalism such as ours. The temptations are just too great. But with the modern pharmaceutical industry, it became a way of life – at least in the realm of CNS drugs. That could never have happened without the complicity of a thick layer of highly placed physicians. With Risperdal, there were many – those involved in the guidelines, the TMAP algorithms, the Texas State Mental Health system [see pay the price…], the doctors at the eldercare facility, academicians like Joseph Biederman and his associates, the Janssen physicians, the doctors writing the prescriptions too freely. I guess step one if you’re going to clean out the Augean Stables is to look around and see how much shit needs to be shoveled…
 

UPDATE: Well, maybe there will be more after all!
  1.  
    Steve Lucas
    September 19, 2012 | 8:00 AM
     

    I have commented before, and continue to believe, that pharma’s business model is based on its action regarding psychiatry. Control the KOL’s, who in turn control the universities, who in turn produce the result that are massaged by ghostwriters, and sell a product of little or no value.

    We can see at this link:

    http://www.economist.com/node/18114873

    This quote:

    “Professor Philippe Even of the Institut Necker, a research body, reckons that, of 5,000 or so drugs available in France, “nearly half serve no useful purpose”, and many of those may be harmful. In 2010 the French public-health system had a €12 billion ($16 billion) shortfall. Spot the connection.”

    Today psychiatry is being practiced by those with a MS or lower as they do the interviews and speak with patients while doctors have been regulated into a drug only prescribing regime by pharma’s marketing efforts.

    Pharma would like nothing less than to move this model to the general population where everything can be solved with a pill and everyone is medicated, needed or not.

    While logical fallacies and straw man arguments abound the grim reality is pharma has honed its marketing plan for decades, and uses its outsized profits to buy access and input into the very bodies charged with regulating and overseeing its operations.

    Steve Lucas

  2.  
    September 19, 2012 | 11:37 AM
     

    Risperdal reproached.
    Same saga here as Eli Lilly Zyprexa.
    Johnson and Johnson is a trusted brand we associate with babies.
    Risperdal,Zyprexa,as well as the other atypical antipsychotics, are being prescribed for children, even though this is an unapproved, off-label use. An estimated 2.5 million children are now taking atypical antipsychotics. Over half are being given them for Attention Deficit Hyperactivity Disorder,many of these foster children.
    Weight gain, increases in triglyceride levels and associated risks for (life-long) diabetes and cardiovascular disease.
    Eli Lilly made $67 BILLION on Zyprexa!
    *Tell the truth don’t be afraid*
    –Daniel Haszard FMI http://www.zyprexa-victims.com

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