|Sally K. Laden The Paxil Ghostwriter|
Much has been said about the fraud behind GlaxoSmithKline's Paxil 329 study, most of it negative. Fingers have been pointed at Marty "Bling Bling" Keller for putting his name to the study...or rather accepting money from GSK to have his name as the lead author. Glaxo themselves have been blamed, and rightly so.
I've yet to see anyone point the finger of blame on the ghostwriter, one Sally K. Laden.
Laden [no relation to Osama Bin] has pretty much come out of this unscathed, hey she was only doing her job - maybe so, but over the years she has had more than one opportunity to come clean or, at the very least, chastise Glaxo for duping her... if indeed she was duped?
So, who is Sally K. Laden?
Laden graduated in 1981 from the University of Connecticut with a Bachelors degree in Pharmacy and in 1983 from the Kansas University with a Masters degree in Hospital Pharmacy.
In 1985 Laden became the Associate Editorial Director - Scientific Therapeutics Information [STI]
She has been self employed since 2003, working from home for the business she founded, MSE Communications LLC where she is a Freelance Medical Writer. According to her LinkedIn profile she is also a Developmental Editor for Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, and has been since January 2013.
Laden is also a member of the American Medical Writers Association.
Her home and business address is situated in an affluent part of Cheshire, Connecticut, where she lives with her husband Michael.
The Deposition of Sally K. Laden
On March 15 2007 Laden was deposed (gave evidence under oath) by attorneys for the cases Cheryl J Cunningham et al versus SmithKline Beecham Corporation (GlaxoSmithKline), William P Williams versus SmithKline Beecham Corporation (GlaxoSmithKline) and Christopher Shibley versus SmithKline Beecham (GlaxoSmithKline). It's a fascinating deposition, particularly the way GlaxoSmithKline's defence attorney, Todd Davis (King & Spalding) is, on many occasions, shot down in flames by plaintiff attorney, George Murgatroyd (Baum Hedlund).
Representing Laden were Attorney Stuart Margohs (Berdon Young & Margohs) and Deanna Levine.
I'll address the 'shooting down in flames' later in this post. It's actually very satisfying to see a representative of King & Spalding being firmly put in their place.
Q: Now you understand that you're here today in connection with lawsuits involving the drug Paxil?
Q: Okay, are you familiar with what the allegations are in any of the complaints?
A: Yes I am
Q: Okay, and what is your understanding of what they are?
A: Well my understanding is that the Plaintiffs children took their own lives while taking Paroxetine.
I think it's a good idea to read that last line of Laden's depo again. This deposition of Laden wasn't about her being paid to write the 329 study, it was about children taking their own lives whilst on GlaxoSmithKline's antidepressant Paxil.
The question is, did Sally K. Laden know that Paxil wasn't safe or effective in children before or during the time she wrote the study?
Let's move on...
Laden confirms to Murgatroyd that she was employed by Scientific Therapeutics Information [STI]
Q: Okay, is having articles published in peer review medical journals one way in which a drug company can promote it s drug to prescribing physicians?
A: No I don't consider that promotion.
Q: Okay, and would you agree that a journal article that you wrote that was positive in terms of the drug's efficacy and safety would help the drug company with the sale of it s drugs?
A: No I can't agree. I don t agree with that.
Q: Okay Well other than medical writing you said you were also involved in the business of setting up meetings?
Laden answers 'yes' and is then asked what type of meetings she set up for GlaxoSmithKline...
A: Advisory boards Large CME (Continuing Medical Education) symposia at national meetings Such as the American Psychiatric Association (Laden later adds the American Academy of Family Physicians, Consulting meetings and consensus conference programs to her list)
Once I arrived at page 12 of the depo I was greeted with redacted text, this, as I understand, is due to the fact that Glaxo obtained a protective order. I may be wrong and there may be another reason for redaction. You can read about protective orders here, if so inclined.
The First Draft
Q: Do you know why it took you until December 18 1998 to prepare the first draft of this Study 329?
Q: Okay, where did the data come from that ended up in this first draft?
A: A clinical study report was provided to me.
Q Okay, who was that provided by?
A: I don't remember the person who sent it to me.
Q: Okay, but it came from GSK?
Murgatroyed then asks Laden if she received the entire clinical study report, which, he adds was "over 1400 pages."
Laden answers, "A clinical study report that STI would normally receive would probably be about 200 pages in length." She later adds, "I believe it's considered a synopsis of the report rather than each individual patient's data"
So, it's pretty crystal clear, to me at least, that Glaxo handed over a report to Laden that was condensed, watered down, cherry picked.
Lighting the Blue Touch Paper
Murgatroyed asks Laden to read the conclusion of her first draft. She reads:
"Paroxetine is a safe and effective treatment of depression in the adolescent patient. Further studies are warranted to determine the optimal dose and duration of therapy"
Q: Okay, and when you wrote those words were you aware that Paxil failed to achieve statistical significance in any but four of the 25 efficacy parameters that were analyzed by GSK?
A: I don't remember, you know, what I was aware of. This does not look outside the realm of what is standard. I reported the data accurately as far as I can tell in this result section that listed the items that were statistically significant.
Q: Well the final clinical study report clearly identifies two primary efficacy variables right?
Q: Yet your table three lists eight?
Q: How did that happen?
A: I don't know
Q: The primary study report lists five secondary efficacy variables. Your table four entitled Secondary Efficacy Variables lists three.
Q: How did that happen?
A: Again I do not remember those specifics.
Later Murgatroyed asks Laden the following:
"Prior to you preparing the first draft of the manuscript for Study 329 were you made aware of a position piece that GSK had internally developed that discussed the results of Study 329?"
Laden answers, "I don't remember". Murgatroyed replies, "Okay, then let me show you."
This seemed to cause great concern for the GlaxoSmithKline representative Todd Davis [King & Spalding]. Here's the dialogue between Murgatroyed and Davis.
DAVIS: I will object to the use of that document. This witness there wouldn't be any foundation that can possibly be laid that the witness is familiar with it or had any involvement with it And if you grant me a standing objection that will prevent me from having to object every time. Any problem with that?
MURGATROYED: I think we have already agreed Todd that all you have to object to is the form of the question. All other objections are reserved for the Court's ruling.
DAVIS: So will you grant me that objection both of you?
MURGATROYED: I'm not going to grant you any objection. We already agreed that all objections are reserved until time of trial with the exception to the form of the question.
DAVIS: Let's move it along.
MURGATROYED: I know this document is very upsetting to you and GSK but that s tough.
DAVIS: It's not upsetting, It's just the fact that we are here talking about a document with a witness that doesn't know anything about it. It s not a very effective use of everyone's time.
Murgatroyed 1 Davis 0
Murgatroyed then discusses the document that Davis was, it appears, panic-stricken over.
Q: Were you made aware that GSK was disappointed about the results of Study 329?
Murgatroyed then asks Laden to read an internal GSK email from the document. She reads the following:
"As you well know the results of the studies were disappointing in that we did not reach statistical significance on the primary end points. And thus the data do not support a label claim for the treatment of adolescent depression."King & Spalding attorney Todd Davis tries one more time to halt Murgatroyed from proceeding with his line of questioning...
DAVIS: Excuse me. And of course there has been no foundation laid by the questioning that this witness can answer any questions about this document.
Back to Murgatroyed questioning Laden...
Q: Let's take a look at the position piece that is attached to this email. What is that date?
A: October 1998
Q: And again that's two months prior to you submitting your first draft of the manuscript for Study 329?
Once again, Murgatroyed asks Laden to read the attachment. She complies:
"However the study failed to demonstrate a statistically significant difference from placebo on the primary efficacy measures."Murgatroyed then asks Laden to read another paged of the attachment, once again she complies with his request:
"To effectively manage the dissemination of this data in order to minimize any potential negative commercial impact."
Murgatroyed then asks Laden, "Are you familiar with the term potential negative commercial impact?"
Once again, King & Spalding's Todd Davis seems to blow a gasket.
DAVIS: This witness cannot speak to that document and what it means. And you have already deposed somebody We are wasting our time.
MURGATROYED: I m sorry, you can object to the form.
DAVIS: I object to the form. I also object that this is just a complete waste of time to ask this witness questions about a document she knows nothing about.
MURGATROYED: Todd, just object to the form and let s move on. That's the rules.
DAVIS: When did you say you're going to be done because I'm going to hold you, this is silly. It's silly.
MURGATROYED: Todd, I'm sorry this is upsetting to you.
DAVIS: It's not upsetting, It's a waste of time.
Murgatroyed 2 Davis 0
I must remember that should I ever cross paths with George Murgatroyed to buy him a drink of his choice.
End of Part One
Part II HERE