Seroxat/Paxil addiction studied by Glaxo… or not?

This a repost – originally from March 2007. It’s worth reading again because of recent legal stuff that I can’t talk about at the moment.

You might think that after all the years of doctors and patients all around the world saying Seroxat is highly addictive and Glaxo saying “Oh no it isn’t” – that Glaxo would simply undertake the definitive study to prove us all wrong and to show the world once and for all really how safe and non-addictive Seroxat is… well, it turns out Glaxo has already done this – or maybe they haven’t….?

Confused – now read on.

Finding a copy of the Paxil Protest website once again has been great. It’s a veritable treasure trove of fantastic stories and link, such as this one:

The following exchange is from a transcript of a video deposition taken from Dr. David Wheadon, who was at the time, Vice President Regulatory Affairs and Product Professional Services, GlaxoSmithKline, in Philadelphia, PA on Thursday, October 19, 2000 prior to the Tobin/Schell civil suit.

Questioning Dr. Wheadon were California attorney Donald J. Farber and Texas attorney Andy Vickery.

Paxil Victim’s Attorney: I’m asking you to kind of elevate yourself above this particular paper and go to your general knowledge now on Paxil. You have been now with the company eight years, and you have studied and are aware, I presume, of Paxil’s traits in either causing or unrelated to addiction and withdrawal, and based on that general knowledge I think you probably have, do you consider as a labeling instruction today that this paragraph, physical and psychological dependence, is a good labeling instruction?

GlaxoSmithKline’s Dr. Wheadon: Well, quite frankly, it is an outdated labeling instruction, because there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been.

That’s clear enough then – Paxil (Seroxat) has been studied a number of times in humans looking at the potential for Paxil for abuse, tolerance and physical dependence… and of course, Dr Wheadon was under oath – so he had to tell the truth – didn’t he?

The problem is that seven years later, the official Paxil prescribing information (produced by Glaxo) provides the world with a statement in stark contrast to Dr. Wheadon’s testimony.:

DRUG ABUSE AND DEPENDENCE
Controlled Substance Class: PAXIL is not a controlled substance.
Physical and Psychologic Dependence: PAXIL has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic…

Just to recap:

…there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence… (2000)

…PAXIL has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence… (2007)

So while Wheadon said one thing (under oath) in 2000, Glaxo says the EXACT opposite in its current [March 2007] official prescribing information.

One of these statements has to be a lie.

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