Ian Hudson’s “significant involvement” with Paroxetine

Ian Hudson worked at SmithKline Beecham for 11 years (Glaxo 2 weeks) as Worldwide Director of Safety. He then joined the MHRA as its Head of Drug Licensing.

During his time at SmithKline Beecham and Glaxo he had significant involvement a number of drugs, especially Paroxetine (Seroxat) and two others. We know this because of this document – Ian Hudson Interests – which he filled in before joined the European Medicines Agency.

I’ve mentioned it before, but he used to be such an authority on Seroxat that Glaxo put him forward as a defence witness in the Tobin/Schell case (in fact, he gave evidence for Glaxo alongside David Wheadon).

See below for this entry from the Seroxat Timeline.

June 14 2001:
People can’t get hooked on Seroxat as they did on the older drugs such as Librium and Valium, claims GSK.
For over a decade, the company line has been swallowed, along with the pills. But a court case in Wyoming, USA, has changed all that. The jury decided Seroxat – Paxil in the USA – was to blame for Donald Schell killing his wife, daughter, baby granddaughter and then himself.

Enter Ian Hudson, witness for the defence and at the time of his deposition earlier in 2001, worldwide safety director for GSK. That’s Ian Hudson, now director of licensing at the Medicines Control Agency in the UK (later to become the MHRA).

What did he have to say to the evidence of Mr Schell’s closest remaining family and three psychiatrists who all believed the tablets of Paxil/Seroxat Mr Schell took for just two days precipitated him into an unnatural and totally uncharacteristic murderous and suicidal frenzy? His position is that an individual case cannot tell you one way or the other – only randomised controlled trials will do.

But Dr David Healy says that randomised control trials are the wrong tool to establish whether serious side effects are occurring. The way to investigate what is happening is to carry out a challenge-rechallenge trial, where people are given the drug, taken off it and then put back on.

But GSK has not carried out that sort of study to establish whether or not Seroxat can make people agitated, suicidal, murderous or hooked. Nor has it carried out a randomised controlled trial. Here is a black hole. There is no proof that the drug does these things, says GSK, and because of that there is no reason to carry out trials that might decide it one way or the other.

Does Mr Hudson still take that view now he is at the MCA (later to become MHRA), which watches over the safety of the British public? “If he takes the position with the MCA that he took at the trial, then none of us is safe with any drug in the UK at the moment,” says Dr Healy. How would Mr Hudson even be able to blame alcohol for making someone drunk?

So what does Mr Hudson think? As always, the MCA declines to answer detailed questions.

The MCA will (?) have been supplied with all the healthy volunteer data before it granted the licence for Seroxat. It doesn’t seem to have been worried then, which makes one wonder who, exactly, was steering them as to what it meant.

More on Hudson here and here.

You’ve got to ask what exactly does a “significant involvement” actually mean.

I’d like to know.

2 Responses to “Ian Hudson’s “significant involvement” with Paroxetine”

  1. RB Says:

    Something is certainly Rotten in the state of the MHRA…

  2. truthman30 Says:

    Any involvement with paroxetine is significant , particularly because Mr Hudson was a former High Level Employee of GSK and is now a high level employee of The MHRA…

    How can we trust any of the drugs that they regulate…?
    I for one, do not….


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