MHRA and Ian Hudson – still questions to be answered

Things have moved on at the MHRA so they tell us… it wants to be more open, it wants to engage with us…

Well, I’d like it to be more open about one of its employees, Ian Hudson.

I’ve been wanting to get to the truth since January 2005 when the House of Commons Health Select Committee questioned some senior MHRA members about Seroxat (Paxil).

Here’s some background: 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” with 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 Hudson is such an authority on Seroxat that Glaxo used him as one of their defence witnesses in the famous Tobin/Schell case (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 MHRA, which watches over the safety of the British public? “If he takes the position with the MHRA 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 MHRA declines to answer detailed questions.

The MHRA 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.

The strange thing is that on the day the House of Commons Health Select Committee wanted to hear evidence from the MHRA specifically about Seroxat trial data and safety, Professor Alaisdair Breckenridge (MHRA Chairman), Professor Kent Woods (MHRA CEO) and June Raine (MHRA Director of Vigilence and Risk Management) all managed to attend the hearing.

MPs had expected to be able to question Ian Hudson as well… unfortunately Dr Hudson could not attend as he had a prior engagement.

At the time, the UK press reported Ian Hudson’s non-appearance at the House of Commons like this: “Members of the House of Commons select committee on health appeared angry that they were not able to question one of the employees of the United Kingdom’s drug regulatory authority at a session last week looking into the influence of the drug industry. Although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. Dr Hudson is a member of the agency’s executive board and was worldwide director of safety at SmithKline Beecham from 1999 to 2001, having worked for the company since 1989. Dr Hudson joined the agency’s predecessor, the Medicines Control Agency, in January 2001 as director of the licensing division. MPs wanted to question Dr Hudson about the company’s drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States). They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18. In June 2003 the agency advised doctors that patients aged under 18 should not be prescribed the drug.”

I know someone who attended the hearing that day as well, and he confirms that David Hinchcliffe, the Chairman of the meeting was angry & exasperated “There was a great feeling of cover up, or at least that’s what I felt sitting there nearby Charles Medawar. Charles Medawar’s overall demeanour was one of anger, alongside David Hinchcliffe who was also angry & exasperated…”

The transcript of the hearing is here, read around question 783 for a flavour of how the committee and Chairman felt.

In response to a Freedom of Information request, the MHRA has made public an email, download here – Witnesses for Thursday.pdf – apparently showing that Hudson’s non-appearance was agreed in a phone call between Lord Warner (government Health minister) and David Hinchcliffe (meeting Chairman) just a few days before the hearing. This email was from Neil Townley at the Dept. of Health to David Harrison – the Clerk of the committee (and copied to Professor Sir Alasdair Breckenridge.

However this exchange from the hearing is most interesting:

Q790 John Austin: I think it would have been useful if Dr Hudson had been here because, as far as I understand, he was at SmithKline Beecham and his department was responsible for the collection of adverse reaction information such as there was with Seroxat.
Professor Sir Alasdair Breckenridge: Yes, I know that, but I—
Q791 John Austin: So he would have been a very key witness.
Professor Sir Alasdair Breckenridge: But I have not discussed that with Dr Hudson.
Q792 John Austin: So you must admit that it is very unfortunate he is not with us today?
Professor Sir Alasdair Breckenridge: Well, I apologise for that, but I think there was some confusion about who was going to attend and I think the Clerk was told that this was where Dr Hudson was going to be.

Why did Breckenridge reply to Q792 as he did? The email that was copied to him on Monday 17 January clearly states Lord Warner and Hinchcliffe had just agreed that it would only be Breckenridge, Woods and Raine who were appearing. For Breckenridge to say “…I think there was some confusion about who was going to attend and I think the Clerk was told that this was where Dr Hudson was going to be…” beggars belief.

Well, I think there was no confusion at all. I think the Clerk was never told that Hudson would appear. I think Breckenridge was lying when he said that. I think it would have been too embarrassing to let Ian Hudson be questioned.

I think this stinks.

Why didn’t Breckenridge simply say that “Ian Hudson is not here today because you, Mr Chairman, agreed his non-appearance with Lord Warner on Monday of this week”… (the hearing was Thursday).

And why, if Hinchcliffe did agree the list of attendees, did he say nothing to explain the confusion to the hearing….

So, the question is just what did Lord Warner say to Hinchcliffe during their phone call on the morning of Monday 17 January 2005?

Come on MHRA – let’s you and me have an open and honest discussion about this then.