Glaxo & the MHRA; the MHRA & Glaxo…

I’ve always questioned exactly where big pharma ends and the regulators begin.

Certainly the MHRA (the UK’s medicines watchdog) has always had VERY close ties to the drug industry, and I mean VERY close.

The revolving door that connects the MHRA and GlaxoSmithKline (in particular) has always been well used.

The Chairman of the MHRA, Alasdair Breckenridge, is a former employee of GSK (then known as SmithKline Beecham), as is the Head of Licensing at the MHRA, Dr. Ian Hudson.

Breckenridge has a track record of publically supporting Seroxat (but not really very well!)… Hudson is much more interesting – he 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 actually used him as one of their defence witnesses in the famous Tobin/Schell case (he gave evidence for Glaxo alongside David Wheadon). And to this day we still don’t know if Wheadon was guilty of perjury in that court.

However by 2005, Hudson was not so keen on talking…

A 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.

A prior engagement!? Hudson is the one man who knows more about Seroxat’s secrets than anyone outside of GlaxoSmithKline.

A prior engagement? – don’t make me laugh, Ian.

Now, in 2010 we see more evidence of the revolving door between the MHRA and Glaxo in the company’s choice of expert witnesses to appear in the High Court.

The tireless Bob Fiddaman at Seroxat Sufferers has discovered some very interesting facts about Glaxo’s expert witnesses.

One is Dr. Rashmi Shah is the owner of Rashmi Shah Consultancy Ltd. Shah was employed by the MHRA between 1987 and 2004. Positions held were: Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.

I would be very interested to know 1): who are the current clients of Rashmi Shah Consultancy Ltd and 2): which company was its first client back in 2004…

I’d put money on the answers being – 1): GlaxoSmithKline and 2): GlaxoSmithKline

But this is only the start – Bob Fiddaman is promising revalations about other Glaxo ‘expert witnesses’ in the near future – keep on checking back at Seroxat Sufferers.

You want more evidence of the cosy relationship between the MHRA and Glaxo?

What happened when the MHRA found that Glaxo had hidden negative trial data?… The MHRA announced, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear.”

You want more evidence of the cosy relationship between the MHRA and Glaxo?

How about MHRA staff co-operate with Glaxo to monitor critical comment on the internet..

One Response to “Glaxo & the MHRA; the MHRA & Glaxo…”


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