Where do we go from here?

So, where do we go from here?

My thanks to Charles Medawar of Social Audit for this summing up:

In the immediate future, there is potential for progress on three main fronts – none politically attractive, though all central to the future health and reputation of pharmaceutical medicine.

First, we need urgently to examine the meaning of personal responsibility in corporate settings: specifically, the General Medical Council (GMC) should now investigate and rule on the conduct of Dr Alastair Benbow. Both would in some way be on trial. The GMC is a professional court with feudal if honourable traditions, with still some way to catch up with the climate of the late 20th century. As for Dr. Benbow, he seemed so sincere in his advocacy for the drug, so replete with reassurance, that his position must now be clarified. Did he critically review the relevant scientific evidence before making these claims? Was he a leader in some cynical process, or kept well ignorant and brilliantly coached in his denials? The latter seems much more probable, but we need to know for sure. Are these horrible and damaging drug disasters driven by knaves, fools, or victims – or some, none or all of the above? The GMC must now rise to the occasion: we need some definitive view.

Secondly, what of the proposed prosecution of GlaxoSmithKline by the UK authorities (led by the Medicines and Healthcare products Regulatory Agency)? In the USA, civil actions will progress later this year, seeking to link the now damning factual evidence with tragic human consequences. But in Britain, are we now due for a replay of Prime Minister Blair’s recent decision to abort the bribery investigation into British Aerospace (BAE), on the grounds of national interest and security? What is the MHRA up to? Their last word (7 April 2006) was this: “The conduct of the investigation required the Enforcement Division of the MHRA to consider over a million pages of scientific and other documentation which comprised the factual background to the case. A team of medics and scientists from across the MHRA assisted with this. The process of considering documents is now completed and documents are only reviewed now if they come to light as new evidence. Potential witnesses from inside the MHRA have been interviewed and notes have been taken from them, from which statements will be drafted. These statements seek to convert the findings of the review of the scientific and regulatory documentation in to evidence suitable for the conduct of a criminal trial, if appropriate … once the criminal investigation has been concluded a file will be forwarded to prosecuting lawyers within the legal department of the Department of Health. They will apply the Code for Crown Prosecutors to decide whether or not there will be a prosecution.”

Thirdly, we urgently need some proper enquiry into the conduct and effectiveness of the UK drug regulators themselves – the Medicines and Healthcare products Regulatory Agency (MHRA) – in line with the 2005 recommendations of the Parliamentary Health Committee, in its report on ‘The Influence of the Pharmaceutical Industry’. The evidence from this and earlier Panorama programmes hugely underlines the importance of this main recommendation: “During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust. Nor did we conclude that the MHRA provides the discipline and leadership that this powerful industry needs. We recommend that there be an independent review of the MHRA …”

Oh yes – and we also go to the High Court taking Glaxo with us.

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