Let down by the MHRA… again

This from Paul Flynn MP:

We have not been properly protected against bad medicines. The regulator the MHRA failed to do their job.

An article in the BMJ today concludes that ” The Medicines and Healthcare products Regulatory Agency’s announcement, 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.”

The article referred to is entitled Seroxat and the suppression of clinical trial data:regulatory failure and the uses of legal ambiguity.

The abstract reads:
“This article critically evaluates the Medicines and Healthcare products Regulatory Agency’s announcement, 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. This article assesses the existence of significant gaps in the duty of candour which had been assumed to exist between drugs companies and the regulator, and reflects upon what this episode tells us about the robustness, or otherwise, of the UK’s regulation of medicines.”

The article continues:
“It seems unarguable, then, that for five years, GSK deliberately failed to disclose clinical trial data which provided evidence that Seroxat should not be prescribed to under-18s. Given that, in 1999 alone, 32 000 prescriptions for Seroxat had been issued to children in the UK, it is clear that in the time-lag between the completion of the relevant clinical trials (1998) and the CSM’s warning notices (2003), tens of thousands of under- 18s were prescribed a drug that was unlikely to work, and which carried an unacceptable risk of a serious, indeed fatal, adverse reaction. We do not know how many, if any, under-18s actually committed suicide between 1998 and 2003 as a result of taking Seroxat, but given the large number of children involved, it is certainly possible that deaths occurred which could have been avoided by prompt disclosure of this information.”

You can download a PDF of the entire article here.

The conclusion reads:
The MHRA CEO, Kent Woods wrote “… to the CEO of GSK, Jean Pierre Garnier, informing him of the decision not to proceed to prosecution, suggests that a strengthening of the law ‘‘should be unnecessary in an industry which relies so heavily on public trust and aspires to high ethical standards’’.28 The ‘‘moral responsibility’’ to provide data, Woods goes on to say, ‘‘now needs to be insisted upon by the unambiguous force of law’’ (emphasis added).

Deftly, therefore, Woods criticises GSK for failing to meet their moral responsibilities, and the law for being too ambiguous. GSK has avoided prosecution, and the MHRA has avoided the intense negative scrutiny which would have been the inevitable consequence of a criminal prosecution.

For both, then, could this almost be a win-win situation, four and half years in the making?“