Mind calls for external investigation into approval of medicines following revelations of insider dealings

Posted Monday 4 October 2004

In the light of revelations reported in The Guardian, leading mental health charity Mind has today written to Lord Warner, the minister responsible for UK medicines regulation. The charity is demanding an immediate criminal investigation into the role of a former senior member of the Committee on Safety for Medicines (CSM) in the licensing of the antidepressant Sertraline, brand name Lustral.

Today's Guardian reveals an internal memo obtained by Mind from Pfizer, indicating that the individual, also a prominent psychiatrist, had offered to become a paid adviser to the drugs company prior to Lustral receiving regulatory approval. Mind is sending the memo to the minister along with the letter from Richard Brook.

The charity also called upon the Government to conduct an urgent, full, independent and open review of the entire UK drug regulatory system, stressing that an internal MHRA investigation would inevitably be compromised by a conflict of interests. The Guardian allegations follow a controversial BBC Panorama programme, broadcast Sunday 3 October 2004, in which the Medicines and Healthcare Regulatory Agency (MHRA) faced heavy criticism over the way in which it regulates and licenses medicines in the UK.

Speaking today, Mind's Chief Executive, Richard Brook, said:

"Today's revelations yet again cast doubt over the MHRA's supposed independent regulatory role.  They also throw doubt on the impartiality of evidence supplied to it by a particular individual who played a key role in the clinical trials that led to the eventual licensing of Seroxat. We now must seriously question whether the MHRA system can really be trusted to put consumers' interests first."

"There can now be little doubt that there are fatal flaws in the way that medicines are licensed in the UK, the implications of which may have even put patients lives at risk. The public needs to have confidence that the drugs we are prescribed are both safe and effective, but the current regulatory system does little to ensure either."

"Antidepressants can undoubtedly provide a lifeline for many thousands of people experiencing depression, particularly when used together with talking treatments like counselling or therapy. But the public needs to feel that confident that these drugs are tested thoroughly, regulated properly and prescribed appropriately. It is increasingly clear that the current system of drugs regulation is failing the British public on all three counts."

Anyone with concerns about their medication should contact their doctor before taking any further course of action. Do not stop or change medication without medical advice.

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