Amanda Lawrence Policy Advisor & Reclassification Manager
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ	10 May 2004

 

Dear Ms Lawrence,

Thank you so much for your letter of 6^th May, saying how much you appreciated my valuable contribution to the Review of Access to the Yellow Card Scheme, and now inviting me to contribute to the Agency’s new consultation on implementation.

I think you may have written to me by mistake, but perhaps I am being unduly prickly. If so, please let me know. My reading of the situation is largely explained in the May update, at http://www.socialaudit.org.uk/6040509.htm#UPDATE

1. Dr Herxheimer and I submitted to the Review our report on paroxetine user reports (Int. J. Risk & Safety in Medicine 2002; 15, 161-169). In spite of all the fanfare about new, improved patient ADR reporting, there is no reference to that paper in the report of the Review – and even as I write, the MHRA and YellowCard websites still emphasise that medical interpretation of user reports is vital.

2. We also submitted our report on paroxetine Yellow Cards, (Int. J. Risk & Safety in Medicine, 2003, 16, 3-17), which we believe to be the only independent analysis of the working of the Scheme, but this wasn’t cited either. Meanwhile, the MHRA has dismissed our criticism as unfounded.

For these and many related reasons, I expect to be posting any comments we have on the current MHRA consultation on our website. Please get in touch if you believe I might be barking up the wrong tree.