Professor Sir Alasdair Breckenridge CBE
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ	6 June 2004

 

Dear Sir Alasdair,

I wrote to you over a month ago, as did Dr Andrew Herxheimer, in connection with our paper on the Yellow Card system. I asked you to provide evidence for the MHRA’s assertion that our criticisms of the coding and follow-up of reports are unfounded. I received an acknowledgement to my letter of 4^th May (sent to the wrong address) but have heard nothing since.

The Code of Practice on Access to Government Information sets a target response of 20 working days but, in view of the issues at stake, I’m surprised you have waited so long.

If the MHRA is right in considering our criticisms unfounded, then we should correct any mistakes. Supporters of the Yellow Card system would expect this: our criticisms might undermine confidence in the scheme and, if unjustified, they should be withdrawn.

If we are wrong, we shall apologise and do our best to make amends – but why should we expect anything less from you and the MHRA? The MHRA has so far responded to our research only by seeking to discredit us and to undermine confidence in our competence and professionalism. Our paper was published in a peer-reviewed journal, under a distinguished editor – formerly, among many other appointments, a very senior drug regulator. A sweeping but unexplained rejection of our conclusions simply will not do.

The longer it takes the MHRA to produce the evidence, the more inclined one might be to suspect the worst. The Agency would surely be eager to correct the record, if it had the evidence to justify its denunciation of our work? Was this merely a casual, cheap and nasty jibe, or does the Agency have some substantive points in mind?

I look forward to hearing from you. If the MHRA were wrong in thinking that our criticisms are unfounded, they also seem very unlikely to do anything to correct what we found wrong. We put up the evidence to explain why we judged the operation of the Yellow Card system to be "chaotic and misconceived". Any failure to address such problems would call into question the quality of leadership in the MHRA as a whole. 

Yours sincerely,
Charles Medawar

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