Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 020 7273 0763
Facsimile  020 7273 0675	.

Dear Dr Healy,

Thank you for your letter of 8 May. I am sorry you remain unsatisfied with our responses to the question of 'legal jeopardy'.

We are trying to understand what you mean by 'legal jeopardy'. It seems to us that the key to what you are referring to is in your statement 'the lawyers for companies producing SSRIs are putting pressure on judges to dismiss cases that do not demonstrate by randomised control trial methods a twofold increase in the relative risks on the SSRI compared to placebo'.

It is difficult to comment on this in the absence of a set of factual circumstances or without knowing whether or not the type of argument you mention has actually been successful. It is also difficult to see how this argument could adversely affect a participant in a clinical trial. It is fair to say that until a situation does arise where a participant in a clinical trial is adversely affected in court proceedings by his participation in a clinical trial, it is not possible to say that a state of legal jeopardy exists. The most one could say is that there is a possibility of such a state arising. The remoteness or otherwise of that possibility will depend on the circumstances in each case.

Turning to your specific questions about the Medical Dictionary for Regulatory Activities (MedDRA), this was adopted by International Conference on Harmonisation Steering Committee as the international medical terminology for regulatory activities in July 1997. It was not made available until a Maintenance and Support Services Organisation (MSSO) had been appointed (in April 99). MedDRA is now available from the MSS0 - a company called TRW - on subscription. The use of MedDRA is currently recommended in guidelines for the pharmaceutical industry. The FDA have announced intention to mandate the use of MedDRA for electronic adverse drug reporting by companies. Europe is considering mandating the use of MedDRA.

I hope you find this information useful.

Yours sincerely

Sarah Wark

Senior Scientific Assessor

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