Dear Dr Raine,
Thank you for your reply of 10 August 2011.
If I may draw your attention to the core of my enquiry and the chronology of exchanges, you said you would investigate if I sent you evidence of Wyeth withholding safety data from the UK data sheet which I did, in the form of data sheets from the UK, Australia and the US, all from the same year.
Subsequently, in your last letter you supplied me with a number of imaginary scenarios giving reasons why these data sheets did not constitute evidence, for example, you say that you do not know how much information would have come from the national regulatory authority or from local sources. The answer to that would have been none, as these data sheets were the first ones. They were published the year Ativan was launched in Australia and the US.
Furthermore, you favour these possible alternative scenarios that you have created rather than the more obvious one that Wyeth withheld information.
Sleep disturbances following abrupt discontinuation remained the only warning in the UK until 1988; sixteen years after the Ativan licence application. Convulsions were not added until 1990, eighteen years following the licence application.
In Australia warnings included convulsions, tremor, abdominal and muscle cramps, vomiting, sweating, nervousness and insomnia following abrupt discontinuation
In the US warnings included convulsions, tremor, abdominal and muscle cramps, vomiting, sweating with additional warnings of anxiety, agitation, irritability, tension, insomnia plus a further list of ADRs.
Would you clarify why you are not intending to investigate this?
Yours sincerely,
John Perrott