Dear Dr Raine,
Thank you for your email and letter of 2nd June 2011 relating to the Ativan data sheets and my assertion that Wyeth withheld information from the UK data sheets.
You state that you are unable to investigate unless you have clear documented evidence that Wyeth withheld information about dependence and withdrawal reactions. I have attached the UK 1974 and 1978 data sheets. I have also attached the 1978 Australian data sheet and the 1980 US data sheet. The Australian and U.S. data sheets provide clear documented evidence of the knowledge regarding dependence and withdrawal reactions which were in Wyeth’s possession at the time. All of these side effects and withdrawal reactions were omitted from the UK data sheets during the 1970′s and 1980′s.
You also state that with regard to “sleep disturbances” with hindsight this warning does not appear sufficient given the current knowledge of withdrawal reactions. In reality this warning was not sufficient in the 1970′s as the information was in Wyeth’s possession and clearly documented in data sheets from other countries.
You also state that data sheets were not the only source of information available to prescribers but in reality the APBI data sheet was the main source of information that doctors relied upon.
Although this occurred over thirty years ago the harmful effects of withholding this information remain today and the regulatory authority should investigate.
Yours sincerely
John Perrott
Click here to view the Ativan 1974 UK Data Sheet
Click here to view the Ativan 1978 UK Data Sheet
Click here to view the Ativan 1978 Australia Data Sheet
Click here to view the Ativan 1980 US Data Sheet