A CALL FOR 'GLASNOST'

"The difficulty for licensing authorities is not so much that of balancing the risks and benefits of a new medicine, but that of communicating them to all interested parties without breach of commercial confidentiality and within the legal framework governing that regulatory body. Industry and regulators should never use the cloak of commercial confidentiality to escape public accountability. The more information that can be passed on to doctors and patients and the public without infringement of confidentiality agreements the better. This must be the guiding principle for industry and regulatory bodies alike"

tHE DIFFICULTY FOR LICENSING AUTHORITIES IS NOT SO MUCH THAT OF BALANCING THE RISKS AND BENEFITS OF A NEW MEDICINE, BUT THAT OF COMMUNICATING THEM TO ALL INTERESTED

* This discrepancy was queried in a letter (23 July 1997) from Social Audit to the CSM/MCA.. After a reminder, they replied (15 Sept 1997) as follows: "Your question highlights an error on our part in the presentation of the results of the survey. Doctors were invited to categorise the reaction as 'mild', 'moderate' (not 'moderately severe') or 'severe' ... The conclusion is therefore consistent with the findings for the majority of patients."

Comment: Exactly as many patients experienced withdrawal symptoms that were 'severe' as were 'mild' - with most suffering something in between. To have concluded on this basis that "the withdrawal symptoms observed do not appear to be severe" and that, "the study suggests that they are relatively mild", still seems to misrepresent/discount significant numbers of patients' experiences and reporting doctors' views, also to raise doubts about the quality of the peer review process in the British Journal of Clinical Pharmacology - CM.