Assessing the benefit-harm balance at the bedsideBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7456.7 (Published 01 July 2004) Cite this as: BMJ 2004;329:7
All rapid responses
Loke has highlighted the importance of knowing the frequency of a side
effect of a drug (1).
In 1995 the Council for International Organisations of Medical Sciences
(2) advised that drug companies should report adverse reactions in terms
of frequency. I wrote to 120 drug companies in 1996 to see if they could
do this and the majority (45 out of 46 replies ) felt that at that time
they could not (3) I repeated my survey in 2002 and received 27 replies
from 50 letters to drug companies. Twenty one of these companies stated
that their current policy was to follow the guidelines. Seven of these
companies stated that they could provide such information for new products
only at present and would review older drugs at the time of licence
Companies that could not follow the CIOMS guidelines stated that such
information was at present unreliable due to under-reporting of adverse
drug reactions and not knowing the number of patients taking the drugs in
It appears that drug companies can now provide this information and drug
information textbooks should now request and publish this information.
1. Loke Y K Assessing the benefit-harm balance at the bedside BMJ,
Jul 2004; 329: 7 - 8.
2. Council for International Organisations of Medical Sciences. Guidelines
for preparing core clinical safety information on drugs. Geneva: CIOMS,
3. Bracchi R Drug Companies should report side effects in terms of
frequency BMJ 1996;312:442.
Competing interests: No competing interests