The early recognition of serious adverse effects of drugs is clearly important for ensuring optimum health care. Since only about 3000 patients will receive a new drug prior to licensing, it is essential that systems exist to monitor their safety thereafter. Within the United Kingdom, the corner-stone of this post-marketing surveillance has been the yellow card system of reporting adverse drug reactions to the Committee on Safety of Medicines. Now over 25 years old, this mechanism is generally highly successful, even though underreporting is known to occur. In reviewing the future requirements for adverse drug reaction monitoring (in the aftermath of the Opren affair), the Second report of the Working Party on Adverse Drug Reactions [1] concluded that there was a need for other independent systems to monitor new drugs, although they recognized the difficulty of creating, maintaining and funding such enterprises. Apart from Prescription Event Monitoring [2], no other system has been developed in this country. The ideal resource should not only be able to detect adverse reactions with new drugs but also to examine specific drug toxicity issues that arise. Such an issue, raised initially on the theoretical grounds that a reduction in intragastric acidity increases nitrosamines [3], is whether taking the H2-receptor antagonist, cimetidine, might result in the development of gastric cancer. Initially a sharp reduction in the sales of the drug followed this suggestion but today, 10 years later, H2-receptor antagonists, including cimetidine, are amongst the most commonly prescribed drugs. Actual data on the cancer risk have been difficult to obtain but in this issue, Dr ColinJones and a team of distinguished investigators report the results of an ad hoc postmarketing surveillance study of cimetidine which started in 1978. Their paper deals specifically with the incidence of carcinoma of the stomach and oesophagus in a cohort of 9928 patients for whom cimetidine was prescribed 10 years earlier. They conclude that there is no evidence for a link between cimetidine therapy and the subsequent occurrence of gastric carcinoma. However, they did find a small rise in oesophageal cancer deaths in years 7 and 8. What confidence can we take from this result? The question of statistical power needs to be considered. Adverse drug reactions are more difficult when the supposed toxicity already occurs spontaneously in the population. In 1988, stomach and oesophageal malignancy ranked as the third and seventh most common causes of cancer death. [4].Thus if the expected background incidence of deaths from gastric carcinoma is four deaths per 10 000 persons per year (as quoted), a similar cohort of 35 500 patients would need to be studied [5] to exclude a doubling in the incidence of gastric
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