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increase we would need 20 million patients with 20 million controls.' Again this ignores all the additional practical problems of post-marketing surveillance.3 The salutary lesson with postmarketing surveillance is that 10 000 patients are too few to detect rare adverse reactions. Professor Rawlins, like many others, chose the number arbitrarily. That postmarketing studies "are likely to be worthwhile only if they enrol 10 times the number of patients in premarket-ing trials" is no argument. "The Grand Old Duke of York, he had 10 000 men" and he found, like we will in postmarketing surveillance , that they do not achieve what is expected of them. Falsetti suggest that many women with hyper-prolactinaemia may have pituitary micro-adenomas that may become radiologically apparent over a short period of time. We find it difficult to concur fully with their conclusions because only 69% of the patients had serial sector computed tomograms from the outset. The remaining patients had sellar tomography, with its well known limitations,' which were even apparent in the current study. The concept of "radiological normality" persisted throughout the paper, often not clarifying whichi technique was being referred to; and in computed tomograms the characteristics of an important lesion were not de-fined2 3-nor were the characteristics of the de novo lesions objectively described. Seeking out those patients who progressed from a normal to an abnormal computed tomogram during the study was difficult because of the presentation of the data but they appear to constitute only six patients or 9o% of the total. In addition we also think that Dr Pontiroli and Dr Falsetti have overstated the value of stimulatory and suppressive testing. We think that these are probably not adequate for predicting which patients with hyperprolactinae-mia have a pituitary adenoma. This was apparent from their own data as more than half of the patients deemed to have a normal sella were non-responders in terms of the various tests used, and discrepancies were noted in six of 19 patients tested with more than one agent. Interpretation of the group with "normal sellas" was made even more difficult by the inclusion of seven patients with drug induced hyperprolactinaemia and an unquantified number of patients with polycystic ovaries. While we agree with evaluating the natural history of the hyperprolactinaemia in these latter two groups, we think that they should be categorised separately and not included with patients with idiopathic hyperprolactinaemia of presumptive hypothalamic pituitary …

Development of pituitary adenoma in women with hyperprolactinaemia