Absorption of irrigating fluid during transcervical resection of endometrium

Abstract

Promotion by the British pharmaceutical industry SIR, -As pharmaceutical physicians in a company that has not been mentioned in complaints to the Association of the British Pharmaceutical Industry (ABPI) we were interested in the paper by Drs Andrew Herxheimer and Joe Collier on promotion by the British pharmaceutical industry. ' Breach of the ABPI code or the Medicines Act cannot be condoned under any circumstances. We find it difficult, however, to interpret the data in the paper and do not understand how the authors reached their conclusions. We cannot tell whether a large or small proportion of all the promotional materials in the United Kingdom are in breach of the act and whether the ABPI has been diligent in detecting 100 breaches per year or whether the problem is much more widespread. How wide is the ABPI's spontaneous audit? Numerators have been identified, but not denominators. The paper contains unproved assumptions such as "we estimate in round numbers that 600 breaches were detected in six years" and "it is assumed that the incidence of breaches did not change between 1972 and 1988." Such methods for deriving conclusions would not usually pass scientific peer review. An independent audit for comparison with these data would help to investigate whether the ABPI code is being enforced more vigorously than the Medicines Act.We do not know of any data to support the hearsay quote of a Food and Drug Administration official that "the vast majority of promotional materials submitted for consideration to the FDA are false or misleading in some respect" or that the administration takes regulatory action in 5% of cases. The interpretation of this statement requires a definition of the conditions under which the materials are submitted: Were they complaints or routine audit? How can we tell whether the system in the United Kingdom is better or worse than that in the United States?There are no data in this paper that suggest that a different type of regulation would be more effective. In particular, the general public and members of the health professions may not be qualified to judge whether materials are misleading. Independent specialists in the field may be the best judges. This paper will probably be widely cited, but it is hard to interpret without suitable comparative groups. BrMedJ 1990;300:307-11. (3 Februarv.) AUTHORS' REPLY, -Drs A W Fox and J E Gait say that they do not understand how we reached our conclusions but do not say which conclusions they mean. Our study is essentially descriptive and based on published information that anyone can check. We also cannot tell what proportion of the promotional materials in the United Kingdom breaches the ABPI code or the Medicines Act and therefore could make no statement about the diligence of the ABPI. If they want to know how wide the ABPI's "spontaneous audit" is then they must ask the ABPI, not us.Our estimate that around 600 breaches were detected in six years derives from the data we gave: 379 breaches were detected by the committee and 158 or m...