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Liz Wager, Medical Writer Janssen-Cilag Ltd
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As a professional writer, employed by a drug company, I am always interested to see how other companies cope with the problems of acknowledging the huge numbers of people involved with complex clinical trials. The paper from Bardhan et al provides a useful example of why the ICMJE (Vancouver Group) criteria for authorship are often impossible to apply, and why the move by journals such as the BMJ towards listing contributions is to be applauded. Anyone who thinks the ICMJE criteria should be strictly applied ought to read the 'Contributors' section to understand the difficulties. It is also refreshing to see company employees featuring prominently in the list of authors.I am also pleased to see an explicit reference to the use of the CONSORT guidelines and the note about an earlier presentation of the data. I am currently working with several pharmaceutical companies to develop some guidelines on reporting clinical trials (including the thorny issue of authorship). I should be delighted to hear from people within the industry who share our aim of improving the quality of such publications and who would like to be involved with this process. |
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Mick Braddick, Clinical Epidemiologist gGroup Health Cooperative, Seattle, USA
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Dr Bardhan and colleagues are to be congratulated on their elegant study. However I suspect there may still be a role for ranitidine in the long term management of GERD. The authors did not state how many subjects in each group did not achieve symptomatic relief by the end of the first month? This data would allow calculation of the likelihood that a patient satisfactorily controlled on a given drug at one month, could be successfully managed with intermittent therapy for one year. Given the difference in cost between ranitidine and protein pump inhibitors (15 fold difference in the USA), if we could identify a sub-group of patients with GERD who could be managed with ranitidine, substantial savings could be realised. |
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Gwen Harlow, Humberside Oesophageal Support Group retired
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Sir, I refer to other recent articles in the BMJ as follows: 1998:317:1606-1607 (12 Dec)"Proton Pump Inhibitors may mask early gastric cancer" 1999:318:827 Reflux "increases risk of adenocarcinoma of oesophagus" I presume that the treatment with omeprazole is supplemented by regular endoscopy? Gwen Harlow
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George J Addis, Consultant Physician 49 Whittingehame Court, Glasgow G12 0BQ
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The evidence that the proton pump provides the energy for ATP synthesis (Nature 402,17(1999) begs the question of other effects of omeprazole. This possibility has existed since the proton pump inhibitors were introduced but this paper has not sought side effects specifically. It seems likely that there is, for example, impairment of the exercise capacity. A doubly open self-study with n=1 shows a sudden 50% improvement in endurance at maximal effort in swimming the butterfly stroke and it is just possible that the result might be true. | |||