Within the CSD, when the Adverse Reactions Subcommittee found strengthening evidence of a causal link between a drug and a potentially dangerous reaction, discussion would intensify, aided by consultation with all relevant levels of expertise and possibly with the manufacturer's technical experts. If the main Committee became convinced that the link was genuine, much attention was given to drafting and distributing a suitable warning. Because this would go to all doctors and would of course reach the public press, avoidance of unduly alarmist tones was important. Errors of judgment were inevitable, but I think that the CSD managed this responsibility well.
Whether for a national monitoring agency, or for the Boston hospital studies, or the type of work undertaken by the DSRU, the quality and completeness of the reports on which all inference depends requires the willing cooperation of busy men and women. From early days, I had thought that systematic feedback of information to the medical professionals who provided the raw data was essential. Individual acknowledgment of every report received was scarcely needed, but I believed that the CSD ought to have done more than it did to interact with doctors and the public (33, 34).
If we are to have a flow of therapeutic improvements by the introduction of new drugs, adverse reactions that could not have been predicted by a pharmacologist nor always observed during the routine of clinical trials will inevitably sometimes occur. I have emphasized (35) the importance of regular communication between a national monitoring agency, the drug industry, doctors, and the public, in order to increase understanding of problems that are common to all. From early in the life of the DSRU, Inman distributed to all collaborating doctors successive issues of PEM NEWS, booklets filled with information on the studies planned or in progress. I hope that today other drug monitoring operations have analogous practices of feedback.
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