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Executive Summary

A shift in the focus of drug development studies toward more precisely defining drug uses could reduce product safety problems, Geoffrey Venning, a consultant to the drug industry in Buckinghamshire, U.K., asserted at the Drug Information Assn.'s annual meeting in Washington, D.C. June 5. Maintaining that in drug regulatory agencies around the world "the emphasis has shifted from efficacy to safety, stimulated by recent withdrawals" of drug products, Venning stated that "we should focus on benefit/risk [ratios] rather than safety . . . and shift the emphasis back to relative efficacy." By increasing the focus on the efficacy, he asserted, more accurate safety profiles would be achieved. Venning contended that "if we develop more useful drugs and establish precisely their necessary indications -- get the dose right, etc. -- we can minimize . . . potentially lethal 'type A' pharmacologically determined adverse effects." In addition, Venning asserted, with reduced "type A" adverse events, "the very, very rare 'type B' idiosyncratic problems will often prove acceptable in the context of the drug's . . . quantified benefits." Sales Reps Are More Dependable ADR Reporters Than MDs, Merck Experience Shows The British consultant was one of eight panel members asked to address the topic "Achieving International Consensus on Standards for Safety." Other panel members included representatives from drug regulatory agencies in Finland, Italy, Sweden, London, and the U.S., as well as a representative from the World Health Organization and a spokesman from Merck. Discussing the accuracy of the U.S. spontaneous adverse drug reaction (ADR) reporting system, Merck Regulatory Affairs Exec Director Kenneth Given, MD, commented that the number of ADR reports submitted to FDA on a particular drug, and any safety judgments based on those reports, are affected by the size of a company's sales force and the resulting amount of sales rep/physician contact. Maintaining that ADRs are underreported in the U.S., Given asserted that "the degree of underreporting will decrease as contracts between prescribing physicians and the mfrs. increase." The Merck exec asserted that "if you were to take two companies, one that had a large sales force with frequent physician visits, and the other a very small sales force with few, if any, physician visits, and the two companies were given the identical drug to market, the one with the large sales force would receive substantially more adverse experience reports." Given noted that in a recent sample of Merck ADR reports the company found that 58% of the reports "resulted from physician contacts with Merck professional representatives." A second variable affecting the number of submitted ADR reports, Given suggested, is the company's directions to sales reps on how to handle reports. "If reps are required to file the reports themselves, there will be less underreporting than if the company requires only that the rep leave an adverse experience report form with the physician or ask that the physician call the company headquarters," he said. Given noted that "at Merck we require our professional reps to file a report and also to leave a report with physicians to complete." Merck has found, Given said, "that in nearly 50% of the cases the physicians do not spontaneously complete and return the forms that have been left with them." Because "differences in size or procedures could lead to differences in reporting or under-reporting," Given maintained, "the size of a company's field force should be taken into consideration when evaluating reports in the spontaneous system." He noted that currently "the regulatory agency will react to the number of reports without attempting to evaluate differences between companies."

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