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PROCTER & GAMBLE PLANNING REYE's SYNDROME STUDY

Executive Summary

PROCTER & GAMBLE PLANNING REYE's SYNDROME STUDY to determine whether a physician's knowledge of patient ingestion of aspirin influences the early investigation for Reye's Syndrome, P&G representative Ross Wilson stated at an Oct. 22 meeting of the Institute of Medicine's Cmte. on Reye's Syndrome and Medications. One type of study Wilson said R&G is considering involves the use of the Commission on Professional and Hospital Activities and other hospital abstracting services. "Through these groups we plan to study one of the Public Health Service areas where we will screen for all hospital discharges ]that have[ a discharge diagnosis which may be compatible with Reye's Syndrome," Wilson explained. "These selected records will then be individually reviewed for information pertinent to admission diagnosis, medication records, staging, referral and non-referral history and final diagnosis," Wilson said. "Analysis of these data should give a reasonable estimate of the effect that knowledge of aspirin ingestion has had upon the investigation of Reye's Syndrome at the early stage, whether this caused selective referral of such patients to tertiary care centers or leads to more frequent assignment of Reye's Syndrome case loads." Wilson maintained that a positive history of aspirin ingestion "can trigger the physician to suspect possible Reye's and knowing the need for intensive care" the physician may immediately transfer the child to a pediatric tertiary car center. Conversely, Wilson said, the lack of a history of aspirin ingestion can lead the pediatrician to doubt the existence of Reye's and delay referral to a pediatric center. "Both effects can lead to a preferential loading of the number of cases that appear in a pediatric tertiary care center, from where all of these eventually have to enter the study," Wilson stated. P&G, as well as representatives from the Aspirin Foundation, reiterated their criticism of the Center for Disease Control's (CDC) pilot study, conducted to assess the validity of the study methods of four case control studies by three state health centers which found an association between aspirin and Reye's Syndrome. The CDC pilot study included 29 Reye's Syndrome cases and 143 controls consisting of children admitted to the same hospital (IP) or emergency room (ER), attending the same school, or identified by random-digit dialing (RDD). CDC reported in January that of the group, 97% of case children were reported to have received salicylates during the respiratory or chickenpox illness before a clinically defined onset of Reye's Syndrome, compared with 28% (ER), 23% (IP), 59% (school), and 55% (RDD) of the controls at any time during their matched illnesses. Results of the pilot study were published in the Oct. 3 issue of the New England Journal of Medicine. Wilson recommended that an active surveillance system would be the most useful way to assure that referral bias based on medication history is minimized. In such a system, he explained, patients with certain symptoms "would be entered into the preliminary stage of the study and followed to encephalopathy stage two, at which time the parents would be interviewed." He stated: "Decisions as to which of these children had true Reye's Syndrome would be made by an independent panel blinded to the medication given. Those children identified to the panel as Reye's would become cases, those rejected by the panel as clearly non-Reye's would become controls." Wilson added that CDC has said this kind of study would be logistically difficult to complete. In addition to diagnostic referral bias, P&G's Wilson questioned the salience of parent recall, asserting that parents would search their minds for a specific instance of aspirin administration. Biometric Research Institute VP Frank Hurley maintained that the cases in the study were not representative, since 10% of the cases were under five years old. This age group, he said, was not likely to have received aspirin. In addition, he said the cases predominantly had a short duration of antecedent illness. P&G also objected to the use of the term salicylate in connection with Reye's Syndrome. Wilson said only one member of the drug class, acetyl salicylate, has been found by CDC to be associated with Reye's Syndrome.
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