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Executive Summary

PHS' REYE's SYNDROME STUDY TERMINOLOGY SHOULD SPECIFY aspirin alone as the agent being investigated for its possible link to the disease, the Institute of Medicine (IoM) said in its Dec. 24 report. The report states that "because there is insufficient information on the effects of salicylates in general in this study . . . the association should be presented as a relationship with aspirin." The report is the fifth of a series prepared by IoM's Cmte. on Reye's Syndrome and Medication Use, which is evaluating the methodology employed by the Public Health Service Task Force epidemiology study, a pilot study which precedes a full-scale epidemiological study on aspirin and Reye's Syndrome. Noting that "concern has been expressed that the Task Force investigators' description of an association of 'salicylates' and RS is incorrect and misleading," IoM said "the committee concurs with this criticism, and suggests that the investigators use more precise language in future communications." FDA's proposed rule for a Reye's Syndrome warning statement applies only to aspirin-containing products. The proposed reg, published in the Dec. 17 Federal Register, requires "orally administered over-the-counter, aspirin-containing products" to carry the statement: "Warning: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's Syndrome, a rare but serious illness" ("The Pink Sheet" Dec. 23, In Brief). IoM's report focuses on the concerns raised about PHS' pilot study results at an Oct. 22 public meeting between PHS task force investigators, IoM, and representatives from the aspirin industry. Noting that one "concern raised was the possibility that knowledge of medication use during the prodromal illness, specifically a history of aspirin use, might have influenced physicians' decisions to refer RS cases to pediatric tertiary care centers," IoM commented that "while referral bias cannot be discounted necessarily, a possible referral bias is unlikely to have accounted for the associations reported from the pilot study." The report explains that "the basis for this conclusion is that generally in cases of Stage II and greater RS (the study was restricted to cases of that severity) patient referral is most strongly influenced by the severity of the presenting symptoms." The report notes that another concern raised was that "the apparent underrepresentation of children younger than 5, as compared with age distributions of case series reported previously in the literature, ]might] skew the case group toward RS patients likely to have used aspirin, because non-aspirin liquid antipyretics are commonly administered to young children." Responding to this, IoM stated that "the age-matched comparisons of RS cases and controls are valid and do demonstrate an association with aspirin." The report points out "an epidemiologic study need not include study subjects representative of all age, race, or other strata to provide valid findings."

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