Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



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.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts