New Study Strongly Links Aspirin, Reye’s Syndrome

A new federal study has found such a strong association between the use of aspirin in children and the often-fatal Reye’s Syndrome that scientists are expected to call for an immediate warning against the drug’s use on ill youngsters.

The still-unpublished pilot study conducted by the federal Centers for Disease Control found that children suffering from flu or chicken pox were 12 to 25 times more likely to develop the disease when given aspirin than were sick children who did not take the drug.

An official of the Department of Health and Human Services involved in the debate over aspirin’s link to Reye’s Syndrome said Tuesday that data from the study were “so overwhelming” that members of the quasi-governmental Institute of Medicine are expected to recommend that preventive action be taken before the full study is completed.

“This is the end” of the debate over aspirin and Reye’s Syndrome, contended the official, who spoke on condition he not be identified. “The data are really convincing.”

The HHS official said he expected the FDA to require some kind of labeling change. “If nothing else, you’ve got to get rid of the label right now that recommends the use of aspirin for flu,” he said.

The official also said that the study, which is being reviewed by the institute, indicates for the first time that teen-agers are at risk from Reye’s Syndrome. The institute is a part of the National Academy of Sciences.

Reye’s Syndrome is characterized by the sudden onset of vomiting, often with fever and sometimes accompanied by lethargy, severe headaches and changes in behavior. It can progress quickly to convulsions, delirium and coma and is fatal 20% to 30% of the time.

Drug industry officials, who have accused the federal Food and Drug Administration of unfairly impugning the safety of aspirin, contended Tuesday that the CDC study was incomplete and its findings inconclusive.

Terry Kelley, a spokesman for Sterling Drug Inc., manufacturer of Bayer aspirin, said the pilot study “was designed only to assist in determination of the methods to be used in the ongoing study, not the drug/disease relationships.”

And Neil Chayet, a spokesman for the Committee for the Care of Children, an organization originally funded by the aspirin industry, said the premature release of the study “is deeply resented by those who believe in science and fairness.”

Report to Be Released

A spokesman for the National Academy of Sciences confirmed that the Institute of Medicine has reviewed the pilot study and is expected to release its report shortly, but she refused to comment.

Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, which disclosed the CDC study Tuesday, demanded that the FDA seize children’s aspirin from store shelves or require that the products carry emergency warning stickers.

In a letter to Dr. Frank Young, an FDA commissioner, Wolfe called the study results an “extraordinarily high risk ratio.”

Wolfe said that no association has been demonstrated between Reye’s Syndrome and the use of acetaminophen, the active ingredient in non-aspirin pain relievers. “If a child’s temperature is low, you don’t have to give anything,” he said.

Wants Parents ‘Aware’

Health and Human Services Secretary Margaret M. Heckler “very much wants parents to be aware of the results of the study,” spokesman Claire del Real said. But the spokesman added that, although the study “strongly suggests a link” between aspirin and Reye’s Syndrome, it included too few cases to let the government “do any more than we have done”--warn parents that there may be a connection.

The CDC study compared 29 children who developed Reye’s Syndrome after suffering from chicken pox or flu with 143 sick children who did not develop the disease. Ninety-six percent of the Reye’s Syndrome children had been given aspirin, compared with 45% of the control group.

HHS announced in June, 1982, that it would require labels on aspirin warning against their use for childhood diseases. But it withdrew the proposal after the drug industry waged a campaign against the labels.

More recently, the HHS took the unusual step of denouncing as misleading public service television announcements by the Committee on the Care of Children that said “no medication has been proven to cause Reye’s.”