Food and Drug Administration Commissioner Frank E. Young says the agency's effort to get the aspirin industry to warn consumers voluntarily about the link between the drug and a sometimes fatal disease in young people called Reye's Syndrome "looks like it is working at this point. . . . I'm convinced that jawboning the industry is probably the best way to go."
But Young said he will watch what steps the industry takes over the next two weeks before deciding whether to take further action.
Health and Human Services Secretary Margaret M. Heckler on Jan. 9 called on the industry to make voluntary warnings. Her move came after a study was released showing that children who take aspirin for chicken pox or flu appear to have a 25 times greater chance of contracting Reye's Syndrome. The government had backed off from a l982 proposal to require warnings, pending further study.
Young said that in recent weeks he and top FDA officials have met four times with aspirin-industry representatives and once with a consumer group. Further meetings are planned this week in hopes of obtaining a firm commitment from the manufacturers on their plans.
Young and other FDA officials have been most impressed with the prompt response of Plough Inc., the Memphis-based producer of St. Joseph aspirin, but are trying to get a stronger commitment from other aspirin-makers.
In a Jan. 16 letter, Young commended Plough for the "speed that you have demonstrated in halting all shipments of your aspirin-containing products . . . . Your plan for label-changes that delete the reference to the flu indication, add a warning statement for Reye Syndrome, and educate consumers of the signs of the disease represent a wise and prudent approach." He noted that these actions were taken even though the company feels that the link between aspirin and the disease has not been established.
Plough spokesman Lewis Nolan yesterday declined to say what the company is doing until its officials and FDA officials meet this week.
FDA has met twice with the Aspirin Foundation, which represents companies responsible for about 70 percent of U.S. aspirin sales (Plough is not a member). The group reportedly has agreed in principle to put warning labels on aspirin products. But Young and others said the foundation has not agreed to mention the link with Reye's Syndrome.
The foundation's executive director, Gary Goodwin, yesterday said only that further meetings this week with FDA were planned.
Young said it was his opinion that even though more studies are needed, the new study does suggest that a "link is there. . . . " He urged a voluntary effort to get the information to the public before the "flu season is over" by immediately putting warnings on supermarket and drugstore shelves.
Giant Food Inc. is taking the lead this week, by putting out signs and tear-off informational sheets in its more than l00 stores in this area.
Dr. Sidney Wolfe, head of the activist Public Citizen Health Research Group that publicized the recent aspirin study, said that in the three years since a government advisory committee warned about the link between aspirin and Reye's Syndrome, there have been at least 175 deaths among 610 cases of the rare disease reported in this country.