Here is an abbreviated chronology of the Reye's syndrome-aspirin controversy:
- Jan. 14, 1982: Three hours before the American Academy of Pediatrics' monthly newsletter was to go to press, three representatives of Schering-Plough Inc. showed up in the office of Dr. M. Harry Jennison, then the Academy's executive director.
Schering-Plough, maker of orange-flavored St. Joseph's Aspirin for Children, was concerned about one newsletter item that alerted pediatricians to the suspected risk of Reye's posed by giving aspirin to children with chicken pox or the flu.
Jennison remembers the meeting vividly:
"They wanted to make it very clear that if (newsletter) went out, we would face a very serious lawsuit," he said.
Jennison pulled the Reye's item, but he sent a special advisory in the next month's newsletter. The academy's Committee on Infectious Diseases in June recommended that warning labels be required on all aspirin bottles.
- March 12, 1982: Schering-Plough sent its own letter to thousands of pediatricians, advising that "there is no valid scientific data" directly linking aspirin and Reye's. "Therefore," the company said, "you should feel confident in continuing to recommend aspirin for the reduction of fever in children."
- June 4, 1982: U.S. Health and Human Services Secretary Richard S. Schweiker said that available evidence justified requiring warnings on all bottles of aspirin products. The Aspirin Foundation of America began an intense lobbying effort to convince him otherwise.
By order of President Reagan, all new regulations had to be evaluated for cost-effectiveness by the White House Office of Management and Budget. So Dr. Joseph White, president of the aspirin group, arranged to meet with James J. Tozzi, then an OMB official.
Tozzi said he checked the aspirin lobby's complaint with an outside scientific expert and then told the Food and Drug Administration: "You have not made your case."
"Procedurally, it was the best decision I ever made," Tozzi said recently. He now directs a Washington-based consulting firm that specializes in companies seeking regulatory relief.
- Nov. 18, 1982: Schweiker retracted his proposal, calling the idea of warning labels premature.
- Oct. 7, 1983: Government and Aspirin Foundation officials met to discuss 470,000 educational pamphlets the FDA was about to distribute to 4,200 supermarkets nationwide. After the meeting, the pamphlets, which cost $18,000 to produce, were stashed in a warehouse. They have since been destroyed.
Within a month, the FDA had produced a new pamphlet, but with significant changes.
Of the statistical link between Reye's and aspirin, the original pamphlet said: "Many medical experts . . . agree this apparent relationship cannot be ignored." The revised version read: "The validity of these studies has been questioned by some experts."
The original cautioned that "in most cases, it is unwise to give aspirin to a child with viral illness, and it is also unnecessary." To the question of whether parents should avoid giving aspirin to children with flu symptoms, the revised answer began: "Not necessarily."
- Fall, 1983: The Committee for the Care of Children, an industry-paid group of pediatricians, sent an attorney's letter to broadcasters nationwide, asking them not to run the FDA's public service announcements on Reye's. Any station that did air the spots would be required to give the doctors' group equal rebuttal time under the "Fairness Doctrine of Federal Law," the letter said.
The announcements were not widely used.
- Nov. 5, 1984: Public service announcements produced by the committee were lambasted as "seriously misleading" by several government health agencies. The "medical bulletin on Reye's syndrome" did not mention aspirin, but advised: "We do know that no medication has been proven to cause Reye's."
A supermarket pamphlet produced by the group did mention aspirin, under the caption: "Myths about R.S."
"Recent studies suggest an association between aspirin and Reye's, especially in children with influenza or chicken pox," the pamphlet said. "We believe, and most authorities now agree, that these studies cannot be interpreted in this way. All medical experts agreed that aspirin does not cause R.S."
- Jan. 9, 1985: HHS Secretary Margaret Heckler, citing preliminary data from a Public Health Service study, asked all aspirin manufacturers to begin using warning labels voluntarily.
Several independent aspirin makers, including Schering-Plough, acted promptly and decisively to place warning stickers on packages, and changed labels to feature the association between Reye's and aspirin.
The eight large aspirin suppliers of the Aspirin Foundation did not re-label all their products until the end of August. Their new labels only suggested that parents to consult a doctor before giving the product to children.