The Food and Drug Administration yesterday attacked as "seriously misleading" a pro-aspirin "public service announcement" that the nation's aspirin companies have helped place on television across the country.
The television spot is preceded by an announcer's voice saying, "Stay tuned for a medical bulletin on Reye's Syndrome." The ad does not point out that health officials have been warning that aspirin increases the risk of getting the potentially fatal disease if it is given to children suffering from chicken pox or the flu.
Joining FDA in its criticism of the ad were officials of the Centers for Disease Control and Dr. Edward Brandt, assistant secretary for health, who said the ad "flies in the face of scientific evidence."
The ad was prepared and distributed by a private organization called the Committee on the Care of Children. The group, which claims a membership of 1,200 pediatricians, was organized with aspirin-industry funding in 1982 shortly after federal health agencies began a public education campaign to warn parents about the link between aspirin and Reye's Syndrome.
CDC figures show that 136 children have died from Reye's Syndrome since the beginning of 1982.
The disease is fatal in about 20 percent of cases.
While the committee's ad makes no mention of aspirin, it says there is no proof that any drug causes Reye's Syndrome. FDA spokesman Bill Grigg said that while this is technically correct, "by not having a reference to a possible association between aspirin's use in chicken pox or flu and Reye's Syndrome, the committee has produced a spot that is educationally ineffective as well as incomplete and seriously misleading."
Grigg said the committee has a long record of fighting efforts to warn parents about the risk of aspirin for children with these diseases.
Last year the committee brought an unsuccessful lawsuit against the FDA to try to stop it from carrying out an educational program linking the disease to asprin.
Grigg said the committee's lawyers also have threatened legal action against television stations that broadcast FDA public service announcements. The committee has threatened drug stores that made use of voluntary warning labels on aspirin packages as well.
The committee describes itself as an organization of pediatricians. A spokesman for the American Academy of Pediatrics said the group is entirely independent of any medical organization.
"I don't know of anything quite like it," said Dr. Jean Lockhart, an academy official.
The FDA's criticism was instigated by Dr. Sidney M. Wolfe, director of the Health Research Group, who brought the committee's ad to the drug agency's attention.
Wolfe's group, a private organization founded by consumer advocate Ralph Nader, has long sought a federal regulation requiring warning labels on aspirin.
Wolfe said he has written to about 1,200 radio and television stations asking them not to use the committee's ad.
Instead, Wolfe urged the stations to broadcast more balanced announcements which the FDA is expected to mail on Thursday.
The Committee on the Care of Children is headed by Neil Chayet, a Boston lawyer who reportedly organized a similar group about 12 years ago. That organization was called the Committee on the Care of Diabetics and it fought efforts to tell diabetics that they might not need drugs to control their disease. Diet and exercise alone are capable of controlling many cases of diabetes.
Chayet could not be reached for comment, but his office referred calls to Camille Oldenburg, administrator of another Chayet organization called the International Science Exchange. Oldenburg acknowledged that the Committee on the Care of Children was launched with pharmaceutical industry funds channeled through the International Science Exchange.
One of the committee's advisory board members, however, said he had been told when the group was formed that no drug industry money was behind the effort.
"We were assured," said Dr. Robert Hoeckelman, chairman of the pediatrics department at the University of Rochester, "the aspirin industry was not behind this at all. If it is, then I think I would get out."
Asked who funded the committee, Hoeckelman replied, "The dollars are coming from some benefactors, but I'm not sure who they are."