FDA Urges Caution in Aspirin Use
The commissioner and two other top officials of the U.S. Food and Drug Administration have urged doctors to use the utmost care in advising patients to take routine doses of aspirin to prevent heart attacks.
The cautionary message, the latest development in the debate on aspirin as a heart attack preventive, appeared in today’s issue of the Journal of the American Medical Assn. Publication of the essay comes four months after a team of Harvard University researchers published a report in January concluding that regular aspirin doses lowered heart attack rates among 11,000 male American doctors.
Conclusions Not Definitive
Today’s commentary, emphasizing the preliminary nature of the January findings, urges doctors to be extremely guarded in advice they give their patients about aspirin use. It said that the Harvard data--which evaluated aspirin and heart attack incidence--can’t yield definitive conclusions about whether aspirin improves mortality until after the year 2000.
The essay--by Dr. Frank Young, the FDA commissioner, and Drs. Stuart Nightingale and Robert Temple--concludes that mass media coverage overplayed the supposed benefit of aspirin and deemphasized findings that the incidence of stroke, and sudden death as a whole, was higher in the doctors who took aspirin.
“If used, aspirin should be considered a possible adjunct, but not an alternative, to risk-factor management,” Young cautioned, “which includes smoking cessation, cholesterol-level lowering and blood pressure reduction.”
The January study, which was accompanied by major advertising and promotion campaigns by aspirin makers, resulted in the AMA, the FDA and individual physicians’ offices being inundated by inquiries from patients and the general public. In early March, the FDA asked aspirin manufacturers to halt advertising claiming heart attack benefits.
Young noted that the Harvard research subjects--all age 40 to 84--may have been far more adept at detecting potentially dangerous aspirin side effects than people outside the medical profession. He said it is likely they are in better overall health than the population at large.
Officials’ Conclusions Told
The three FDA officials also concluded that:
--The aspirin study’s conclusions necessitate intensive additional review because the overall heart attack rate for the doctors studied--including those who took aspirin and those who did not--was far lower than in the population at large, raising the possibility that the doctors may not be a truly representative study group.
--Conclusions about whether the aspirin group would have longer life spans overall may not be possible until after the year 2000. The Harvard researchers had attempted to emphasize this point in press briefings at the time the study was released.
--Even taking into account just what occurred in the study group during the research project, death rates were identical in the aspirin and non-aspirin groups, even though the heart attack rates for the aspirin takers were lower.
--There was a small but higher rate of certain types of strokes (caused by bleeding in the brain) among doctors taking aspirin compared to those who did not. “This is not an unexpected finding,” Young noted, because one of aspirin’s principal actions is to inhibit formation of platelets--disc-shaped blood cells that facilitate clotting.
Depends on Patient
“The lack of any trend toward net survival benefit must be noted as a concern,” the Young essay concluded. “If there is a 47% reduction in (serious heart attacks) and an increase in serious intracranial hemorrhage (a type of stroke), whether a particular patient will gain or lose depends on his or her base line risk for those events.”
Young said physicians can probably be assumed to be more aware of the need to control their blood pressure and that a more disparate group of people might include many with hypertension in whom aspirin-related stroke risk could be significantly increased and go undetected.
Young said the FDA expects a formal petition from manufacturers to change what is called the labeling for aspirin so it is recommended as a heart attack preventive for all people. Labeling, in this case, means government-authorized directions to physicians, not package directions. Young said the agency will give the manufacturers’ request a “high priority,” but researchers who conducted the original research said they do not expect analysis final enough to permit a decision by the FDA before fall.
Researchers Agree
In Boston, Julie Buring, one of the lead investigators in the study, said she and the other researchers were “100%, absolutely” in agreement with the pointedly conservative, cautious tone of Young’s message to physicians.
“I think any time you have such a readily available agent that could have so much potential for benefit that, of course, people are going to be interested,” Buring said.
Dr. Bruce Dan, a senior editor of the medical journal, said the essay by the three FDA officials apparently represents the first time a top federal health official has used the journal as a forum to make such an urgent plea for caution.
“It is pretty unique,” Dan said. “I think it was probably a very forceful way . . . for the FDA to be able to give some sort of comment about a situation in which physicians were confronted with overwhelming media publicity and thousands of patients asking them what they should do.”
Dr. Eugene Fishman, a Century City internal medicine specialist, said his office had received several hundred inquiries from patients about aspirin-taking since the Harvard study results were published. He said that, after careful interrogation to determine possible aspirin side effect dangers, he advises patients they may safely take one child’s aspirin a day--1.5 grains. The dose is less than half of a full adult-strength tablet.
