Food and Drug Administration Commissioner Frank E. Young scolded the nation's major aspirin makers yesterday for advertising that regular use of aspirin reduces risk of first heart attacks.
Aspirin companies have touted their products' preventive value heavily in recent weeks, after a widely publicized study in The New England Journal of Medicine Jan. 28 showed that healthy men over age 40 halved their risk of heart attack by taking an aspirin every other day.
Although the study results were impressive and expected by many medical experts, all 22,000 participants were healthy physicians without the physical problems that can make regular aspirin use dangerous.
FDA officials expressed concern that the specific nature of the study was not properly described in recent advertisements.
"Most average consumers said, 'Oh boy, if I just take an aspirin every day for the rest of my life, I can avoid a heart attack,' " Young said in an interview. "But this was a study on physicians in good health. They are not the same group of people as young women or men with no history of heart disease."
Heart attacks are the nation's leading cause of death, killing more than 500,000 people annually, and the results of this study are expected to encourage millions to begin using aspirin regularly.
Participants in the study were screened to exclude persons who had trouble tolerating aspirin or had a peptic ulcer, gout, liver or kidney disease or history of heart disease.
For some people, risk of heart disease may be lower than risks of regularly taking aspirin for years. Women have a much lower rate of heart disease than men. In addition, the properties of aspirin that help thin blood also increase risk of strokes.
"We are going to analyze the data and, as soon as we do, we will make it all public," said Dr. Charles H. Hennekens, who directed the study at Harvard Medical School. "But we don't want anybody to think the risks and benefits are the same for everyone. Also, we don't want people who smoke to think they can lower their risk of a heart attack simply by taking aspirin."
In a letter to drug companies last week, Young reminded them that federal law forbids mislabeling drugs.
He said yesterday that all manufacturers have voluntarily agreed to refrain from further promotion of the study results until more specific data becomes available.