Standing in line at the drugstore the other day, I noticed a cardboard rack filled with boxes of Bayer aspirin. Each box of 100 regular-strength tablets was shrink-wrapped with a free box of 30 low-strength "Aspirin Regimen" tablets.
Even without reading the box, everyone passing the rack presumably knew what the standard tablets were for: relief of aches, pains, and fever. But I'm sure many did not know what the low-dose version was for–even if they read the box.
"For the temporary relief of minor aches and pains or as recommended by your doctor," says the label, which cautions that "because of its delayed action" the "enteric safety coated" 81-milligram aspirin "will not provide fast relief of headaches, fever or other symptoms." Then why would anyone buy it? "Ask your doctor about new uses," the box mysteriously suggests.
If that seems maddeningly vague, don't blame Bayer. Blame the Food and Drug Administration. The "Aspirin Regimen" tablets are intended to help prevent heart attacks and stroke, but the FDA won't let Bayer say so on the label. The agency doesn't want manufacturers to openly promote aspirin as a tool for fighting cardiovascular disease, despite decades of research showing it's effective for that purpose.
Charles Hennekens of the Harvard Medical School, a leading researcher in this area, sums up the evidence this way: "Aspirin clearly reduces by 15 to 30 percent the chances that men or women who have already had any 'vascular event' (e.g., a heart attack, stroke, angina, or other clot-caused circulatory problem) will suffer or die from a subsequent one….In both men and women, taking aspirin within 24 hours of a heart attack can reduce deaths by 25 percent and also reduce later heart attacks or strokes by almost half. In terms of prevention, low-dose aspirin reduces the risk of having a first heart attack by about one third in men between the ages of 40 and 84."
Thousands of Americans die every year because this information is not adequately disseminated and applied. "When it comes to treating people with cardiovascular disease or those who are in the midst of a heart attack," writes Hennekens, "we need to be using aspirin more often." He estimates that one-fifth to one-half of people in those categories do not take aspirin.
Yet the FDA has only grudgingly permitted companies like Bayer to publicize aspirin's life-saving potential. In 1980, the agency began allowing manufacturers to tell physicians that aspirin reduces the risk of a stroke after a transient ischemic attack (a "mini-stroke"). In 1985, it said doctors could be informed that aspirin is useful in preventing a second heart attack.
Since 1988, when Hennekens and his colleagues reported that aspirin can also prevent first heart attacks, the FDA has been considering whether to permit instructions about this application in labeling for doctors. And someday, it may let manufacturers tell physicians that an aspirin can save a patient's life during a heart attack.
But none of this information is permitted on the labels you and I see in the drugstore. In explaining why, the FDA notes that the benefits of aspirin have been demonstrated only for certain groups and that taking the drug over an extended period of time sometimes causes serious side effects. The agency worries that people will treat themselves instead of consulting a doctor, or substitute an aspirin regimen for important lifestyle changes.
In other words, the FDA doesn't trust us with the truth. Tellingly, the only reference to heart disease that the agency has considered allowing on aspirin labels takes the form of a warning: "IMPORTANT: See your doctor before taking this product for your heart or for other new uses of aspirin, because serious side effects could occur with self-treatment."
There are ways to get around the FDA's control over labeling. In recent years Bayer has run TV commercials that discuss heart attack prevention, and the display I saw at the drugstore included a pamphlet, "Myths and Facts About Aspirin," that repeatedly raises the topic in a circumspect way. The display itself announced, in tiny print, that "Bayer Aspirin and the American Heart Association are united in the fight against heart disease and stroke." Inside the box of regular aspirin was a copy of the AHA's "Heart Health Appraisal." Hint, hint.
"You have to be careful," says Sheryl Dennis, a Bayer consumer relations representative. It's enough to make you reach for the aspirin.
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