Separate Statement of Commissioner Orson Swindle
in Sterling Drug Incorporated, Docket No. 8919

In this case, the Commission has approved a complaint and consent decree settling allegations that Bayer Corporation made unsubstantiated therapeutic benefit claims about its aspirin product in violation of a 1985 Commission order against its predecessor, Sterling Drug. Count I of the complaint alleges that Bayer made unsubstantiated claims that "regular use of Genuine Bayer Aspirin is appropriate for the prevention of heart attacks in the general adult population." The complaint identifies two unsubstantiated heart-attack-related claims allegedly conveyed by the advertisements: 1) a broad implied claim that potential heart attack prevention benefits of regular aspirin use are the same for all adults; and 2) a narrower implied claim that regular aspirin use is appropriate for heart attack prevention without risk of side effects. See   20 & 21.

Regarding the first implied claim, the complaint alleges that pre-menopausal women are less likely to benefit from regular aspirin use because they have a very low risk of heart attack compared to those persons who have had a previous heart attack. I do not believe that Bayer's advertisements, which depict young women suffering from muscle and headache pain and then state that Bayer can reduce the risk of a second heart attack by up to 50%, convey the claim that Bayer reduces heart attack risk for healthy young women. Bayer aspirin is a well-known pain reliever, and the ads' depiction of young women is clearly in connection with muscle pain (a woman lifts a bike and then grabs her shoulder) and headache pain (a woman in a noisy office puts down the phone and rubs her temple). It is not sufficiently linked with the advertisements' statements about heart attack prevention to convey the claim that regular use of Bayer aspirin is appropriate to reduce young women's heart attack risk.(1) Without additional evidence, such as a copy test, I do not find reason to believe that the advertisements convey the broad implied claim that potential heart attack prevention benefits of regular aspirin use are the same for everyone, regardless of factors such as age and sex that affect an individual's heart attack risk.

I do, however, have reason to believe that the ads convey the narrower implied claim that regular aspirin use is without side effects and is appropriate for heart attack prevention for all people who are at risk for heart attack. As alleged in the complaint, regular aspirin use has side effects for some consumers. Bayer's advertisements do not mention side effects and while they qualify the heart attack prevention claims by saying, "Just ask your doctor," this statement is ambiguous. It could imply that doctors would recommend an aspirin regimen for anyone at risk for heart attack. Thus, Bayer did not adequately convey to consumers the importance of consulting with a health care professional -- before deciding whether to begin an aspirin regimen -- to determine whether the possibly serious adverse side effects of routine aspirin use outweigh the heart attack prevention benefits for any particular individual.(2)

Although I disagree with some of the grounds underlying the complaint allegations, I approve of the remedial provisions in the consent decree. The provisions directly address Bayer's failure to convey to consumers the importance of consulting a doctor about adverse side effects before beginning an aspirin regimen and are thus reasonably related to the complaint allegations I support. Accordingly, I have voted in favor of the complaint and the consent decree.

Endnotes:

1. In addition, the complaint cites Internet materials in which Bayer states that aspirin can benefit hundreds of thousands of women a year. The Internet materials make clear, however, that Bayer is discussing the heart attack risk for middle-aged women. See  19.

2. Count II of the complaint alleges that Bayer made unsubstantiated claims that "regular use of Genuine Bayer Aspirin is appropriate for the prevention of strokes in the general adult population." As with Count I, I agree that there is reason to believe that Bayer did not adequately convey to consumers the importance of consulting with a doctor to assess side effects before starting an aspirin regimen to reduce stroke risk. However, I do not agree that there is reason to believe that Bayer conveyed the broader implied claim that the stroke prevention benefits of aspirin are the same for all adults, regardless of factors that affect an individual's stroke risk.