Bayer aspirin ads mislead the public again

The January issue of HealthFacts reported that the Bayer Corporation's petition was rejected by an FDA advisory panel. Bayer wants FDA approval so it can advertise aspirin as a heart disease preventive. Though millions of people without heart disease take daily low doses of aspirin to prevent a heart attack, Bayer is not permitted to advertise this indication until the FDA accepts convincing proof from randomized clinical trials. At this writing, the FDA has not decided whether to accept its advisory panel's recommendation; thus Bayer should not be advertising aspirin as a drug proven to prevent heart disease in all adults.

Bayer's petition was rejected in December 2003 because the cardiovascular disease experts on the FDA advisory panel came to the conclusion that the harms of aspirin therapy might outweigh the benefits for people who are at low risk of heart disease. Chief among the harms that most concerned the FDA advisory panel is the well-known risk of hemorrhagic stroke associated with chronic aspirin use--no matter how low the dose.

By early February, Bayer ads began appearing on TV. "The ads are not legitimate," according to Robert Temple, MD, of the FDA's oncologic and cardiac drug division. What's more, two of the claims made in these ads are completely false, i.e., aspirin reduces the rate of stroke and deaths from heart disease. As an over-the-counter drug, aspirin is regulated by another government agency, the Federal Trade Commission (FTC).

This is the second time that Bayer has been caught misleading the public. In 2000, the FTC determined that Bayer's ads implied that aspirin's heart attack prevention benefit is the same for all adults. The ads featured healthy young women, who as a group are at the lowest risk for a heart attack and are more likely to harmed than helped by aspirin. To settle the FTC charges, Bayer had to launch a million dollar consumer "education" campaign complete with a toll-free number. A mere slap on the wrist considering the offense.

This time around, Bayer should be required to run corrective ads, restating and then retracting as fraudulent the claims perpetuated by the current ads.