The Million Dollar Question for Consumers: Aspirin Regimen Therapy - Is It Right For You?
The Bayer Corporation will launch a $1 million consumer education campaign to settle Federal Trade Commission charges that it made unsubstantiated claims in a series of aspirin ads, in violation of a previous FTC order. The Bayer ads claimed that a regular aspirin regimen is appropriate for the prevention of heart attacks and strokes in the general adult population. The FTC alleged that since some adults are less likely to benefit from a daily aspirin regime, and some may suffer adverse health effects from taking aspirin on a daily basis, the ad claims were unsubstantiated. The consumer education campaign features a brochure, "Aspirin Regimen Therapy - Is It Right For You?" that Bayer will distribute free.
Full-page print ads featured in the February through May editions of major magazines will promote a toll-free number, 1-800-332-2253, for consumers to use to obtain the brochure, and more than half a million copies will be distributed through doctors' offices. In addition to the consumer education campaign, the settlement requires that any Bayer advertising that makes claims about the benefits of regular aspirin use for prevention of heart attacks or strokes contain a disclosure that states, "Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspirin regimen."
In related cases, the Attorneys General of New York and Connecticut reached settlements with Bayer which enjoined unsubstantiated claims about the use of aspirin to prevent heart attacks and strokes and included payment of $30,000 to each state.
"This is a win-win settlement that will greatly benefit consumers," said Jodie Bernstein, Director of the FTC's Bureau of Consumer Protection. "Consumers deserve to have accurate information in advertising, especially on health issues. The consumer education material developed to settle the FTC's complaint will help alert consumers to the fact that, while some can benefit from an aspirin regimen, others may not, and all consumers should consult a doctor first."
"This education campaign will help to clear up possible confusion about the proper use and safety of aspirin in the prevention of heart attack or stroke. One of the most important messages of this campaign is the suggestion that people should talk to their doctor before taking aspirin on a regular basis. For although research has shown the value of aspirin for people who have had a heart attack or stroke, aspirin regimen therapy is not appropriate for everyone," said Dr. Claude Lenfant, Director of the National Heart, Lung, and Blood Institute (NHLBI), one of the National Institutes of Health.
As successor to Sterling Drug, Bayer is bound by a 1985 FTC order barring it from making therapeutic claims for over the counter analgesics unless it possesses competent and reliable evidence to support the claim.
The Food and Drug Administration recognizes an aspirin regimen is effective in reducing the risk of stroke or heart attacks in certain groups of people -- such as those who have had a previous ischemic (or clotting) stroke, and those who have suffered a previous heart attack or who have angina. However, regular aspirin use can, itself, cause health problems such as an increased risk of gastrointestinal bleeding and prolonged bleeding time. "The FDA has concluded that aspirin should be taken to prevent heart attacks and strokes only under the direction of a health care professional. We have therefore decided not to place information about taking aspirin for these purposes on the labels of over-the-counter aspirin products sold to consumers," said Dr. Robert Temple, Associate Director for Medical Policy at the Center for Drug Evaluation and Research at the FDA.
In its complaint, the FTC alleges that Bayer's radio, television and Internet ads claim that regular use of Bayer aspirin is appropriate therapy for the prevention of heart attacks and strokes in the general adult population. The FTC alleges that regular aspirin use has not been shown to be appropriate for prevention of heart attacks and strokes in the general adult population. For example, pre-menopausal women have a very low risk of heart attack compared to people who have had a previous heart attack or who have unstable angina pectoris. Aspirin use may help prevent clotting strokes, but will not help prevent hemorrhagic strokes. In addition, regular use of aspirin may be associated with important, adverse health effects that are not disclosed in Bayer's advertising. While some ads carried a tag line such as "Just ask your doctor," this language was inadequate to alert consumers that a medical professional should be consulted about the benefits of regular aspirin use compared to the potential risks for each individual.
The settlement bars future order violations, requires that Bayer possess and rely upon competent and reliable scientific evidence to substantiate any claims about regular aspirin use, requires the disclosure that, "Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspirin regimen," in advertising that promotes regular aspirin use for prevention of heart attacks or strokes, and requires the $1 million education campaign. As part of the education campaign, Bayer is running full-page ads with the toll-free number in Prevention, Newsweek (50+ edition), McCalls (Primetime edition), and TV Guide (Mature edition). These ads will run from February, which is "Heart Month," to May, which is "Stroke Prevention Month."
For additional information on how to be heart healthy, consumers can contact the American Heart Association at 1-800-AHA-USA1, 1-888-MY-HEART, or www.amhrt.org and the National Heart, Lung and Blood Institute at 1-301-592-8573, or www.nhlbi.nih.gov.
The Commission vote to approve the consent decree was 5-0, with Commissioner Orson Swindle issuing a separate statement. In his statement, Commissioner Swindle explained that he objected to the allegation in the complaint that the advertisements, which showed men and women of various ages, conveyed "a broad implied claim that potential heart attack prevention benefits of regular aspirin use are the same for all adults." Commissioner Swindle stated, "[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 . . . and headache pain. . . . 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." Commissioner Swindle voted in favor of the complaint and consent decree, however, because he did find 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."
The proposed consent decree was filed today by the Department of Justice at the request of the FTC. It is subject to court approval.
NOTE: This consent decree is for settlement purposes only and does not constitute an admission by the defendant of a law violation. Consent decrees have the force of law when signed by the judge.
Copies of the complaint and consent decree are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580; toll free 1-877-FTC-HELP (877-382-4357); TDD for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.
(FTC File No. D. 8919)
(Civil Action No. CV 00-132 (NHP))
Office of Public Affairs
Bureau of Consumer Protection
202-326-2989 or 202-326-3042
State of New York
State of Connecticut