Congress Probes Bayer Marketing, FDA Website with Ties to Big PharmaceuticalOct 16, 2008 | Parker Waichman LLP
The House Energy and Commerce Committee continues its investigation into direct-to-consumer advertising. As part of that investigation, the committee is looking at why Bayer Healthcare ignored U.S. Food and Drug Administration (FDA) recommendations to stop marketing a version of its aspirin that is also a dietary supplement, and why the FDA hired a public relations firm that works for the pharmaceutical industry to develop a consumer Website.
Bayer apparently promoted its Bayer Aspirin with Heart Advantage as safe and effective, despite the FDA warning it against marketing such a combination. Bayer Aspirin with Heart Advantage combines aspirin with a supplement Bayer claims can lower cholesterol.
In a letter to Bayer Healthcare president Gary Balkema, committee chairman Representative John Dingell—Democrat-Michigan—and Bart Stupak—Democrat-Michigan—who heads the House Oversight and Investigations Subcommittee, asked Bayer Healthcare to turn over all its studies indicating that its Aspirin with Heart Advantage has positive affects on cholesterol and heart disease. A separate letter was also sent to US Health and Human Services (HHS) Secretary Michael Leavitt asking the HHS how the FDA handled Bayer’s marketing of its Aspirin with Heart Advantage.
In the meantime, the committee sent a letter to FDA commissioner Andrew von Eschenbach, MD to learn more about the FDA’s decision to hire a non-profit organization called EthicAd to develop an FDA Website entitled “Be Smart About Prescription Drug Advertising: A Guide for Consumers.” The Website discusses direct-to-consumer advertising and was created as an informational guide to consumers; however, EthicAd is funded by Shaw Science Partners, which is a public relations firm that works for drug makers and helped introduce over 30 drugs, including Viagra, Celebrex, Zoloft, Abilify, and Avastin. The committee wrote Michael Shaw—of Shaw Science Partnrs—and EthicAd to learn more about their involvement. Michael Shaw is an advertising consultant to the pharmaceutical industry.
We have been reporting about studies finding that most television prescription drug ads minimize risk information. Prescription drug ads began being run on the air just over a decade ago, but a recent University of Georgia study found that most such ads do not present a fair balance of information, especially when it comes to providing information on a drug’s side effects. A research team analyzed a week’s worth of direct-to-consumer ads on broadcast and cable television and found the average 60-second ad contained less than eight seconds of side effect disclaimers, while the average 30-second ad has less than 4.4 seconds; most 15-second ads studied devoted no time at all. The team found almost all of the ads disclosed side effects solely in a voice-over portion of the ad. Only 2.2 percent of ads had the disclosure in voice-over as well as in text form.
Proponents of direct-to-consumer ads argue they help raise awareness of various medical conditions and treatments while critics argue that the ads drive up health care costs by steering consumers to costly drugs they might not need. Nielsen Media Research estimates pharmaceutical companies spent over $1.5 billion on direct-to-consumer television ads during the first half of 2007.