As part of its ongoing investigation into direct-to-consumer advertising, the House Energy & Commerce Committee is exploring two new lines of inquiry - why Bayer ignored FDA recommendations to refrain from marketing a version of its aspirin that is also a dietary supplement, and why the FDA hired a public relations firm that works for pharma to develop a consumer web site.
The committee wants to know why Bayer promoted its Bayer Aspirin with Heart Advantage as safe and effective, when the FDA had warned against marketing such a combo. The tablet combines aspirin with a supplement Bayer claims can lower cholesterol. The FDA, however, only regulates the drug.
In a letter to Bayer Healthcare prez Gary Balkema, committee chairman John Dingell and Bart Stupak, who heads the Oversight and Investigations Subcommittee, asked Bayer to turn over all studies that show Aspirin with Heart Advantage has positive affects on cholesterol and heart disease. A separate letter was sent to US Health & Human Services Secretary Mike Leavitt to ask what, if anything, the FDA did about Bayer's marketing.
Meanwhile, the committee also sent a letter to FDA commish Andy von Eschenbach to learn more about the FDA decision to hire a non-profit organization called EthicAd to develop an FDA web site about DTC ads. EthicAd, you may recall, is funded by Shaw Science Partners, a public relations firm that works for drugmakers and helped launch more than 30 drugs, according to its web site (you can the back story here). The committee also wrote Mike Shaw and EthicAd to learn more about their involvement (here and here).