Healthy Skepticism Library item: 14497
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
FDA website on DTC under investigation
PMlive 2008 Oct 16
http://www.pmlive.com/pharm_market/news.cfm?showArticle=1&ArticleID=7118
Full text:
The US House Committee on Energy and Commerce has opened an investigation into a new website launched by the US Food and Drug Administration (FDA) to provide information to the public about how to interpret direct-to-consumer (DTC) prescription drug advertising.
Democrats John Dingell, who chairs the committee, and Bart Stupak, who chairs the Oversight and Investigations Subcommittee, opened the probe in response to concerns about the involvement of a non-profit group called EthicAd in the site’s creation.
The FDA was upfront about EthicAd’s contributions when it unveiled the website, referring to the group as a non-profit partner in the project. EthicAd describes itself as an independent organisation that does not accept funding from the pharmaceutical industry. The group’s stated mission is to maximise the public-health benefits of DTC advertising.
However, Dingell and Stupak point to a recent report from the Center for Science in the Public Interest (CSPI), a consumer advocacy group focused on health and nutrition issues, suggesting that Ethicad has strong ties to the pharma industry, making its participation in the site’s development potentially inappropriate.
According to CSPI, EthicAd “is nominally chaired by renowned heart surgeon Michael Debakey, who died last July just a few months shy of his 100th birthday”, but it is in fact headed up by executive director Michael Shaw, president of Shaw Science, an Atlanta-based pharma branding agency that has worked on brands including Viagra, Celebrex, Zoloft, Cymbalta and Rezulin. Other EthicAd leaders also have strong industry ties, CSPI maintains.
Because Georgia law does not require non-profits incorporated in the state to register with the Internal Revenue Service, no financial records for EthicAd are publically available, CSPI notes.
Dingell and Stupak have instructed the FDA to provide the committee with all records related to the website as well as all records concerning the agency’s communications with and/or payments to EthicAd and Shaw Science. They are also seeking the agency’s records on its interactions with the trade group Pharmaceutical Research and Manufacturers of America concerning the website.
The website at issue can be viewed at www.fda.gov/cder/ethicad/.
Separately, the two lawmakers, who have had the pharma industry in their sights for some time, have opened an inquiry into the safety and effectiveness of Bayer Aspirin with Heart Advantage, a combination of aspirin with phytosterols, which Bayer’s product materials describe as “a natural plant-based supplement… clinically proven to lower bad (LDL) cholesterol, which may help reduce the risk of heart disease.”
In a letter to Gary S Balkema, president of Bayer HealthCare, Dingell and Stupak demand to know why “the company has ignored FDA recommendations to refrain from marketing” products that combine an over-the-counter drug with a dietary supplement.
The letter to Bayer also asks for a range of other information, including “all records relating to studies, both positive and negative, that demonstrate the effect of Bayer Aspirin with Heart Advantage on cholesterol and heart disease”, all records related to the company’s communications with the FDA about the product, and all records “relating to internal deliberations regarding development and marketing of the combination product from the date of the discontinuation of Baycol to the date of the launch of Bayer Aspirin with Heart Advantage”,
Bayer voluntarily withdrew Baycol, a cholesterol-lowering statin, from the market in 2001 after it was linked to a sometimes-fatal muscle adverse reaction called rhabdomyolysis.
