The Food and Drug Administration relied on a non-profit run by a pharmaceutical industry advertising consultant to help design its new campaign to educate consumers about direct-to-consumer drug advertising. The FDA’s recently launched website, “Be Smart About Prescription Drug Advertising: A Guide for Consumers,” was developed by EthicAd, a non-profit run by Michael Shaw out of the offices of Atlanta-based Shaw Science Partners. Shaw’s firm claims credit for having helped launch over 25 pharmaceuticals, including Viagra, Celebrex, Zoloft, Cymbalta, and Rezulin, which was later withdrawn from the market because of safety concerns.

The site, which claims DTC ads "can provide useful information to consumers," focuses its home page on examples of legally correct and incorrect ads -- information more useful to ad designers who want to avoid running afoul of FDA regulations than to consumers. It does invite consumers to report violations of the law to the FDA's division of Drug Marketing, Advertising and Communication.

EthicAd, which is not registered as a non-profit with the Internal Revenue Service, is nominally chaired by renowned heart surgeon Michael Debakey, who died last July just a few months shy of his 100th birthday. Shaw, executive director of the group, is identified on the EthicAd’s website only as a former medical advisor to the National Library of Medicine at the National Institutes of Health, a post he held for three years nearly three decades ago. A loophole in Georgia law allows non-profits to incorporate in the state without registering with the IRS, so financial records for EthicAd are not publicly available. Shaw Science Partners, on the other hand, racked up $1.6 million in revenue in 2006, according to manta.com.

In an interview with Integrity in Science Watch, Shaw admitted that his firm and other members of EthicAd’s board underwrite the group’s expenses, which enables it to donate its services to the FDA. “All members do work for industry; if not all, almost all,” Shaw said. EthicAd’s leadership includes general counsel Marc Scheineson, a former FDA official who is general counsel for EthicAd and a partner at Alston & Bird, a Washington-based lobbying firm with numerous drug and health care industry clients.

Steering committee members include Laura Benson, director of communications at OSI Pharmaceuticals; John H. Greist, director of Healthcare Technology Systems, which serves the drug industry; Michael A. Jenike, a professor of psychiatry at Harvard Medical School, Sheldon H. Preskorn, a professor of psychiatry at the University of Kansas School of Medicine, Michael Weber, a professor of medicine at New York Downstate Medical Center in Brooklyn, and Henry Black, a professor of internal medicine at New York University School of Medicine, each of whom has received either research funding or consulting fees from multiple pharmaceutical firms.

This story first appeared in Integrity in Science Watch, a publication of the Center for Science in the Public Interest.