FDA Using Pharma DTC Pro
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having helped launch over 25 pharmaceuticals, including Viagra, Celebrex, Zoloft, Cymbalta and Rezulin, which was later withdrawn from the market because of safety concerns.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's home page, which claims DTC advertising "can provide useful information to consumers," contains examples of legally correct and incorrect ads -- information more useful to ad designers who wish to avoid running afoul of FDA regulations than to consumers. The site does invite consumers to report violations of the ad rules 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 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; and steering committee members 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 (Black can be found in the Integrity in Science database), 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.
Tip of the hat to the National Women's Health Network for pointing out the FDA-EthicAd website. Got a tip? Send it to firstname.lastname@example.org
Med Center Conflict Policies Compared
The Institute on Medicine as a Profession (IMAP) says some of the nation’s leading medical schools have weak or nonexistent conflict of interest policies, including Johns Hopkins University School of Medicine, Harvard University, Washington University in St. Louis, Brown University and Tufts. The ratings were included in a new database listing the conflict of interest policies for 90 of the nation’s 125 academic medical centers (AMC).
The site reveals policies at AMCs for regulating professors’ relationships with industry involving free gifts, meals, drug representative access, samples, purchasing committees, continuing medical education, consulting and honoraria, scholarships and travel, ghostwriting, speakers’ bureaus, enforcement, and implementation. While IMAP does not rank AMCs, the site gives examples of “best practices” and model policies that have been adopted within the University of California system, the University of Pennsylvania, University of Pittsburgh, University of Massachusetts, Yale University, and the University of Louisville.
Grassley Slaps U Texas on Disclosure
Senate Finance Committee ranking member Charles Grassley (R-IA) revealed last week that two researchers with the University of Texas Medical Branch failed to disclose income from pharmaceutical companies while receiving public funding for conducting research on antidepressants in children. “Starting today the NIH could send a signal that business as usual is over,” Grassley said. “The simple threat of losing prestigious and sizable NIH grants would force accurate financial disclosure.” Grassley has raised similar criticism of other universities, including Stanford, Harvard, and University of Cincinnati. According to Grassley, UT’s Karen Wagner was engaged in a National Institute of Health study on the use of Paxil to treat teenage depression and another study on teen anxiety while receiving more than $220,000 between 2000 and 2005 from antidepressant makers. In addition, UT’s Joshua Rush, who also ran the state’s Texas Medication Algorithm Project for determining when to use antidepressants, was paid $17,802 in 2001 by Eli Lilly, which makes antidepressants.
Industry to Fund NIEHS Booklet on EMF Safety
The Electric Power Research Institute (EPRI) is planning to fund the National Institutes of Health to sponsor a public information booklet on electromagnetic fields, according to Microwave News. EPRI, the research arm of the utility industry, would funnel contributions from its member companies to an NIEHS fund that would then be used for an update of "EMFs: Questions and Answers.” The current version was sponsored by the EMF-RAPID Program, a six-year program launched in 1992 by the Department of Energy and the NIEHS with equal amounts of funding from the government and industry. According to EPRI’s flyer asking utilities to contribute $30,000 apiece to the update, the booklet will serve as “a communication piece…with member companies and public stakeholders.” Spokesmen for EPRI and for the NIEHS say that the utility companies will have no control over the booklet’s content.
Odds and Ends
The Food and Drug Administration's lax regulation of mercury in tuna fish was the result of pressure from industry, according to Mother Jones magazine. . . . The Department of Interior (DOI) Inspector General’s office released a report last week citing conflicts of interest at the Colorado office of the Minerals Management Service. Employees of the agency that collects royalties from offshore drilling accepted gifts including ski trips, sports tickets and golf outings; steered contracts to favored firms; and engaged in sex and took cocaine with industry officials, according to the two-year investigation . . . . The American Petroleum Institute, National Association of Manufacturers (NAM), National Mining Association, and the American Iron and Steel Institute joined Alaska’s lawsuit against the U.S. Fish and Wildlife Service’s listing the polar bear as a threatened species. Environmental groups, which say an endangered listing —which would give the bear a higher level of protection under the Endangered Species Act— is more scientifically defensible than its current threatened status, are preparing to sue FWS. . . .
Cheers and Jeers