FDA in Bed with Bogus Non-Profit

Merrill Goozner, editor of GoozNews, broke this story first in Integrity in Science Watch, published by the Center for Science in the Public Interest, and then reported it on GoozNews.

The post deserves maximum exposure because it illustrates just how underhanded the FDA has become in recent years—while posing as a regulatory agency.

It seems that the Food and Drug Administration turned to “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helped launch over 25 pharmaceuticals, including Viagra, Celebrex, Zoloft, Cymbalta, and Rezulin, which was later withdrawn from the market because of safety concerns.”

Goozner points out that 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.”

To read the rest of the post, go to http://www.gooznews.com/ and scroll down to September 15.

I would add only that real spending on direct-to-consumer advertising increased by 330% from 1996 to 2005 climbing to nearly $30 billion. And, as the table below (originally published in the New England Journal of Medicine) shows, drug industry spending on promotion now equals over 18% of sales.

In other words, 18 cents out of every dollar that you spend on prescription drugs is used to pitch you or your doctor via ads, free samples and “detailing”—visits by the drug rep to your doctor’s office.

Meanwhile, the NEJM reports, “the number of regulatory actions taken by the FDA against companies marketing prescription drugs to consumers has fallen dramatically in recent years. This decline may reflect either better industry compliance with advertising regulations or a worsening of FDA oversight.

The evidence suggests that the FDA has purposefully lowered the level of regulations. “First,” the NEJM study reports, “in 2002 the Secretary of Health and Human Services began requiring that all draft FDA regulatory letters, including letters related to advertising violations, be reviewed and approved by the FDA's Office of Chief Counsel before they are issued. A GAO report found that this legal review has led to a reduction in the number of letters issued, as well as to delays such that FDA warning letters are frequently sent out long after the false or misleading advertising campaign has run its course. Notably, the number of regulatory letters sent by the FDA in 2002 was less than half that in 2001 (28 vs. 68).

“A second indication of weakening FDA oversight of direct-to-consumer advertising in recent years is that the number of staff members who are dedicated to reviewing advertisements has remained relatively stable, whereas the use of such advertising has grown substantially. In 2002, three FDA staff members were dedicated to reviewing direct-to-consumer advertisements. In 2004, four staffers were reviewing such advertisements, even though spending on this form of advertising (and probably the volume of ads to review) had increased by 45%, from $2.9 billion to $4.2 billion . 

“Finally…the proportion of broadcast advertisements that underwent FDA review before airing declined from 64% in 1999 to only 32% in 2004.”

Yet apparently, the FDA did have sufficient resources to launch an ad campaign touting the virtues of DTC advertising.

Comments

[Maggie Mahar]

Panacea--

I couldn't agree more.

First we need a new FDA commissioner who has no ties to industry.

[Panacea]

It is high time something was done about the FDA, to take control of it away from politicians and special interests and return it to its function of protecting the public.

Perhaps it should be run by a board of physicians, nurses, and private citizens (much like licensing boards)--potential members are disqualified if they own substantial amounts of pharmacy stock, if they or family members work for the pharmaceutical industry or lobby for it, or if other conflicts of interest appear.

Big Pharm can't have a seat. We need to get the fox out of the henhouse.