Opinion: The FDA's Battle With Bogus Drug Claims

(Nov. 23) - We've all sat in front of the TV listening to an earnest-looking man in a white coat confiding in us that the new drug he holds will save – or at least markedly improve – our lives. In the back of our minds, we recalled something about government agencies protecting us from false advertising.

When it comes to medication, that's one of the jobs of the Food and Drug Administration. It also seems like a nearly impossible task: In addition to mainstream pharmaceutical companies, there are now an estimated 16,000 cyber-pharmacies offering thousands of real and bogus wonder cures, and all of them need monitoring.

Still, as short-staffed as the FDA says it is, the agency does a pretty good job of busting some of the bad guys who profit from our gullibility.

Last week alone, for instance, it sent warning letters to roughly two dozen companies – some as far away as China, Russia and Turkey – to tell them to knock off their advertising and sales of bogus medication.

In almost all of the cases, the companies were offering versions of "Herbal Xanax," "Herbal Viagra," generic Valium and a dozen other alleged medications not approved by the FDA and thus illegal to advertise for sale.

What's more, the agency says, the labeling is misleading, erroneously suggesting that the products contain FDA-approved Xanax, Ambien or Viagra.

Several of the companies were also selling Rimonabant, the chemical compound used in the anti-obesity drug Acomplia. The FDA has said that Rimonabant does not meet its requirements for safety and effectiveness "because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness and suicidal thoughts among patients."

It's not only the fly-by-night online pharmacies that the government goes after. FDA enforcement files burgeon with cases of false or misleading advertising against the big boys of the multi-billion-dollar drug world.

Companies such as Pfizer, Wyeth, Johnson & Johnson, Eli Lilly and Purdue Pharma have all been cited for crossing the line in their marketing efforts, often by making unsubstantiated claims of effectiveness and grossly overstating safety.

Sometimes, food and consumer activists don't wait for the FDA to act, forcing a labeling change themselves. In late 2006, the Center for Science in the Public Interest, a nonprofit food safety advocacy group, helped bring a class-action suit against the makers of Airborne. Many travelers (like me) had read about and tried the tube of multivitamins and herbal supplements, believing its claims of preventing colds in crowded, germ-infested environments.

I mean, it was concocted by second-grade teacher Victoria Knight McDowell to protect her from the germ-spewing tykes who surrounded her each day. How could it not work?

Last year, under the terms of a settlement in the false-advertising suit, Airborne agreed to pay $23.3 million in refunds.

Throughout this summer and fall, bogus medical claims seemed to soar in proportion to swine-flu reports. The FDA and the Federal Trade Commission joined up in the chase. All told, the two agencies went after 143 illegally marketed, unapproved or unauthorized pills, powders, tinctures, air filtration devices and cleaning agents that claimed to diagnose, prevent, cure or kill the H1N1 virus.

In investigating those cases, the FDA purchased and analyzed several products represented as Tamiflu, the popular and sometimes hard-to-get prescription flu medicine. According to the agency, one of the orders, which arrived in a plain envelope from India, contained unlabeled white tablets taped between sheets of paper. The FDA's analysis determined that the tablets contained precisely none of Tamiflu's active ingredients.

Policing false and misleading advertising goes well beyond the "D" in FDA. The competitive and lucrative world of breakfast foods, for instance, are another fertile ground for deception.

Earlier this year, the FDA warned Cheerios, among others, to change the labels on its cereal boxes, which said eating its cereal can lower bad cholesterol and reduce your risk of having a heart attack.

It's an appealing notion: protecting your ticker by the spoonful.

It's also not true, says the FDA.