Selfless, benevolent FDA enforces the LETTER of the law... You'll no doubt remember how last month I ranted and raved about all the slick drug ads on TV nowadays -- and how they're designed to do nothing more than convince you that you're sick, then provide you with an easy-to-pop solution... JUST ASK YOUR DOCTOR! Well, as if on cue, a February article in that often-quoted paragon of American commercial meritocracy, Consumer Reports, covers just this subject -- and their findings are at once vindicating (because after all, I told you so) and distressing. First off, it turns out that a frighteningly large percentage of people really DO ask for specific drugs by name when they go to the doctor... What I didn't count on was how willingly those doctors prescribed the specific medication their patients requested -- up to 80% of the time, according to recent surveys. Eighty percent? Boy, I'll say those direct-to-consumer ads work, and how! But what really gave me cause for alarm was the fact that according to the article, 43% of people -- excuse me, consumers -- labor under the ENTIRELY FALSE notion that the FDA stringently regulates drug ads, and that only "completely safe" patent medicines can be advertised. This is a scary testament to the fact that many (if not most) Americans believe their government paternalistically protects them from harmful substances... Nothing could be farther from the truth. The truth is that the typical FDA review of a drug advertisement is conducted AFTER the ad has already been released into widespread circulation! Do they know if the drugs being advertised are safe before we see the ads -- and maybe even demand the drug from our doctors? No. In fairness to the FDA, though, there is a system of "checks and balances" in place designed to discourage drug companies from engaging in any intentional deception. And it's a real comfort, to If a drug maker is found to have made fraudulent or misleading claims in its ads, they face a stiff penalty... A letter. That's right -- they get a stern talking to! According to the article, those fierce disciplinarians at the FDA averaged 100 or more of these letters per year throughout the 1990s for such violations as:
Minimizing (or omitting) drug risks
Exaggerated claims of effectiveness
False claims of superiority over competing drugs
Suggesting unapproved uses for drugs
Promoting drugs still in the experimental phase
Inconsistency of labeling information
Misleading physicians
Interestingly enough, the number of these "penalty" letters has dwindled in recent years. As of November 2002, only 24 had been dealt out for the year -- maybe they were planning to hand out 76 more as stocking stuffers?
The obvious question is: What happens to drug makers who've received a letter if they don't change their ads? (Probably nothing) But the not-so-obvious question is this: Is the real purpose of these letters only to shield the FDA in the event of a scandal? Here's the bottom line: If the FDA were concerned about protecting you from harmful drugs, they'd thoroughly review the ads before they ever reach the airwaves and pages. Or they'd hold drug companies accountable for their deception in meaningful ways -- like fines in the million-dollar range... But if they really cared, they'd ban all these ads in the first place. Sometimes being cautious can't hurt,
William Campbell Douglass II, MD | 
