Warning: New drug commercials may cause drowsiness


Big Pharma experienced acute dizziness and irritability last month when House Ways and Means Chairman Charles B. Rangel (D-N.Y.) proposed rescinding the tax deduction for direct-to-consumer prescription drug advertising. This is the ad segment that brought you “Viva Viagra,” the Ambien CR rooster and the Cialis couple-in-the-tubs, who I sincerely hope are soon struck by lightning. The segment accounts for about $5 billion in advertising per year. This is your IRS on drugs.

Predictably, the advertising/marketing community flew into a funk beyond the reach of Paxil and Cymbalta. Assn. of National Advertisers President and Chief Executive Bob Liodice, in high moral dudgeon, claimed in an Advertising Age editorial that the provision would violate the 1st Amendment (it wouldn’t), endanger the public’s health (hardly) and put Congress on a slippery slope of penalizing “controversial” products’ advertising, which could “imperil many, if not all, product categories.”

Indeed, the very foundations of the Republic rest on whether Pfizer can deduct the $121 million it spent in 2008 pushing Viagra on less-than-ardent oldsters.


I, for one, do not fear for the drug ad tax deduction. The pharmaceutical and health products industry disgorged more than $234 million upon Capitol Hill last year, according to the Center for Responsive Politics. I’m sure Big Pharma’s voice will be heard.

And yet there are darker clouds on the horizon for direct-to-consumer drug ads, in the form of new rules about the presentation of “risk information” proposed in May by the Food and Drug Administration. Currently in draft form, these rules would dramatically raise the legal bar for risk disclosure. Not only would advertisements have to fully explicate serious side effects, the nature of adverse reactions, the risk of dependence, dangerous drug interactions and so on, but all of that would also have to be communicated in the most direct, unambiguous and, if you will, artless form possible.

These rules would seem to forbid anything but the most droning, ominous recitation of possible risks for just about any medication, because just about any medication has potential side effects. What the FDA is describing is anti-advertising.

In the interests of the FDA’s “balanced manner” requirement, ads could not resort to any kind of small print -- including AM-radio-style rapid-fire delivery -- technical language (say, using “syncope” instead of “fainting”) or linguistic chicanery that reduces the impact of the risk information. For example, the familiar construction “like all medicines, Drug X has some side effects . . .” would get called on account of its tending to minimize the risk of side effects (compare the latest Celebrex ad).

Nor could an ad just blurt out a bunch of possible side effects about, say, an antidepressant while showing scenes of happy people with up-tempo reggae playing in the background. Images of “people enjoying the benefits of the product while major risks are communicated in a voice-over,” according to the draft guidelines, “may be too distracting for the audience to listen to or process the risks.”

And there’s more, much more, covering everything from the size and shape and background of type to the order in which serious side effects are listed (cognitive psychology suggests people’s attention drops off in the middle of long lists).

Not that I have any sympathy for Big Pharma. The industry has waged a long and inglorious campaign against tighter drug advertising regulations and can be counted on to weasel the rules as much as possible. But as a consumer of advertising, I dread the next generation of ads that warn me, in ever more vivid shades of hysteria, of the potential risks of dropsy, venereal forehead, explosive leg syndrome and chronic turkey neck resulting from my decongestant.

Consider, the current 75-second spot for Abilify, a powerful antipsychotic drug marketed as a potential add-on to antidepressants. At the 33-second mark, the warnings start: “thoughts of suicide,” “elderly dementia patients . . . have an increased risk of death or stroke,” “uncontrollable muscle movements [that] may become permanent” and so on. The astonishing thing is that Bristol-Myers Squibb spent more than $35 million in the first quarter alone to market this witch’s brew.

Seizures, death, trouble swallowing. Jeez, I get depressed just watching the ad. Maybe that’s the idea.

Another wonder drug -- as in, I wonder if this will kill me? -- is Wyeth’s Pristiq. Again, the potential adverse reactions are alarming: “Antidepressants can increase suicidal thoughts and behaviors in children, teens and young adults,” the ad says. “May cause or worsen high blood pressure, high cholesterol and glaucoma.”

Scary stuff. And yet, the FDA might say, not scary enough. Because the voice-over rambles on with a litany of potential side effects, some of which is quite hard to follow, the commercial seems to violate the FDA’s constraint that advertisements not overwhelm viewers’ “cognitive load.” On a more prosaic level, the imagery of this suffering woman suddenly redeemed by this medication, so that now she’s playing with her family at the park, seems to vastly over-promise relief.

Start looking and you’ll find all sorts of cunning ways drug ads de-emphasize risk information. My favorite is Lilly’s ad for the antidepressant Cymbalta, which was a big part of the product’s $180-million ad buy in 2008. The story line involves a depressed woman whose Weimaraner looks soulfully into her eyes, searching for his old master. She takes Cymbalta. Then the piano score moves to a major scale, and soon we see her happily walking her dog through a field. “Severe liver problems, some fatal, were reported. . . .”

Huh, what? Did somebody say liver?

Drug advertising is widely loathed for driving up prescription drug costs and priming the pump of American hypochondria: 77% of patients who asked their doctor for a drug they had seen advertised walked away with a prescription. And yet Congress has had little success reeling the industry in. Rangel will do no better. The new FDA guidelines suggest that if drug advertising can’t be banned outright, it might be regulated to death.