Thursday, May 28, 2009

This is Your Government on Drugs

Sitting through the litany of risk warnings that accompany TV pharmaceutical ads -- including the dangers of the 4-hour erection -- one wonders why companies bother running them. These ads are supposed to tout the virtues of their wonder products, but government mandates and lurking trial lawyers mean that they also must warn viewers, ad nauseum, about the risks they present, including blindness, stroke, hemorrhaging, heart attack, death, the heartbreak of psoriasis.

In some of the ads, more than half the 60-second spot seems devoted to reading the warning label. I now know more about how Brand X can destroy my liver than I do about what it does to help my ulcer. Whether that makes this a safer society, or me a more "educated consumer," is doubtful. I'll still rely on my physician to recommend a drug, weighing the risks versus the benefits. I treat these warnings like I treat the seatbelt demonstrations before a flight, or announcements in the terminal about the homeland security threat level. It's just background noise after a while.

I'm for honesty in advertising, up to point. This, however, seems like alarmism in advertising.

Drug companies are spending hundreds of millions of dollars highlighting the dangers their products present to the public. Yet that isn't enough for the Food and Drug Administration. Hot on the heals of its attempt to declare Cheerios a drug, based on the allegedly misleading health claims made for the cereal (wait till they get hold of Wheaties!), the agency now is taking real drug-makers to task for using deceptively upbeat background music and "distracting images" to downplay those disclosures.

Reports Reuters:

US warns of TV drug ads' distracting music, images

WASHINGTON, May 26 (Reuters) - Television ads for drugs and medical devices should avoid distracting images and music that can reduce viewers' comprehension of potential side effects, U.S. regulators advised in guidelines proposed on Tuesday. Advertisements also should use similar type styles and voice-overs when conveying benefits and risks, the Food and Drug Administration said.

The guidelines follow complaints that manufacturers use various techniques in their widely seen television ads and other promotions to downplay risks while emphasizing potential benefits. Leaving out or minimizing side-effect information is the most frequent violation the FDA cites in letters to companies complaining about misleading promotions.

The guidelines FDA is providing "are not mandatory," notes Reuters. Not yet. But they are troubling. The federal government rarely limits itself to moral suasion for long when mandates are available. And it's not hard to imagine a day when the agency will demand script approval and "creative control" over every drug ad on television.

More Reuters:

"The [agency's) advice covers techniques ranging from the use of contrasting colors to highlight information, the location and timing of risk details and other factors that can influence how well viewers understand a product. Prescription drug ads have drawn fire for portraying healthy-looking, active and smiling patients while explaining benefits and then rushing through or providing distractions when required risk information is conveyed.

At a congressional hearing last year, a Schering-Plough Corp ad for allergy drug Nasonex drew criticism for featuring a bee that flew around during a description of side effects but simply hovered while benefits were explained. In the new guidelines, the FDA said busy scenes, frequent scene changes and moving camera angles "can misleadingly minimize the risks of the product being promoted by detracting from the audience's comprehension. "The FDA also warned against speeding up an announcer's description of risks. "If risk information is considerably more difficult to hear and process than benefit information because it is presented at a much faster pace, the piece will not convey an accurate impression," the agency said.

Rather than call the meddling ridiculous, or sue on First Amendment grounds -- steps that risk bringing down the wrath of congressional committees or federal regulators on their heads -- the companies are doing what most American companies do in such circumstances. They're groveling. The industry remains committed to producing "responsible, balanced promotional materials," and they've adopted voluntary guidelines that say risks "should be presented in clear, understandable language without distraction," a spokesman for the Pharmaceutical Research and Manufacturers of America told Reuters.

Does the agency really expect drug makers to continue buying ad space to promote the dangers, rather than the benefits, of their products? Apparently. But the companies don't have the stomach to fight it, so the government's demands will become more insistent, and more extreme, over time.

Just imagine an America in which every advertiser has to follow similar "guidelines." Here's a car commercial, circa 2012:

"Driving this or any other automobile in an unsafe manner, and failure to obey all road signs and postings, may result in crushing injuries, dismemberment, defenestration or death. Following too closely can lead to rear-end collisions. Objects are closer than they appear in mirrors. Failure to properly maintain this vehicle -- to regularly refuel it and check the oil -- can result in poorer performance than these images convey. Do not smoke, light matches or play with fire during re-fueling. Riding on the hood of this vehicle at high speeds is not recommended. Don't drive this vehicle when distracted, inebriated, angry, suicidal, morose, or while listening to heavy-metal music. Keep four wheels on the pavement at all times. Having sexual relations in this vehicle without adequate precautions can lead to pregnancy, STDs, marriage or heartbreak. Do not stand behind this vehicle on a steep grade unless the parking brake is engaged. Do not speed into fog banks. Do not careen around corners. This vehicle is not waterproof and will sink if driven off a bridge. If you don't know how something works, consult your car care professional. If you don't know how to drive, seek driver's training. If you have problems with your warranty, or need more information about the dangers this vehicle presents under certain circumstances, please contact the office of the federal car czar."

Barack Obama's FDA shows early signs of being addicted to the most potent and dangerous drug of all: the drug called "Power." It doesn't come with a federally-approved warning label, unfortunately. The side effects have to be discerned by consulting history books.

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