The Drug Company Knows Best

You may have noticed the trend. It's hard to ignore, really. Those TV ads that show happy folks skipping through sunny meadows as an invisible lounge singer croons "Blue skies smiling at me," or not-so-happy folks burping up their dinner while an announcer talks about acid reflux, or any of the other countless advertisements for pills that will help you quit smoking or lower your cholesterol or clear up your acne -- all followed by a list of side effects and a polite request to "Ask your doctor about ... [so and so]." Welcome to the world of prescription drug advertising.It's a relatively new phenomenon, brought on by the rise of managed health care -- which limits the products available to patients -- and the growing popularity of less expensive generic drugs. To compete, pharmaceutical companies are marketing their products directly to consumers ... even though the "consumer" does not make the ultimate buying decision.Doctors are concerned that this practice muddies the waters of health education and does a disservice to their patients."My feeling is that advertising, especially in the mass media, is always extremely biased," says Dr. Gregory J. Schilero, associate director of the medical intensive care unit and director of respiratory therapy at the Bronx VA Medical Center. "The layperson who is going to hear about a prescription medicine is going to get a very skewed view of the drug and its efficacy, and maybe not the full picture of what the detrimental downsides of the drug could be, and lastly, not about alternative medications that might A) be cheaper, B) be equally as good, C) have less of a side effect ... I think a doctor's more capable of providing their patient with that information."Although Food & Drug Administration (FDA) regulations require manufacturers to include in their print ads what is ironically called a "brief summary" -- a statement of the drug's side effects, contraindications and effectiveness which most often takes the form of a rambling package insert reprinted in tiny type on the back of the ad -- this information is hardly more than gibberish to the average consumer. And last August, the FDA revised its guidelines for broadcast advertising of prescription drugs to consumers; whereas in the past television ads could merely mention the name of the drug, but not its purpose, manufacturers can now say whatever they want about the drug as long as they provide a number to call for more information or rattle off a verbal version of the brief summary. Yet physicians remain skeptical. "I don't think the average person is going to grasp all of that," says Dr. Schilero.It's not that the public is stupid. But how many of us not in a medical profession recognize "certain cutaneous signs and symptoms" such as "erythema" and "pruritus" when we see them, much less know what they are?As any good marketing student knows, 80 percent of advertising is emotional. We're human; we can't help ourselves. When we see a sexy woman flirting with a guy in a sports car, we want to be the guy in the sports car. When we see an adorable little baby cuddling up in an "April fresh" blanket, we want to buy that fabric softener. When we see a funny little animated nose running around with sunglasses on, we think we need the name-brand drug he's hawking. And we tell our doctor so."Sometimes people ask for a drug without understanding what it does and before they've even been diagnosed," Dr. William E. Jacott told the American Medical News last year. Some doctors, he said, will be swayed by such requests.Dr. Schilero says a few of his patients have requested a specific drug they have seen advertised, but he is not more inclined to prescribe a medicine simply because a patient asked for it. "I think you always have to be objective ... When I prescribe, I'm trying to think of what's the best medicine for the patient."I think the doctor should stay as the buffer between the prescription drug market and the patient," Dr. Schilero continues. "Eliminating the doctor as the middleman has the potential to sway physician practices [through patient demand]. I'm not so sure that's a very objective way of doing things."Yet one pharmaceutical representative, who asked not to be identified, disagrees. "It's scary, but physicians aren't God. They make mistakes, they aren't as well-informed as we would like to think," he says. "So challenge them, go ahead, get in there. Even though the patient is getting obviously biased information [from ads] ... it can only help if the patient can bring something to the table. Not only that, but they'll feel more comfortable with the product. If a physician takes time to explain to them why they're taking this product versus another one, I bet compliance is going to go up."In a recent policy statement, the American Medical Association (AMA) "reaffirms its opposition to direct advertising of prescription drugs to the public; supports development of a mechanism to monitor advertising of prescription drugs to the public at the state and national levels; and supports advising federal agencies and pharmaceutical firms involved of the dangers of such advertising."Which is where the FDA comes in ... or does it? Don't pharmaceutical manufacturers have to run their ads by the agency before they are presented to the public?"No, absolutely not," says Nancy Ostrove, Ph.D., of the Direct-to-Consumer Advertising department of the FDA's Division of Drug Marketing, Advertising & Communications. "They have to go to us at the time of use or dissemination. So it's a post hoc process. They can voluntarily submit [ads] for review and comment, if they wish to." Which, adds Ostrove, many manufacturers do.Ostrove says that until the early 1980s, direct-to-consumer advertising of prescription drugs wasn't even considered. "When the regulations were written there just wasn't any [consumer advertising of prescription drugs]. ... Back in the '60s it just wasn't conceptualized as being something the pharmaceutical companies wanted to do."In 1983, when the first direct-to-consumer prescription drug ads appeared, the FDA asked for a voluntary moratorium on the practice until they could determine how to regulate it. In 1985 that moratorium was lifted, but it wasn't until the early 1990s -- and the change in the health-care climate -- that things started to pick up. As American Medical News reported last February, pharmaceutical companies' spending on advertising to consumers rose from $55 million in 1991 to almost $600 million in 1996 ... and it's still growing. In fact, in 1996 "direct-to-consumer prescription drug advertising outpaced ads aimed at health-care professionals" for the first time, the journal stated.In the meantime, the FDA is content with its new guidelines for broadcast advertising of prescription drugs and is currently reviewing its guidelines for print ads. Yet, according to Ostrove, there is little chance of the agency forbidding the practice outright. "It would probably take Congressional action," she explains, "because there's nothing in the regulations that give us the authority to prohibit it. And even if the Congress acted, if they tried to ban it, I have a suspicion that that would be questioned in the court, because you're talking about interfering with commercial speech, which has certain protections under the First Amendment."Of course, both sides of the issue see a more immediate force at work. "Obviously, the pharmaceutical companies are trying to make money. That's the bottom line," Dr. Schilero summarizes.The pharmaceutical rep agrees. "It's economics ... This is a huge industry."

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