Once upon a time (the early 90s) most prescription drug ads resided safely within the pages of medical journals read largely by physicians. Their color contrasted sharply with the black and white text that surrounded them. Like other kinds of advertising, they were there to grab physicians' short attention spans. Accompanying the ad, however, was vital prescription information that described potentially harmful side effects and contraindications. Until a few years ago, the FDA required pharmaceutical manufacturers to include these extensive consumer warnings in their sales pitches to physicians.
Fast forward to 2001. Colorful print ads still populate the pages of journals. And they're still mostly read by doctors. But turn on the television at any given prime-time hour and you can see the color ads for prescription drugs that vied for space in the medical journals transported to the small screen. Along with their new home, the ads have a new audience of millions of consumers, many of whom have not heard of the drugs -- or the disorders -- until recently.
Some ads, such as a recent one for a medication to treat premenstrual dysphoric disorder (PMDD), are cryptic. A woman wrestles with a shopping cart trying to dislodge it from its stack to no avail. We watch her frustration mount while a voice in the background recites the symptoms of prementstrual syndrome. "Think it' s PMS?" the voice asks. "Think again. It could be PMDD." Mention of this new condition is followed by mention of a new drug (actually the old drug fluoxetine). The focus shifts to a different woman. Her confident demeanor and immediate success in releasing a cart from the stack leave little doubt: she' s taking the old drug for the new condition.
You may remember seeing this advertisement at the beginning of the year, before it was pulled for modification. The Food and Drug Administration (FDA) objected that the televised spot failed to distinguish PMDD from the more familiar PMS. The FDA's chief complaint was that the overall message broadened the indication for the drug and trivialized the seriousness of the condition it treats.
The FDA's issuing of warnings like these has been on the rise ever since relaxed rules for pharmaceutical advertising in 1997 made it easier for drug companies to market their products on television. While most companies respond to FDA warnings by altering the problematic content of their ads, they are under no obligation to comply with the agency's recommendations. This may surprise many, who view the FDA as a regulatory agency with teeth. In fact, the agency's watchdog role in advertising is limited to embarrassing drug manufacturers rather than fining or punishing them.
It wasn't long before a new ad for treating PMDD was on the air: one that captured the significant impairments that accompany PMDD. Several women are portrayed as they go through bouts of depression, anger, or moodiness that interfere with their daily routines and relationships. The tone of the ad is darker, the disorder more serious, than those of its predecessor.
Most ads, however, are cheerful and upbeat. Rather than focusing on the drug itself, the ad creates the mood its marketers want consumers to associate with the drug. In this way, the ads are quite similar to more conventional advertising. They differ in that the bright and sunny images are accompanied by a voiceover that quickly lists some of the side effects of the drug; an 800 number or Web site where consumers can obtain more information is flashed on the screen. If the sound on your set were muted, you would be hard pressed to tell what the images were trying to sell.
The juxtaposition of upbeat images alongside dour warnings creates a strange mixture that is unique to this genre of advertising -- one that reflects the delicate balancing act that advertisements for prescription drugs have to perform. Through their ads, pharmaceutical companies deliver information that is meant, on the one hand, to make the public more knowledgeable about a condition and its corresponding treatment and, on the other hand, to plug a given product. The line between empowering people to become better-educated consumers and manipulating them to buy drugs of a particular brand is easily crossed. That is why controversy surrounds the upsurge in marketing prescription pharmaceuticals directly to general audiences -- especially when there are less-expensive alternatives that are thought to be as effective as, or better than, the one advertised.
Direct-to-consumer advertising, with its pros and cons, is probably here to stay. With this in mind, some guidelines have been written that apply to physicians. The AMA's Code of Medical Ethics, for instance, admonishes that "Although physicians should not be biased against drugs that are advertised, physicians should resist commercially induced pressure to prescribe drugs that may not be indicated. Physicians should deny requests for inappropriate prescriptions and educate patients as to why certain advertised drugs may not be suitable treatment options providing, when available, information on the cost effectiveness of different options."
Although the ads reach consumers directly, interested consumers cannot obtain the advertised drug without a physician's prescription. Thus, the burden for delivering pharmaceuticals to patients responsibly still rests with the medical profession. Physicians are the only professionals who can legally prescribe all drugs and with this authority comes a concomitant duty to better educate their patients. Whether or not drug companies advertise their products properly, physicians are ultimately responsible for the quality of patient care.