Flip on the TV, and within a short time you'll likely see an upbeat ad for a supposed wonder drug. More often than not, it ends with a list of daunting risks.
In the four years since the Food and Drug Administration (FDA) allowed pharmaceutical companies to promote directly to consumers on television, such paradoxical commercials have flooded the airwaves and transformed the American medical landscape.
Supporters, like pharmaceutical companies, contend that when Joan Lunden takes a deep breath and marvels at the antihistamine Claritin in a 30-second spot, she's helping to educate and empower a public hungry for medical information to help them help themselves. That, supporters say, helps improve the nation's overall health.
But to critics, such ads change the balance in the doctor-patient relationship and create an unrealistic expectation there's a cure-all in a pill. They also charge that direct-to-consumer advertising, known as DTC, fuels skyrocketing drug prices by prompting consumers to buy vastly more expensive drugs than doctors say they need.
Amid the controversy, the FDA is now reviewing its guidelines governing DTC to determine the true nature of the impact.
Historically, doctors have always held the key to pharmaceutical drugs through their prescription pads. Indeed, from the 1550s through the late 1980s, the belief was that if used without proper knowledge and training, prescription drugs could be dangerous. So decisions about their use were thought best left to doctors.
But to pharmaceutical companies, doctors were middlemen that kept them from appealing directly to consumers. In the 1980s, they pushed the FDA to lift its moratorium on DTC, citing patients' desire for more information to help them make informed decisions. The FDA complied, but it set out guidelines that made only print advertising possible, by requiring drug companies to supply comprehensive information about potential side effects.
What commercials must include
In 1997, after increasing pressure from the pharmaceutical industry and TV networks, the FDA wrote new guidelines. They said commercials could be broadcast if they included "information about any major risks," as well as where to obtain "more detailed information" such as an 800 number or a website.
That opened the floodgates. In 1991, drug companies had spent $51 million on advertising. By 2000, it topped $2.3 billion. Sales of the most heavily promoted drugs - which tend to be more expensive - increased 30 to 50 percent. Experts say that has helped fuel spiraling healthcare costs. Prescription-drug prices are increasing at 18 percent, twice the overall rate of healthcare inflation.
"It's not so much the price of a particular drug going up. It's new drugs coming on the market that are substitutes for older ones," says Mary Nell Lehnhard, senior vice president of Blue Cross Blue Shield. "In a good number of cases, the older drugs were just as effective, but less expensive."
Her favorite example is the arthritis drug Celebrex. It costs about $900 a year. The older alternative is ibuprofen, which costs about $24 a year. "Any clinician will tell you that only about 6 percent of the population using Celebrex really needs it. Those are the people who are at risk of gastrointestinal [problems]," says Ms. Lehnhard. "For the rest, ibuprofen is just as effective."
Which leads to doctors' concerns. The American Medical Association contends the current advertising offers only "snippets of information," instead of more substantive data that a patient might need to make a truly informed decision.
"It can create an adversarial relationship between the doctor and the patient, because the patient wants this greatest, newest, and best thing they saw on TV, and the doctor may not think it's necessary," says Dr. Thomas Reardon, a past president of the AMA.
Other critics add that as managed care has squeezed doctors' time with patients, it's made it more difficult to have in-depth conversations on drug choices. As a result, many may feel pressured to prescribe the new drug.
"What you're basically asking the doctor to do is unsell the drug that sounds so good to the patient. That's difficult," says Larry Sasich, a pharmacist at Public Citizen's Health Research Group in Washington.
In Old Saybrook, Conn., periodontist James McAraw says he's had patients ask for drugs before the medical community has had time to properly assess them.
"I won't prescribe anything until I see clinical studies are well done by reputable members of my profession," says Dr. McAraw.
That's another way DTC has changed the medical landscape. In the past, there was a "gentle curve" when a new drug entered the market because doctors tend to be cautious. The time acted as a buffer when unexpected reactions could be reported. Now, when new drugs enter the market accompanied by multimillion-dollar ad campaigns, the goal of pharmaceutical companies is to get it out to as many people as fast as possible.
In October 1999, GlaxoSmithKline advertised its new flu drug Relenza. Soon after, seven patients who were using it died. Because the drug was so heavily advertised, the FDA issued a "public health advisory," warning the drug should not be used by people with underlying respiratory problems. It also determined the company's ads were misleading, and they were pulled. The drug remains on the market but with a stronger warning.
Balance between doctors and patients
Advocates of DTC say such cases are rare. They note that the prescribing power still lies with doctors. From their perspective, the advertising empowers patients at a time they are becoming more interested in their health and more distrustful of healthcare providers.
"People are now able to have more informed conversations with their physicians," says Meredith Art, spokesperson for the PHRMA, the pharmaceutical industry's trade association. "It also helps solve the problems of underdiagnosis and undertreatment."
A study by Pfizer Inc., maker of Viagra, found that of the 7 million people who approached a doctor about the drug, more than 1 million discovered an unrelated illness.
"There's a burgeoning self-care movement in the US," says Ed Slaughter of Prevention Magazine, "and DTC empowers people." The FDA is taking comments on its guidelines.
(c) Copyright 2001. The Christian Science Monitor