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Consumer Drug Ads Facing Their Moment of Truth

Less show, more show-and-tell seen in wake of drug safety hearings

THURSDAY, March 10, 2005 (HealthDay News) -- The landscape of prescription drug advertising to consumers will definitely change in the wake of recent government hearings on the popular painkillers Celebrex, Vioxx and Bextra.

Exactly what the new panorama will look like is still unclear, but both industry and government officials predict consumers will be more educated and less entertained in the future.

Dr. Lester Crawford, acting commissioner of the U.S. Food and Drug Administration (FDA), which regulates prescription drug ads, has pledged more aggressive monitoring of drug ad claims so the benefits of powerful drugs are balanced by the risks. His words were echoed strongly last week by an FDA official who reviews drug ads for accuracy.

"Consider this a heads-up," the official, Kathryn Aikin, told 400 drug marketing executives in Boston on March 3, according to the Boston Globe. "We are very concerned about the direction consumer advertising seems to be taking."

But an FDA advisory panel's suggested ban on direct-to-consumer (DTC) advertising for the well-known painkillers known as cox-2 inhibitors is not about to happen.

Even if the FDA accepts the rest of the panel's recommendations -- that Celebrex, Bextra and Vioxx stay on the market but with warning labels and better consumer information on their cardiovascular risks -- the agency does not have the power to implement an outright ban on advertising.

Because of the First Amendment, the FDA "does not have the authority to ban direct-to-consumer prescription drug advertising," an FDA spokesperson said.

The issue of consumer advertising is a fairly critical one in light of the fact that DTC, on the rise for the past a couple of decades, may have reached a peak with the cox-2s. According to Nielsen Monitor-Plus, Pfizer spent $118 million last year on Celebrex ads, while Merck spent $71.8 million advertising Vioxx until last fall. That was when it pulled the drug off the market in wake of its own studies that showed increased heart risks.

And that kind of heavy advertising is certainly reaching its audience, it would appear.

In 2005, a recent Kaiser Family Foundation survey found, 90 percent of adults had seen or heard ads for prescription drugs, up from 76 percent in 2000. About one-quarter of the people who had seen these ads talked to their doctor about getting a prescription as a result of the ad. Of those who talked to a doctor, three-quarters (18 percent of all adults) actually got the prescription.

But while it's hard to forget Dorothy Hamill peddling Vioxx or smiling seniors practicing Tai-Chi courtesy of Celebrex, the concerns voiced by members of the FDA advisory panel are now being echoed by the public.

The Kaiser survey also found that only 18 percent of consumers now believe pharmaceutical ads can be trusted "most of the time." That's a far cry from1997, when one-third of those surveyed said ads could be trusted most of the time.

The black-box warnings recommended by most members of the FDA panel could also do their own part to curb direct-to-consumer advertising simply by making the proposition a less attractive one.

And the FDA does have some muscle. Under the Federal Food, Drug and Cosmetic Act, the agency has been regulating prescription drug advertising since 1962. (Over-the-counter drug advertising and most other advertising is regulated by the Federal Trade Commission.)

Pharmaceutical companies can advertise approved drugs if the ads are "truthful and not misleading," according to the FDA spokesperson. That means that warnings of risks must be prominently placed, which is not usually an enticement for consumers to buy.

The agency also has the authority "to take action against misleading or false advertising." It did that just last month when it issued a warning letter to Amgen Inc. that a TV ad for Enbrel overstated the effectiveness of the arthritis/psoriasis drug and minimized its risks. Amgen discontinued the ad as a result, and reportedly has no plans to reissue it.

The agency can also request that a company stop advertising altogether, an action it has taken twice. In the early 1980s, when DTC first started, the FDA asked manufacturers of two products to stop advertising until the agency had time to "evaluate its impact on public health," the FDA spokesperson said. The request was withdrawn a couple of years later.

And last December, the FDA requested that Pfizer suspend direct-to-consumer advertising for Celebrex while the adverse events linked to the drug were being evaluated. The company complied with the request and has suspended Celebrex promotions.

The pharmaceutical companies may have done their own harm by promoting drugs so heavily. "The contrast between that and the news that you could get a heart attack is impossible to overcome," said Paul Levinson, chairman of the department of communications and media studies at Fordham University in New York City.

But drug companies may already be changing their tactics as the result of the negative publicity that came out of the Vioxx withdrawal and the FDA safety hearings.

Cindy Callaghan, director of brand communications at AstraZeneca, described the company's new "unbranded educational ad," which "seeks to educate consumers about potentially serious NSAID treatment-related complications. We hope this piece prompts more informed patient/doctor discussions about the appropriate role stomach acid inhibition may play in reducing the chances of stomach ulcers developing among at-risk chronic NSAID users." AstraZeneca makes Nexium, which is used to treat the gastrointestinal symptoms sometimes associated with taking NSAIDs, nonsteroidal anti-inflammatory drugs. The older NSAIDs can cause gastrointestinal problems, while the new ones, such as Vioxx, were designed to prevent those problems.

Conceding that some of the current criticism is valid, Don Atkinson, vice president and general manager of female healthcare at Berlex, a pharmaceutical company, said, "We're all struggling with how to best use direct-to-consumer advertising as the best possible educational tool."

He added that he sees DTC advertising evolving towards a focus on education about a condition. And while everyone is focusing on Vioxx right now, he pointed out that it might be the exception to the rule.

"There are an awful lot of examples where there has been tremendous benefit to patients," Atkinson said, citing, for instance, the promotion of statins to lower cholesterol.

Levinson, however, thinks that advertising directly to consumers "would be a waste of money" from here on out for cox-2 painkillers in particular.

And even if consumers head to doctors with information from an ad, doctors will probably be reluctant to prescribe the cox-2s, he said. "I don't think doctors are going to be a friend of these drugs at this point," he added.

More information

For more on direct-to-consumer advertising, visit the U.S. Food and Drug Administration.

SOURCES: Paul Levinson, Ph.D., chairman, department of communications and media studies, Fordham University, New York City; FDA spokesperson; Cindy Callaghan, director, Brand Communications, AstraZeneca; Don Atkinson, vice president and general manager, female healthcare, Berlex, Montville, N.J.; Kaiser survey; Associated Press; Boston Globe
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