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Cox-2 Woes Fuel Drug Ad Debate

Experts say prescription drug pitches to consumers must be clearer about risks

WEDNESDAY, Jan. 26, 2005 (HealthDayNews) -- Direct-to-consumer advertising of the cox-2 prescription painkillers Vioxx and Celebrex helped catapault worldwide sales of the drugs into the billions.

Now, with Vioxx pulled off the market by its maker and Celebrex's future uncertain, some experts say direct-to-consumer (DTC) advertising of these and other prescription drugs focuses far too heavily on potential benefits, while downplaying potential risks. The U.S. Food and Drug Administration (FDA) even went so far as to ask Pfizer Inc., the maker of Celebrex, to suspend such ads while it reviews the drug's safety data.

At the very least, experts add, drug makers need to point out possible side effects in a more clear and prominent way.

"There's the perception, certainly, that direct-to-consumer ads do a much better job at communicating benefits rather than risks," said Ernst R. Berndt, a professor of applied economics at the Massachusetts Institute of Technology and author of a special commentary on the topic in the Jan. 27 issue of the New England Journal of Medicine.

On television, radio and in magazines, Americans are bombarded with ads featuring happy, healthy-looking people given a new lease on life because of this or that prescription medication.

"They show you someone dancing through a field, like there's no possible problem with any of these medicines," said Dr. Mary Frank, president of the American Academy of Family Physicians, which represents more than 94,000 of the nation's primary-care physicians.

"These ads don't tend to talk about the potential side effects, however," she added.

Berndt, who's been studying the impact of DTC advertising for years, says Americans may be losing patience with prescription drug ads, however.

He points out that, while half the consumers surveyed in 1999 agreed that DTC ads "help me make better decisions about my health," that percentage dropped to just a third by 2002. And in surveys conducted in both 1999 and 2002, 60 percent of respondents supported the view that "advertisements for prescription drugs make the drugs seem better than they really are."

Nevertheless, a growing number of consumers appear to be evaluating blockbuster drugs through the rose-colored lens of the DTC ad. For example, one 2003 study found that patients who asked their doctor about an advertised drug usually knew much more about the drug's benefits than its potential risks.

According to Berndt, the power of mass-media prescription drug advertising lies in its "persuasiveness" -- its ability to convince consumers to approach their doctor for a particular prescription.

In fact, the drugs patients most often ask for -- anti-impotence medications, antidepressants such as Prozac or Zoloft, and arthritis drugs such as Celebrex -- are also those most heavily promoted in the nation's media, according to a 2004 study.

Some critics of DTC ads are seeking to put the genie back in the bottle, calling for an outright ban on this form of advertising. However, recent court decisions and the general ambivalence of the public toward DTC ads makes this type of "drastic action" unlikely, Berndt said.

Instead, fallout from the cox-2 debacle is stirring talk within the FDA for changes in the way DTC ads are formatted.

"The FDA is spending a fair bit of research right now trying to figure out whether risk information can be displayed more prominently, in a more easy-to-communicate way, than is now being done," Berndt explained. "For example, instead of all that fine print or long medical language, it may be replaced by [easy-to-read] boxes," he said.

Such a change might make a real difference, he noted, because one recent study found 73 percent of consumers admitted they skipped over the fine-print warnings found in magazine prescription drug ads.

Reform for TV ads would be welcome, too, Frank said.

"Do I think we need it? Absolutely. I listen to those mumbling side-effect blurbs and can't figure anything out, myself, and I'm listening for it," she said.

But Frank said simplifying the risk information panels in DTC ads won't give patients the complete risk profile of a particular drug.

"Remember, if you look these medications up online, the full list of side effects might be two whole columns long," Frank said. "What patients need to be aware of is that there's only room on a print or TV ad for the top five most common side effects."

Berndt and Frank agreed that patients need to dig further and remain critical of any drug ad that seems too good to be true.

"In the end, I hope these events with Vioxx and Celebrex will raise consumers' skepticism that, just because a drug is new, that doesn't mean it's better or safer," Frank said. "I think a healthy skepticism is always a good thing."

More information

For their position on direct-to-consumer advertising, go to the American Academy of Family Physicians.

SOURCES: Ernst R. Berndt, Ph.D., professor, applied economics, Massachusetts Institute of Technology Sloan School of Management, and co-director, Harvard-MIT Biomedical Enterprise Program, Boston; Mary Frank, M.D., president, American Academy of Family Physicians; Jan. 27, 2005, New England Journal of Medicine
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