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Direct-to-consumer pharmaceutical advertising, a $3.5 billion category that thrived through the ad recession and helped prevent an industry meltdown, is in jeopardy.

When Merck pulled arthritis drug Vioxx after studies showed an increased risk of heart attack, and Pfizer decided to eliminate consumer marketing after similar concerns about Celebrex, it opened the industry to attack on several fronts.

"The threat to prescription-drug advertising has moved up to code-red status," said Dick O'Brien, exec VP of the American Association of Advertising Agencies, potentially facing "a frontal assault."

The moves fueled those who have criticized drug marketers for allegedly spending more on advertising than on research and development; critics who believe there should be greater governmental oversight of DTC and those who fault the Food and Drug Administration for a poor job in the drug-approval process. It's also given a louder voice to those who believe DTC advertising sways the public into pressuring physicians to prescribe unneeded drugs.

"The combination of mass promotion of a medicine with an unknown and suspect safety profile cannot be tolerated in the future," said Eric J. Topol, a doctor at the Cleveland Clinic Foundation in an article on the Web site of the prestigious Journal of the American Medical Association. "An aggressive position going forward is necessary for not only ensuring the safety of prescription medicines, but also to restore a solid foundation of public trust."

Analyst Michael Nathanson of Sanford C. Bernstein wrote that DTC advertising "may be headed for change." While the nature of that change is uncertain, it could include anything from proposals of an all-out advertising ban to requiring DTC ads to include long lists of side effects.

Agency and pharmaceutical-company executives acknowledge the threat but believe it will pass. "In the short term, I think you'll see a less ubiquitous presence by the pharmaceutical companies," said one health-care agency president. "Long term, there's no way the drug companies, the [advertising] industry, the television networks, the magazines ... there's no way they'll let a $4-billion-a-year business slip away."

`more restraint'

"I would say the word would be `restraint,' " said one pharmaceutical-company marketing executive. "You will see more restraint in the advertising, for a lot of different reasons, litigation included."

So far, the pharmaceutical industry appears to be showing that restraint despite the looming presence of the ad world's biggest day. Only Novartis is scheduled to advertise on the Super Bowl next month, and that's for its Ciba Vision eye-care division. Last year, two of the three erectile-dysfunction drugs -Levitra and Cialis-advertised during the game.

Peter Pitts, a former associate commissioner of the FDA and now part of the health-care practice at public-relations giant Manning, Selvage & Lee, said that DTC is the "face" of the pharmaceutical business right now, and that pharmaceutical companies need to change their philosophy of advertising. "Right now DTC is following the same strategy as any package-good item," he said. "Pharmaceutical companies need to be in the public-health business rather than in the business of selling drugs. It has a potent public-health benefit, and pharma needs to rethink how it advertises."

To understand how the industry reached this point is to understand the brief but potent history of the category. Prior to 1997, pharmaceutical companies could advertise on TV but were required to disclose comprehensive information about the risks and benefits of the drug. Because that was time-consuming, and didn't exactly make for compelling advertising, few, if any, of the pharmaceutical giants advertised their prescription medications.

The rules for disclosing those side effects were relaxed by the FDA in 1997. The drug companies were still required to disclose some side effects, but were allowed to direct consumers to further information by posting Web-site addresses, toll-free telephone numbers or "see our ad in ..." references within commercials.

The move fueled the boom. DTC was a $600-million-a-year category in 1996; TNS Media Intelligence/CMR tracked the category's ad spending at $3.21 billion in 2003 (a 24% increase from 2002) and it's projected to top $3.5 billion in 2004. Currently, DTC is the 10th-largest ad-spending category in the country and proved to be advertising's one solid bastion when the recession hit hard in 2001 and 2002.

In 1994, some 39% of Americans took at least one drug daily, according to NDC Health Corp. That number is now at 44%, which some critics say is a direct correlation to DTC advertising.

From the start, it's been polarizing. DTC is credited with spurring the growth of the erectile-dysfunction drug Viagra, for example, motivating men across the country to see their doctor about a potentially embarrassing problem. On the flip side, critics point to AstraZeneca's heartburn medication Nexium as an example of marketing savvy over medicinal use. Many physicians say the "purple pill" is virtually the same as other heartburn medications, including the company's Prilosec, which is now over the counter. Nexium costs more than $4 a pill, while Prilosec is about 46ยข a pill. Yet Nexium is one of the most heavily advertised prescription drugs, and it returns AstraZeneca more than $3.4 billion in sales a year.

profit, not altruism?

Sidney Wolfe, director of health research at the Washington, D.C.-based advocacy group Public Citizen, has for several years dogged the industry, charging that it's motivated not by altruism to educate consumers and save lives, but instead by profit. The purpose of the advertising is to sell drugs, he said, much like McDonald's advertises to sell fast food. "I don't think there's any question that direct-to-consumer advertising stimulates sales," he said. "If it didn't, companies wouldn't do it."

His criticisms aren't reserved for the pharmaceutical companies alone, however. Dr. Wolfe points to what he believes is a lessened role by the FDA. He cites the decreasing number of ads the agency has asked to be pulled from the market: 157 in 1998 to just 23 in 2003.

He's not alone in the medical community. Dr. Marcia Angell, who authored the book "The Truth about Drug Companies," states baldly that "there should not be direct-to-consumer ads." Dr. Arnold Relman, professor emeritus of Harvard University Medical School, points to the Vioxx and Celebrex cases, saying there had been safety issues for years. "These two episodes are examples of what unrestrained marketing can do," he said. Both physicians are former editors of the respected New England Journal of Medicine.

Now, in the wake Vioxx and Celebrex, some are calling for a complete ban on DTC advertising. There's no question it will be a political hot button, even in a non-election year, centering on a debate about First Amendment rights and commercial free speech.

"People have been trying to hammer at this issue from the beginning and any negative information is grabbed at in order to try to end it," said Dan Jaffe, exec VP of the Association of National Advertisers. He said ANA had expected DTC to be an area of concern this year, even before the latest drug problems.

"We think DTC advertising is an important avenue of public health that provides potentially life-saving information," Mr. Jaffe added. "It also is taking place in a carefully regulated area, where doctors are double-checking and the costs of being wrong have enormous marketplace and legal consequences."

Still, some see political involvement as subtle, powerful-and inevitable.

"Senators will see the need to increase the side-effect advertising in a way that makes it impossible to write 30- or 60-second commercials," Mr. O'Brien said. "They will say `All I want is the fullest-possible disclosure of side effects' and in one fell swoop, that could eliminate a $3 billion category of television advertising."

Manning, Selvage & Lee's Mr. Pitts said he doesn't see that happening.

"It's questionable whether FDA even has the authority to ban DTC," Mr. Pitts said. "And why would you? What would it stop? People taking medicines they don't need is a point not proven. DTC is the face of the industry and is blamed for everything. But it is not the only thing. The thing that has to be changed is for everybody to have a better understanding of risk benefit."

Two recent surveys seem to support Mr. Pitts. Prevention's seventh annual survey of DTC advertising, released in November, found that "DTC advertising is an effective promotional strategy, but not so effective as to create unwarranted demand for prescription medicines." The survey noted that 32% of consumers asked their doctors about a product they have seen advertised in the past year, compared with 31% in 1997, the first year of the survey.

Also, a December poll from the Associated Press and Ipsos Public Affairs showed that the American public-including those who have taken specific Cox-2 inhibitors such as Vioxx and Celebrex-generally has confidence in the safety of prescription drugs. People are slightly more confident in the safety of prescription drugs than they are in the ability of the FDA to ensure that safety.

In addition, the Pharmaceutical Research and Manufacturers of America noted that in the past 20 years, fewer than 3% of drugs have been withdrawn from the market for safety reasons, and that 90% of prescription drug advertisements are voluntarily submitted to the FDA for approval.

And therein lies another issue: Is it DTC that critics are after, or is it the drug-approval process by the FDA?

`very rapid launch'

In November, one of the FDA's top officials, Dr. David Graham, went before a Senate hearing and said his agency is incapable of protecting the public. He also listed five drugs, including AstraZeneca's Crestor, that he believes are a danger to the public.

Dr. Graham was quickly refuted by the FDA, but Dr. John Jenkins, director of the FDA's office of new drugs, did say that the amped-up marketing machines of the pharma companies means a drug can reach millions of people far more quickly than it ever did-and millions will use it before new potentially negative side effects are known.

There is often "a very rapid launch in the marketplace," Dr. Jenkins said. "That's a setup for potentially finding the serious adverse events here after a large number of patients have already been exposed to the drug."

If Congress doesn't investigate DTC, it will surely look into the practices of the FDA. Senator Mike Enzi, R.-Wyoming, who is likely to be approved as chair of the Senate Health, Education, Labor and Pensions Committee when Congress returns this month, expects the committee to review the drug safety systems the FDA has in place.

Still, Mr. Pitts said Congress can review the situation all it wants, but the review means nothing without action.

"At the end of the day, if you want to make drugs safer, you need to give the FDA more statutory authority and more money," he said. "It shouldn't be a question of whether the FDA is bad, but how can we make the FDA better. Four words: Show me the money."

contributing: ira teinowitz

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