Debate over drug ads

Don Schilling, a Los Angeles public relations consultant, is a savvy consumer of marketing ploys and, at 57, a man growing more attuned to the allures of pills and potions that promise to boost his health. For drug makers pitching their prescription medications directly to American consumers, Schilling, a retired Army officer, refers to himself as a "high-value" target.

They haven't captured him yet. But the drug makers keep pounding away with their ads, and Schilling admits to more than a few moments of surrender.

"I look at these and I don't know how much to believe," said Schilling. "I know it's just a blatant ad. But they're fun to watch. ... These twentysomethings that put these things together, they know the hot buttons to push."

Schilling is not alone in his wary fascination. Americans who watch TV, listen to the radio or flip through a magazine these days are bombarded with advertisements designed to pique interest in a most unlikely consumer product: prescription drugs.

Locally, doctors are seeing patients who often ask for drugs by name when they come for appointments. Dr. Janna Crosnoe of Physicians Associates in Cape Girardeau said about 1-in-10 patients makes such a request.

But at a time when the safety and cost of such medications have become hot-button political issues, politicians, patients and those who tend to the nation's health are viewing these ads with a new wariness. The result is a simmering national debate over how, when and even whether drug makers should appeal directly to American consumers.

Local pharmacists say most of their customers don't routinely ask about new drugs not prescribed for them.

As lawmakers plot new restrictions on the practice, the drug industry, in a bid to pre-empt, is scrambling to voluntarily reform itself.

Bristol-Myers Squibb Co. recently announced that it would not promote any of its new drugs directly to the public for at least one year.

Michael Guarini, a partner with the advertising leader Ogilvy & Mather Worldwide, calls this "the perfect storm" in drug advertising, as many forces gather to reform the young industry. Guarini acknowledged that much prescription drug advertising has left its sponsors open to attack.

"I hate to use the word 'slick,' but ads have become a bit too consumerized, said Guarini. "There's not enough balance between risk and result."

Peter Pitts, a former associate commissioner of the Food and Drug Administration, goes further. "People need to see that pharmaceutical companies are not only hucksters trying to sell you pills but also squarely in the public health business."

The debate over prescription drug advertising has gained new momentum since the popular arthritis drug Vioxx was withdrawn from the market in September 2004 over safety concerns. For several years, Vioxx was the most aggressively promoted drug on the market, with direct-to-consumer advertising spending reaching almost $300 million between 2000 and 2001.

Celebrex, which came under scrutiny by the FDA and is being marketed now with stronger warning labels, was a close second in its promotional budget. The evidence that advertising had caused a rapid nationwide shift to the new drugs led the Journal of the American Medical Association to warn in December 2004 that "the combination of mass promotion of a medicine with an unknown and suspect safety profile cannot be tolerated in the future."

Until the late 1990s, physicians were virtually the only members of the public who heard drug companies' pitches. But in 1997 the FDA -- which regulates the claims that can be made about prescription drugs -- issued new, more relaxed guidelines for advertisements aimed at the public. Suddenly a new form of commercial appeal -- the direct-to-consumer drug ad -- became the fastest-growing segment of the advertising business and a staple of daytime TV, talk radio and glossy magazines.

Today the direct-to-consumer advertising of prescription drugs is a $4.5-billion industry, with its own creative gurus, Internet bloggers and federal regulators hanging on every 30- and 60-second spot. Since 1997, drug makers have increased their spending on advertising almost fivefold, with television advertisements leading the way.

These ads appear to work too: A Kaiser Family Foundation survey in 2001 found that 30 percent of Americans had spoken to a physician about a specific medication they had seen advertised. And 44 percent of those -- about 13 percent of the American public -- reported that they came away with the prescription they asked about.

Congress is considering a raft of legislation that would impose new limits on the advertising of prescription drugs. Several bills would limit or eliminate the drug companies' tax deduction for marketing and advertising campaigns.

Reaction to the sudden swirl of controversy has the drug industry and its advertising partners in a hurry to react. In March, Johnson & Johnson Pharmaceuticals' William Weldon, in his opening remarks as chairman of PhRMA -- Pharmaceutical Research and Manufacturers of America, the drug industry's most prominent trade association -- acknowledged that drug advertising "may inadvertently minimize the importance and power of medicines -- and their risks."

"If our industry is to retain the important right to talk directly to consumers," Weldon warned drug makers that they would have to go beyond pitching their own products and use ads more to "educate and counsel consumers."

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Speaking directly to the consumer

Some prescription drugs are known as much for their advertisements as for their health effects. On Main Street, Madison Avenue and Capitol Hill, those ads have amused, angered and educated audiences -- and sparked heated debate. Here's a closer look at three of them:

Zoloft

The most-prescribed antidepressant in the United States is a product of Pfizer Inc., a pioneer in the advertising of prescription drugs (and the maker of Viagra).

A long-running Zoloft ad has used little cartoon droplets -- called "dots" within the company -- to explain depression. Some have accused Pfizer of trivializing the disease with the widely recognized cartoon characters. But Pfizer says the genderless, ageless "dots" help get beyond the stigma and denial that surround depression: Viewers seeing them are less likely to dismiss depression as a disease that only affects people of other ages, ethnicities or gender. And Pfizer says the ad's simple rendition of depression's symptoms and its explanation of depression as a chemical imbalance -- not a character flaw -- have driven countless sufferers to be diagnosed and get help. In the last three months of 2004 alone, say company officials, 2.7 million Americans contacted their physician as a result of seeing the ads -- and almost half were newly diagnosed with depression or anxiety disorder.

The "dots" ads have begun to change, incorporating new scenarios. And Pfizer has added a highly straightforward "disease awareness" ad to its arsenal. In it, Lorraine Bracco, who plays a psychiatrist on HBO's "The Sopranos" and is herself a depression sufferer, describes the symptoms of depression and urges people who think they may suffer from it to talk to a doctor. It appears to be a direct response to a recent appeal from the new president of the pharmaceutical industry trade group, PhRMA, for drug makers to use their advertisements to educate consumers and not just to hawk drugs.

Crestor

The cholesterol-lowering drug, a product of AstraZeneca USA, has had a rocky ride into public consciousness. The company's launch advertisement featured a rhyme inspired by Dr. Seuss and whimsical, rapid-action images to match. "When Crestor performed in a head-to-head test, its lowering effect was clearly the best," the voice-over said. The FDA was unimpressed with AstraZeneca's poetry, and last March issued a stern warning letter, telling the company it was making false superiority claims.

Crestor also was attacked by the watchdog group Public Citizen, which petitioned the FDA to ban the drug out of concern for safety (the agency declined).

A new Crestor ad gets serious. Actor Mandy Patinkin delivers a straightforward account of Crestor's effectiveness in driving down high cholesterol. In equally plain talk, he outlines Crestor's potential risks as well. AstraZeneca Chief Executive David Brennan says the ad "balances between safety, education and brand," selling a product but doing so in a way that aims to educate viewers. "That's clearly the direction things are going," he adds.

Levitra

You know her -- that sexy forty-something pitchwoman, lounging on the couch with her neck-nuzzling honey, who touts the "quality sexual experience" that Levitra delivers. Unlike the makers of rivals Cialis and Viagra, the trio of drug companies that make and market Levitra (GlaxoSmithKline, Bayer and Schering-Plough Corp.) uses a female voice to appeal to erectile dysfunction sufferers -- and their partners. In recent months they've also put more clothes on her; Levitra's pitchwoman used to wear "her man's" shirt, and seemingly nothing else. Unlike many prescription drug ads, the Levitra commercial makes a bold play at market share as well, urging those already diagnosed with erectile dysfunction to "switch" to Levitra's "strong, long-lasting" experience. (Studies show that pharmaceutical ads generally boost sales for a broad class of drugs but don't get many consumers to switch from one to another).

Makers of erectile dysfunction drugs spent some $400 million in 2004 to advertise them. U.S. sales totaled nearly $1.2 billion. But the ads' frank talk has prompted legislation that would forbid their airing during daytime and family-hour programming.