Birmingham News, July 11, 2005

Melissa Healy, Los Angeles Times

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 (drug advertisements) 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.

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.

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 (they've become) a bit too consumerized," said Guarini.

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The debate over prescription drug advertising has gained new momentum since the popular arthritis drug Vioxx was withdrawn from the market in September 2004 over safety concerns.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.

AMA warning

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.

A recently published study tracking TV ads in Atlanta found that, during one week in 2001, commercials for prescription drugs represented 2.3 percent of all ads, and that women - who make the majority of health care decisions for their families - and the elderly are the prime targets. The authors, from Emory University School of Medicine, estimated that an average viewer was probably exposed to more than 30 hours of drug ads in 2001 - about a third of them for drugs available only when prescribed by a doctor.

Tempted to ask

Schilling says he finds the ubiquitous advertisements for the erectile dysfunction drugs Viagra, Cialis and Levitra clever and a bit enticing. Though he does not suffer from the condition, he acknowledges, "I'm tempted to go to my doctor and say, `Hey, doc, lemme try this out.'"

A few years ago, shortly after he learned that he had high cholesterol, Schilling remembers seeing an advertisement for a cholesterol-lowering drug and thinking, "Wow, there's medicine for this! Maybe I don't have to give up the butter!"

Reactions like these have prompted concern among physicians, federal health officials and those - including lawmakers - who have watched in alarm as the cost of health care has risen faster than at any time in history. They fear that advertising prescription drugs to the public encourages the widespread use of costly brand-name medications, often by people who do not need them, who should not take them, or who could use older, safer and cheaper treatments for treating their conditions.

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.

Another would create an FDA office of drug safety that would, among other tasks, review and approve advertisements before they reach the public if a medication is new to the market, if it is considered high risk, or if its safety is not the subject of ongoing studies. (Currently the FDA requires that prescription drug advertisements be submitted for review at the time they go into public circulation.)