Wary, and weary, of 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 [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 preempt, is scrambling to voluntarily reform itself.

Just last week, Bristol-Myers Squibb Co. 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. “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The debate over prescription drug advertising has gained new momentum since the popular arthritis drug Vioxx was withdrawn from the market in September 2004 over safety concerns.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 Assnto 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% of Americans had spoken to a physician about a specific medication they had seen advertised. And 44% of those -- about 13% of the American public -- reported that they came away with the prescription they asked about.

Drug advertising has succeeded in doing many things, arguably both good and bad. Studies have demonstrated that direct-to-consumer advertising boosts the sale of advertised drugs and drives overall healthcare costs upward.

Other studies suggest that it enhances communication between patients and their physicians, that it increases the diagnosis of many serious conditions, and that it has helped remove the stigma of many illnesses, such as depression and erectile dysfunction. It may even help patients who are already on medication regimes stay on them.

A recently published study tracking TV ads in Atlanta found that, during one week in 2001, commercials for prescription drugs represented 2.3% of all ads, and that women -- who make the majority of healthcare 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.

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 healthcare 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.

These critics also worry that patients are pestering their physicians for drugs they’ve seen advertised, and that many doctors -- too pressed for time or too eager to please -- will send these patients home with the stuff they asked for. They worry that rather than telling their patients, as Schilling’s doctor did, “No, you really do have to give up the butter,” some doctors will pull out a prescription pad and write the name of the product that they themselves hear touted by the drug company’s sales force, see advertised in journals, magazines and on TV, and that their patients are now requesting by name.

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Skipping the middleman

Some, like Dr. Marcia Angell, author of “The Truth About the Drug Companies,” have argued that drug companies should not be allowed to take their appeals to the broad public. Others have called for closer government oversight and a removal of government tax breaks that help to underwrite the ads.

“More and more drug companies are treating doctors as a middleman they wish to skip,” said Sen. Ron Wyden (D-Ore.) in late May as he proposed legislation stripping drug companies of the tax deduction for advertising directly to the public. “They make a lot more if patients without medical degrees are encouraged to start writing their own prescriptions, whether the drug is the right one or not.”

Congress is considering a raft of legislation that would impose new limits on the advertising of prescription drugs. Several bills, including Wyden’s, 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.)

One legislative proposal, however, has been spurred by sheer embarrassment. Rep. James P. Moran (D-Va.) has proposed legislation that would bar the airing of ads for erectile dysfunction drugs between 6 a.m. and 10 p.m. It was no coincidence that Moran unveiled his legislation just a few weeks after the 2005 Super Bowl broadcast, during which many Americans found themselves diving for the mute button during ads for erectile dysfunction drugs.

The growing outcry over drug ads appears to have spurred increased vigilance from federal regulators as well. Of roughly a dozen warning letters issued in the last nine months, two have derailed multimillion-dollar ad campaigns, including a Dr. Seuss-inspired ad for the cholesterol-lowering drug Crestor and an advertisement for Viagra in which the “V” is shown emerging, like horns, from a man’s head, with the tagline “He’s Back!”

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.”

Although Weldon’s comments touched off a bitter debate among drug company executives, the industry has moved quickly to preempt tighter government restrictions and regain the confidence of shaken consumers. In the next several weeks, PhRMA’s president and chief executive, former Congressman W.J. “Billy” Tauzin, has said that drug companies will unveil a voluntary code of conduct for the advertising of prescription medications.

Although still under wraps last week, that code is expected to include a call for greater balance in the presentation of drugs’ risks and benefits and a heightened focus on using ads to raise awareness of treatable diseases and their symptoms.

Pitts, the former FDA associate commissioner, sees this as an opportunity for drug companies to help educate the public about the dangers and symptoms of under-diagnosed health threats such as diabetes and high blood pressure. In so doing, he says, they could restore an image tarnished by market withdrawals, concern over drug prices and public distrust of their advertising. “Right now, any congressman or senator who orates on the evil of the pharmaceutical industry gets a freebie,” said Pitts.

In many ways, consumers such as Schilling reflect the credibility gap that drug companies appear to have opened with their aggressive advertising of prescription drugs -- and the benefits those companies could reap if they would show greater restraint.

Asked if he expects better advertising for prescription drugs on TV, Schilling said he doesn’t. “Not so much on TV because they’re just hawking stuff,” he said. At the same time, he said, “I think they provide a good service to the public.” And as Schilling takes in the ads “with a grain of salt,” he hasn’t given up on the possibility that someday one will show him something he really can’t live without.

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(BEGIN TEXT OF INFOBOX)

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.

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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 firm 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.

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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.

-- Melissa Healy

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Different rules apply

In launching ad campaigns for prescription drugs, pharmaceutical companies strive to make a memorable impression on consumers. But they must be careful not to run afoul of Food and Drug Administration guidelines. The FDA does not approve ads before they air or run in publications -- a practice that some proposed federal legislation would change. Once the ads are in broad circulation, however, the FDA is required to ensure that they adhere to regulations that differ depending on the type of ad. If regulators determine that an ad is not meeting those guidelines, they can send a “warning letter” to the drug maker that details the offense (for example, an unsubstantiated superiority claim or a failure to balance risk and benefit information).

In most cases, the FDA requires the problem to be fixed before the ad can be re-aired or published again, but sometimes it directs the company to run “corrective” advertising as well. In a number of recent cases, FDA warning letters have prompted companies to abandon a campaign altogether.

What’s what in the world of prescription drugs ads?

* Product ad: If an ad names a prescription drug, it may only tout the benefits of that drug as a treatment for the use (or “indication”) that the FDA has approved. It may not discuss other uses (known as off-label uses) for which physicians often -- and quite legally -- prescribe a medication. When an ad says what medical condition the drug treats, it must also identify the medication’s major risks. The ad must further guide consumers to a place -- a printed ad, toll-free number or website -- where they can get a more detailed accounting of potential side effects. This FDA regulation is why viewers often hear a fast-talking voice-over or see small print at the end of an ad urging them to “talk to your doctor” or “see our ad” running in a general-interest magazine.

* Reminder ad: Usually a short adaptation of a longer product ad, the reminder ad is exempt from identifying a drug’s risks, but it may not identify the condition that the drug treats. This is why consumers frequently see ads that mention a prescription drug without reference to what it’s used for. Reminder ads are designed primarily to get consumers who are already on a medication to stay on it -- and to help those who have seen longer product ads to remember the drug’s name.

* Disease awareness ad: It’s not quite a public-service campaign, but the disease awareness ad aims to educate the public about the dangers, symptoms and prevalence of a medical condition -- typically one for which a drug company offers a treatment. The name of the sponsoring company typically appears, often with a website or toll-free number that will lead to product information. The name of that company’s product usually is not mentioned. Drug industry leaders have called for more of these ads, which often help drive those with under-recognized conditions to see their doctors.