When Emily Martin was hospitalized for emergency gallbladder surgery last summer, her doctors found that she also had acid reflux, causing erosion of her esophagus.
"My stomach was very unsettled,'' said Ms. Martin, a 26-year-old mother in Oradell, N.J. So she asked her doctor for Nexium, the "purple pill" that is the nation's most widely advertised prescription drug. "I saw the commercial and they showed people talking about immediate and miracle relief,'' she said.
It has worked, without side effects, said Ms. Martin, who pays only a $30 monthly insurance co-payment for Nexium, which can cost $200 a month or more.
Patients like Ms. Fleming are why the pharmaceutical company AstraZeneca spent nearly $260 million on television and other mass-media advertising aimed at Nexium users last year.
Approved by the Food and Drug Administration in 2001 as a treatment for severe acid reflux disease, Nexium is now so commonly prescribed for heartburn and indigestion symptoms that it has become one of the nation's best-selling drugs, with United States sales last year of $3.1 billion - even though many medical experts say that for most patients, cheaper over-the-counter heartburn remedies may work just as well.
The issue of drug advertising directly aimed at consumers was thrust into the news recently when Merck withdrew its arthritis painkiller Vioxx from the market, citing studies indicating a risk of heart attacks or strokes. Critics noted the role that advertising and marketing played in the drug's being widely prescribed to patients who might have done just as well with ibuprofen or other inexpensive over-the-counter remedies.
Vioxx, whatever its safety risks, was hardly unique as a prescription drug that became a best seller on the strength of advertising aimed directly at consumers. In the seven years since the F.D.A. lifted longstanding strictures against such ads, prescription drug advertising has grown into a $3.8-billion-a-year business. And the F.D.A. says that, despite the controversy accompanying the withdrawal of Vioxx, it has no plans to place new curbs on such ads.
Nexium is typical of the brand-building trend. No one is arguing that the drug poses serious health risks, beyond a slight chance of side effects like headaches and flatulence. Despite clear beneficiaries like Emily Martin, though, many medical experts say most patients would do just as well with various cheaper over-the-counter remedies for indigestion and heartburn, including AstraZeneca's own Prilosec - a chemically similar predecessor that no longer requires a prescription and sells for $40 a month or less.
"Nexium is no more effective than Prilosec," said Dr. Sharon Levine, an executive with Kaiser Permanente, the nation's largest health maintenance organization. "I'm surprised anyone has ever written a prescription for Nexium."
AstraZeneca, a British-based company, says that it is unfazed by the critics and that the Vioxx backlash would have no effect on its own consumer advertising for Nexium or other drugs. "We're moving forward undeterred," said Jim Coyne, a spokesman for the company, whose American division has its headquarters in Wilmington, Del. "We've got adequate support for what we say in the ads."
During last Tuesday's debate between the vice-presidential candidates, Senator John Edwards, the Democratic nominee, re-emphasized his criticism of drug advertising. Mr. Edwards said that if he and Senator John Kerry were elected, they would "do something about these drug-company ads on television, which are out of control."
The Kerry-Edwards campaign blames the ad-driven demand for pushing up spending on pricey drugs, which contribute to double-digit inflation in the nation's health care costs. Because prescription drugs are often covered by health insurance plans, many patients who take Nexium are making only a small co-payment for their prescriptions, with the insurer picking up the balance.
Megan Houk, deputy policy director for the Bush-Cheney campaign, accused the Democratic candidates of exaggerating the issue, saying that a 2002 report by the General Accounting Office showed that the drug industry spent far more providing free samples of drugs to doctors than in advertising to consumers. The ads, she said, provide useful information to the public.
"This administration's position is that all Americans need to get as much information as they can to make informed decisions, with their doctors, about their health care treatment,'' Ms. Houk said.
And an F.D.A. spokeswoman, Crystal Rice, said late last week, "There are no additional changes expected at this time in light of the Vioxx withdrawal.''
In fact, the agency is already studying a proposal aimed at further loosening the rules. It would allow drug makers to simplify magazine and newspaper ads that are now required to list detailed data about benefits and risks - often rendered in tiny type.
The change would permit the print ads to be more reader-friendly, concentrating on the most important or common side effects, for instance, by summarizing the risks in larger type, highlighted with typographical symbols.
The research firm Nielsen Monitor-Plus estimates that AstraZeneca spent $257 million last year on consumer advertising for Nexium. Of that, the biggest part went to television commercials, largely on broadcast and cable news programs, followed by spending on consumer magazine ads in Time, Newsweek and elsewhere.
That is a huge ad budget for a product of any type, larger than for brands like Olay skin-care products and Tylenol pain relievers and just below the spending for the Acura and Saturn lines of automobiles.
The spending helped raise Nexium's sales by 58 percent from a year earlier, moving to No. 7 among all prescription drugs sold in the United States, according to the research firm IMS Health.
Nexium has been such a marketing success that the current issue of the trade publication Brandweek identified the AstraZeneca team overseeing both Nexium and Prilosec as among the top 10 marketers of the year, on a list headed by the Las Vegas Convention and Visitors Authority.
Such a level of advertising can be offputting even to some Nexium patients, like Margaret Taulane, a legal assistant in Huntingdon Valley, Pa., who takes the drug for what she described as long-term digestive problems.
"I sit here every night at 6:30 and see 'the purple pill' on the news, and it's being spoon-fed to the American public like it's candy," Ms. Taulane said. "Nexium is expensive." She said her BlueCross/Blue Shield insurance plan covered her prescriptions, except for a $5 co-payment. Ms. Taulane originally took Prilosec while it was still a prescription drug, but then another doctor "switched me over to Nexium.''
The "purple pill" consumer advertising for Nexium was created by the Saatchi & Saatchi Healthcare agency in New York, part of the Publicis Groupe. The campaign was updated last month with new TV commercials, featuring the actor and singer James Naughton.
"Hey, with Nexium you just don't feel better, you are better," asserts Mr. Naughton, who had previously been featured in Jeep commercials. "And better is better."
Nick Colucci, president and chief operating officer of Publicis Healthcare, said he could not discuss specific clients or campaigns. But generally, he said, "as long as the companies are responsible in communicating," direct-to-consumer drug ads are useful because "people are demanding more information about health care, to be empowered to make the right decisions."
Dr. David A. Kessler, who was the F.D.A. commissioner from late 1990 through 1996 and left before the agency relaxed the advertising rules, said that consumer-directed drug advertising "works best if the benefits of use outweigh the risks of overuse."
But too many of the campaigns aimed at consumers are "about increasing use, which is about increasing sales," said Dr. Kessler, who is now dean of the school of medicine at the University of California, San Francisco. "In certain instances, like drugs lowering cholesterol or vaccines, that may be in the public's interest," while in others, like drugs for pain, stomach ailments or allergies, "it may not be," he said, declining to mention any specific drugs.
Many doctors are unlikely to say no to patients who come to them requesting a certain prescription drug by name, as long as it does not seem wholly inappropriate for the condition. Doctors either do not want to alienate patients who can take their business elsewhere, or are often too pressed for time under insurance payment rules to explore fully the alternative treatments.
So even if a patient with frequent indigestion might benefit from an off-the-shelf product - or by better eating and drinking habits - if that patient asks for Nexium, he is likely to get it.
"Patients say, I have a prescription benefit on my insurance, why should I pay for it over the counter?" said Dr. Mary Frank, a family physician in Rohnert Park, Calif. "Until we address that with the public, we are never going to answer the Nexium-versus-Prilosec question."
People involved in consumer drug marketing, meanwhile, are preparing for repercussions from the withdrawal of Vioxx.
Vioxx "is going to be held up as the most recent poster child for why direct-to-consumer should not continue, or continue in sharply limited fashion," said Stuart Klein, president of the Quantum Group in Parsippany, N.J., a health care ad agency that is owned by the WPP Group and creates campaigns for some other AstraZeneca drugs and for GlaxoSmithKline.
The critics will fail, Mr. Klein said, because "the series of regulatory checks, both internally at our clients and externally at the Food and Drug Administration" mean "the advertising is vetted unlike that in any other industry I've worked in."
Dr. Eric Christoff of the Northwestern Memorial Physicians Group at Northwestern Memorial Hospital in Chicago remains unconvinced that consumer drug advertising is in the public interest.
"I am not one of those doctors who goes around whining about direct-to-consumer because it somehow usurps my 'authority' with my patients," he said in an e-mail message. "The real problem is that it does promote overuse of some drugs, especially those that are newer, without the long track record of safety."
And "there is no reason," Dr. Christoff said, "despite AstraZeneca's claims to providers and patients, to pay $200 a month for Nexium, when Prilosec over the counter is $45 at Costco."
Stuart Elliott and Nat Ives, The New York Times. October 12, 2004
Copyright © 2004 The New York Times Company. All rights reserved.