ADDITIONAL SIDE EFFECTS

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DIRECT-TO-CONSUMER MARKETING OF PHARMACEUTICALS MAY BE EFFECTIVE, BUT IT’S STILL NOT SAFE FROM CONTROVERSY.

You know you’ve arrived – for better or worse – when your ad is parodied by another advertiser. At least that’s how prescription drug marketers might construe a recent E superscript *Trade TV spot lampooning the spate of medicine ads permeating the airwaves and print media: An at-home, online trader’s attention is captured by a voiceover for a fictitious allergy medicine called Nozulla warning that “symptoms may include itchy rashes, projectile vomiting, the condition known as hot dog finger syndrome, full-body hair loss, gigantic eyeballs…” As the list goes on ad nauseum. The listener logs onto etrade.com and dumps his holdings in Faux Nozulla-maker Gene Enterprises.

While E superscript *Trade is poking fun, there’s serious business going on within the highly competitive, high-stakes pharmaceutical industry as companies attempt to communicate the benefits of brand-name prescription drugs to consumers. Such marketing used to be almost exclusively directed at doctors, pharmacists, and other healthcare professionals – the people who prescribe and administer the drugs. That tradition went the route of the house call in 1997, when the Food and Drug Administration relaxed regulations governing “direct-to-consumer” (DTC) advertising of drugs if certain guidelines were followed. Now, advertising is everywhere, and often includes mandatory litanies of dreadful-sounding side effects – real ones.

With the advertising has come a wave of promotional activity including direct mail, events, toll-free information lines, coupons, and Internet marketing. The industry has research to back up the efficacy of such DTC programs, and the sales and market capture of such brands as Claritin, Lipitor, and Viagra have been tremendous. Consequently, pharmaceutical company stocks have soared.

Yet this prescription for a healthier bottom line has its own side effects. Beyond typical production and media-buying costs, there are FDA regulations that must be followed and the creative challenges of making medical information palatable and credible to the average consumer. There’s also ongoing criticism from physician and consumer groups leveled at pharmaceutical manufacturers. Costs and creative can be controlled, but the fault-finding is like an itchy rash that just won’t go away.

The theory guiding DTC marketing is that today’s consumers demand more information and options when it comes to healthcare, whether it’s choosing a doctor, researching illnesses on the Internet, or deciding which medications to take. They’re not necessarily looking to eschew the traditional role of physicians and other providers, who remain trusted and held in high regard, but prefer a dialogue over the time-honored “whatever you say, doc” philosophy.

Drug marketers have been only too happy to oblige these want-to-know consumers, spending $1.85 billion last year in DTC marketing – primarily on TV, radio, and print advertising – to generate awareness for specific maladies and the brands that treat them. “But they now understand that there are other marketing tools out there they need to embrace if they want to build market share,” says John Hopper, managing partner at EinsonHealth, a joint venture of Paramus, NJ-based promotion shop Einson Freeman and Parsippany, NJ-based healthcare marketing specialist CommonHealth (a sister agency in the WPP network). “They need to build on the foundation of broad-reach awareness vehicles. Brands that want to take it to the next level need to get into promotion, into direct marketing, into interactive.”

Last summer, EinsonHealth worked with SmithKline Beecham on a consumer campaign for Lymerix, a Lyme disease vaccine. Driving the effort was a play-on-words Lyme Green Tick Team, which traveled to high-incidence areas in lime-green Volkswagen Beetles hitting events and lifestyle venues to disseminate information on both the disease and the drug. In November, Hopper directed a significant effort for Wyeth-Lederle Laboratories, a division of American Cyanamid, Pearl River, NY, and its Prevnar vaccine, which helps protect young children against pneumonia and other pneumococcal diseases. The promotion is actually a dual effort, targeted to parents at daycare centers and schools and to pediatricians through their offices.

Establishing credibility is a major concern among DTC marketers. Consumers may tolerate hyperbole about laundry detergent and peanut butter, but you’d better be on the level about prescription medicines. So an endorsement or other alignment for a drug by a medical association is prized. Wyeth-Lederle was so blessed last year when the Centers for Disease Control and the Prevention Advisory Committee on Immunization Practices recommended Prevnar for routine use in all healthy children age five and younger. (Children under two are often automatically given the vaccine, but it’s usually up to the parents to request it for two- to five-year-olds.)

That seal of approval paved the way for EinsonHealth to partner with New York City-based Scholastic Corp. to distribute printed promotional materials for parents and teachers in half of all daycare centers in the top 10 U.S. markets, as well as in thousands of classrooms nationwide. They’re also providing relevant books to pediatricians’ offices, and there’s a Web component for further information. “We’ve been endorsed by two leading daycare associations, too,” thus applying another layer of trust, says Hopper.

Madison, NJ-based Schering-Plough’s Claritin earned a different kind of endorsement by tapping into a marketing source more commonly used by makers of beer, snacks, soda, candy, and other decidedly “non-healthy” brands: sports sponsorships. In 1999, the allergy medication became the first pharmaceutical sponsor of Major League Baseball. Fans could generally relate to the product on two levels: the spring-to-fall baseball calendar spans the allergy season, and if the product helped their hardball heroes hit and field without watery eyes and runny noses, it could work for them, too.

Beyond signage at all 30 MLB ballparks and other outdoor venues, various teams, players, and cities teamed up on consumer promotions, including a “Step Up to the Plate” program with the Boys & Girls Clubs of America. By logging onto the Claritin Web site or calling a toll-free number, consumers could donate $1 for a $500,000 nationwide effort to renovate local ball fields. Players appeared at ground-breaking ceremonies to greet kids and sign autographs. The program also included a sweepstakes dangling a trip to the World Series. New York City p.r. firm Edelman Worldwide handled. (The sponsorship was secured by SFX, Inc., New York City.)

Can’t Just Play One on TV Regardless of any such endorsements, the FDA is ever-watchful that its guidelines are being followed. “We’re just choked with regulations,” contends Nancy Berkow, consumer product director at Roche, Nutley, NJ, which is working this winter with Momentum, a St. Louis-based promotional agency, on a second-year effort for its Tamiflu flu-fighting medication. “We have to be sure that when we talk about the benefits of the product, we provide fair balance,” which means spelling out side effects in a heavily scrutinized patient-package insert, Berkow says.

“There has to be a qualified balance of good and bad news,” explains Mark Perlotto, executive vp-managing director of Adair Greene Marketing Communications, Atlanta, which developed DTC advertising and direct-response promotions for CibaVision contact lenses which featured an 800-number to call for coupons and free trial fittings.

Although there are no laws mandating approval, “the FDA urges the industry to pre-clear material with its division of marketing and advertising, which can have an impact on timing – particularly for seasonal products,” Perlotto says. “It creates another layer of complexity.” And even before they reach the government gauntlet, agency-produced materials typically must pass through review boards at the pharmaceutical companies themselves.

Adair Greene recently survived the process while handling promotions for CibaVision products that required consumers to visit a licensed eye-care professional. One was a direct-response ad for contact lenses targeting teens, who upon request received printed guides for themselves and their parents, a trial lens certificate, a rebate offer, and a “tell a friend” card.

The other program was for Softcolors tinted lenses, which is more of a lifestyle purchase although it still involves a trip to a specialist. “Recognizing this, the tone and style for that consumer campaign had more the feel of a cosmetic product than a high-science sell,” says Perlotto, referring to point-of-purchase flyers delivered through the offices of eyecare professionals.

“The bottom line is that everything comes down to `ask your doctor,'” says Dan Stevenson, creative director in Momentum’s New York City office, who heads up the Tamiflu account. The onus may be on DTC marketers to effectively take the place of a doctor in explaining the pluses and minuses of the medication, but the process invariably leads back to the physician who will write the prescription or give the shot.

Many on-site DTC promotions incorporate the practitioner, employing nurses, specialists, or other professionals to answer questions or screen people for specific conditions such as diabetes, high cholesterol, or skin diseases. Stevenson’s team at Momentum had considered such tactics for last winter’s award-winning Tamiflu campaign, but ultimately opted for a more guerrilla, man-in-the-streets approach (see November PROMO or visit www.promomagazine.com for a detailed description of the effort).

Roche and Momentum have guerrilla tactics for both consumers and the trade up their sleeve for this year’s flight, which will begin whenever – and wherever – the first flu outbreak occurs. As is typical in the fiercely competitive pharmaceutical market, they declined to discuss specifics. (See your pharmacist for details.)

This year’s effort got a boost in November when the FDA gave Roche permission to market Tamiflu as prevention medication in addition to a treatment drug.

Cures for What Ails Them Tamiflu’s promotional blitz helped the drug gain a 58-percent market share last year, providing the return on investment marketers require to alleviate their own ills. And a recent study from Andersen Consulting, Chicago, titled How Much Are Marketing and Sales Capabilities Really Worth? What Every Pharmaceutical Executive Should Know, found that these sales and marketing efforts are paying out in general, too. The study suggests that a $1 billion pharmaceutical business can gain as much as $135 million in additional operating margin if it improves select sales and marketing capabilities. “Effective leverage of advertising and promotional vehicles” is one of the five capabilities cited.

The Andersen study dovetails nicely with a consumer survey conducted last year by Bruskin/Audits & Surveys for DVC ActiveCare, the healthcare division of DVC Group, Morristown, NJ, which found that 87 percent of consumers 18 and older would react favorably to traditional consumer promotions being used in the DTC category.

“Advertising may be creating awareness, but may not be enough to drive patients to ask their doctor about other drugs that treat the condition,” says Laura Mindell, president of DVC ActiveCare. Among the promotional targets gaining favor with DVC’s clients are pharmacists. “The retail channel is becoming more and more important, so manufacturers are more open to including pharmacists.”

DVC is currently working with a client and a major mass retailer to develop P-O-P materials, brochures, and other collateral directing consumers to ask the resident pharmacist about a drug. “The pharmacists love it,” Mindell says. “They want to be the neighborhood pharmacist, so the more educated they are, the more people are going to come to them.” The program completes the loop by tying to local physicians as well.

Hippocratic Oaths Those physicians, however, are not always very enthusiastic about the DTC concept. The long-standing symbiotic relationship between doctors and drug companies has pretty much been a one-to-one arrangement, with manufacturers’ salespeople making regular office visits. That personal side remains critical, so the push to go straight for the consumer has put a strain on the relationship.

“Our concern is that we feel like it really does create an issue with the patient-physician relationship,” says Dr. Randolph Smoak, president of the American Medical Association, Chicago. An objectionable scenario is when a patient who has seen marketing for a brand-name drug asks his doctor to prescribe it without discussing other classes of the same medication, the possibility of more inexpensive alternatives, or how it might interact with other drugs the patient is taking.

“The second thing is that there may not be an indication of that disease or condition,” Smoak maintains. For example, someone with the sniffles may not require Claritin, even if it does clear up their nose. Or if someone with high cholesterol asks for Lipitor, “it may be more appropriate to prescribe a change of lifestyle, including foods and exercise.”

AMA supports the idea of better-informed patients, but in terms of understanding “symptoms of specific diseases, the options of treatment, and long-term management” rather than simply as brand watchers, Smoak says. Cost is the main concern of Public Citizen, a Washington, DC-based consumer group lobbying for the FDA to write guidelines that would require DTC marketers to include information about other drugs in the same class. “Consumers need objective information,” says Larry Sasich, a pharmacist and research analyst for Public Citizen. Much of what’s out there now, he asserts, “is very unbalanced, favoring the seller. So consumers are naked in the pharmaceutical marketplace.”

The industry vociferously defends its practices, noting compliance with existing regulations, expenditures on research and development, and a trend toward increased doctor visits, which can lead to the discovery of otherwise undetected illnesses. “We believe the patient-physician relationship is, has been, and must always remain at the heart of American healthcare,” says Dr. Mike Magee, senior medical adviser at Pfizer, Inc., New York City, the largest drug maker in the U.S. and a leader in DTC marketing with such brands as Zithromax and Viagra. “Within that context, direct-to-consumer advertising does two things. Number one, it clearly has been demonstrated to get people to come into the doctor’s office years before they otherwise would. And secondly, it educates both doctors and patients simultaneously. When it’s done right, it can be a very important unifier of that patient-physician relationship.”

Pfizer has been especially aggressive in marketing Zithromax, a children’s antibiotic, by sponsoring a season of Sesame Street on PBS and funding a health magazine published by the show’s producer, Sesame Workshop. Such efforts, says Magee, will include input from physicians and general information on related diseases and treatments.

“The bottom line from a public health standpoint is that, for a fairly moderate spend – in the advertising world, at least – we’re moving the dial on the healthcare system toward prevention,” Magee says. Studies have found “that 65 percent of doctors agree that it raises awareness, and about 56 percent believe that it leads patients to treatment.”

DTC marketing is undoubtedly going to grow. So may opposition to it. To curtail any further erosion of the relationships between doctors, patients, and drug companies, Dr. Michael Fleming, speaker to the Congress of Delegates for the American Association of Family Practitioners, would like to see a cooperative meeting of the minds. “What I really hope to see is an interdisciplinary group of pharmaceutical people, physicians, and consumers come together to construct a set of guidelines to work for everybody.”

Sounds like a reasonable remedy for those itchy rashes.

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