DTC: The Next Phase

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Taren Grom, Editor

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In light of FDA guidances, more public scrutiny, and trending corporate citizenship, DTC advertising is subtly shifting to direct-to-education. Direct-to-consumer advertising has been mainly focused on creating brand awareness for major blockbuster products, or creating awareness for new therapeutic categories, or both. Since 1997, when the FDA relaxed regulations on how drug companies can advertise products directly to consumers, there has been a steady increase in spending on advertising prescription medications in magazines, on television, and via the radio, as well as other consumer-directed media. Advocates of DTC argue that it provides valuable consumer information. Others question whether DTC actually is having a positive impact on the health of the nation’s consumers. The industry has also had to counter the argument that DTC has been a major factor in the perceived high cost of prescription medications. According to a Kaiser Health Poll Report Survey in February 2005, most adults (90%) have seen or heard ads for prescription medications, and this share has increased since 2000 when just more than three-quarters (76%) said they had seen drug ads. Almost two-thirds (64%) who have seen prescription drug ads say these advertisements provide useful information most (22%) or some (42%) of the time. Just more than one-third (35%) say the information in ads is hardly ever or never useful. (For more information see box on page 35.) A Shifting Landscape A subtle shift to a new approach to safety-based, educational consumer advertising has begun amid controversy regarding the market withdrawal of Vioxx. Merck, the marketer of the COX-2 inhibitor, spent $81 million in 2004 on advertising, according to one industry source. Pfizer reportedly spent even more to promote rival Celebrex directly to patients, spending $114 million for ads last year. After Celebrex also fell under a safety cloud, Pfizer voluntarily agreed to suspend advertising Celebrex to consumers at the FDA’s request. Johnson & Johnson is leading the way to more safety-focused advertising. The company is setting a new direction with TV and print campaigns for its birth-control patch Ortho Evra. The ads deal squarely with safety issues and the drug’s risks as well as its benefits. One of the ads shows a split-screen image with a gynecologist on one side and a woman on the other. Sitting at home, the woman says “I’m in.” The doctor responds by saying “Let’s Talk.” The physician then proceeds to talk about stroke, blood clots, and other risks, including the impact of smoking while on the patch. She also urges women to talk with their doctors. William C. Weldon, Johnson & Johnson’s chairman and CEO, called on other pharmaceutical companies to follow J&J’s lead during his speech as he assumed chairmanship of PhRMA. “Today, patients want to be active participants in their own healthcare,” Mr. Weldon says. “But if ‘patient-centered healthcare’ is to become a reality, patients will need a base of knowledge about health and the delivery of healthcare that is far richer and more comprehensive than they have today. Here too, we must view our responsibility as larger. Over the past several years, our most powerful and consistent dialogue with consumers has been DTC advertising. DTC has drawn fire from a number of quarters. But DTC communication can be a valuable tool for educating patients and helping them to make informed decisions. Our challenge is to harness it and put it to work for the right ends. I believe we should start by recognizing that the framework we call DTC advertising may inadvertently minimize the importance and power of medicines and their risks. Our communication with patients should really be thought of as direct-to-consumer education. Education is about providing information patients need to make informed choices. It also helps patients work collaboratively with their doctors to understand the benefits and risks of the medicines they take.” Mr. Weldon also said the appropriate use of medicines should be a cornerstone of direct-to- consumer education: the right dosage of medicine, for the right patient, with the right clinical condition, for the right duration of time. The Ortho Evra ads are an example of the safety-oriented approach for prescription drugs that J&J plans to implement across the board over the next year. Still, for any pharmaceutical company, a shift from the traditional DTC ads to ones that include explicit risk-management information might frighten away some customers. Mr. Weldon says helping patients understand the power of medicine and how to use medicine wisely should be a top priority for all companies and for PhRMA. “If our industry is to retain the important right to talk directly to consumers, each of our companies in our own way must work to make DTC what it very definitely can be: a way to educate and counsel consumers in improving their health,” he says. “Mr. Weldon really drove the point home in his speech, which was that it is not about DTC anymore; it should really be about DTCE, direct-to-consumer education,” says Charlene Prounis, managing partner of FlashPoint Medica LLC. “We have to tell consumers both sides of the story and fully educate the consumer. The FDA’s guidance will impact patient communications in terms of providing more information to patients so they can manage risks better as they go forward. The movement already has begun to shift advertising from brand specific to the information/education arena. With this trend, the industry will begin to regain some level of trust so people will want to go on new products in the future.” Stuart Klein, president of Quantum, says over the last few years, there have been many new campaigns and interesting creative approaches from an advertising standpoint. “Clearly, there are now fundamental changes going on,” he says. “Some of those changes are for the better, some are not. On the positive side is the J&J Ortho Evra ad, which is an interesting approach in the new world of DTC. The ad is a very honest, straightforward exposition of what the brand’s issues are. This is very much in keeping with the way J&J is handling many of its products, for example Tylenol. If patients aren’t going to use the products appropriately, then the company doesn’t want them as customers. This is really a refreshing and honest way to go. A downside is that if every DTC ad was like this, I think there might be a bit of an effectiveness problem moving forward.” Mr. Klein adds that while it’s great to see the industry begin to address many of the concerns expressed by critics of DTC, in terms of this type of advertising, unbranded DTC represents another important option. “The real art of unbranded DTC, from an ROI perspective, is finding a way to make people aware of the condition as well as stimulating a dialogue with their physician,” he says. “This can result in an opportunity to prescribe the company’s drug.” According to Mary Cobb, president and CEO of PACE Inc., there is an important role associated with the marketing of all pharmaceutical products for “appropriate communications and education” to consumers. “Unfortunately, the term DTC has been used to refer primarily to consumer advertising or promotion, I believe it should be looked at in a broader context,” she says. “Consumers are critical stakeholders and determining their deep informational and educational needs through insight mining, and developing appropriate DTC communications, is integral to all brand communications plans.” A nonbranded appeal The trend of nonbranded campaigns, as well as a focus on more disease education even if it is branded, is starting to resonate. “There has been a lot of press about the approaches companies such as J&J, Pfizer, and AstraZeneca are taking to DTC,” says Edith Hodkinson, executive VP of sales and marketing at AccentHealth. “From my perspective, taking a more serious, educational approach to DTC communication makes a lot of sense. Taking a drug can have serious implications; there are a lot of safety issues that need to be disclosed. The challenge for marketers is to explain both the benefits and the risks clearly and effectively to patients. Nonbranded campaigns with a disease-education focus are appropriate when specifically talking about direct-to-patient communications. Because we know that television is the most powerful communication medium, it offers a great opportunity to reach patients with full sight, sound, and motion to communicate effectively both the risk information, as well as the benefits of drugs.” According to Sue Ramspacher, senior VP, Healthcare Consumer Practice, at NOP World, the company’s DTC Monitor 2004 gauged awareness of nonbranded DTC advertisements in addition to the usual brand campaigns. “Although the number of unbranded ads was limited, the research revealed a high level of awareness for the nonbranded DTC,” Ms. Ramspacher says. “This might simply be the result of effective creative execution, but it could also be the consequence of a different, more educational message resonating with consumers who recognize symptoms but have not come to grips with their need for prescription brand medication. Whatever the impetus, from an industry perspective there is definitely a transition happening from branded to more disease-awareness, disease-management, and disease-education campaigns, and I think that is a result of a combination of things. One is the FDA is certainly urging the industry to move in this direction in light of recent issues with products such as Vioxx.” According to Ms. Ramspacher, the corporate reputation issue plaguing the industry is coming to a crescendo. “I think companies recognize that they need to do something to polish their image,” she says. “They are moving away from some of the branded types of advertisements to disease-awareness as well as corporate-reputation advertisements. A couple of these types of ads that come to mind are the GSK and Pfizer campaigns. Clearly, there is a shift occurring.” Closer scrutiny of DTC communications by the FDA has caused manufacturers and marketers to be more diligent about the type of messages developed and the context in which they are delivered. “Clearly, all consumer communications should be fair-balanced and delivered in an appropriate format, but they also need to break through the clutter to effectively reach consumers — whether through advertising or other media,” Ms. Cobb says. “At PACE, we have invested in and gained significant experience in developing consumer communications to ensure comprehension of therapy, its role in controlling disease, the proper use of medications and their side effects, and how to cope or flag them to their physicians. Our model for ‘Appropriate Use/Risk Management Programs’ has been implemented for several manufacturers in different therapeutic categories. Integral to our model is a strong understanding of exactly what consumers need and look for vs. what doctors or manufacturers think they want.” Mr. Klein believes that unbranded DTC is part of a new world order. “While coming out with a branded ad certainly may benefit a pharmaceutical product more immediately, the opportunity to run unbranded advertising, from a corporate standpoint, is a smart way of doing business and can still generate a positive ROI,” he says. As the DTC landscape begins to shift, the question as to whether there will be a decline in spending has arisen. According to Ms. Ramspacher, the latest figures indicate that spending is relatively the same, although there is a shift in the types of ads being promoted. “From July 2003 through June 2004, the industry spent $4.2 billion on DTC; looking at the data through year-end December 2004 it was $4.1 billion,” she says. “While we may have to wait a bit longer to determine if there is fallout from Vioxx, Celebrex, and Bextra, there doesn’t appear to be an appreciable decline in DTC spending, but I think we are clearly seeing a shift in terms of the types of ads. Marketers have not turned their backs on TV, which accounts for the highest DTC spend; they have redirected their messages into disease awareness, disease management, and corporate image campaigns.” The industry spends an estimated $4 billion a year on DTC advertising, and many public health advocates have complained about ads showing happy people whose lives were changed by a drug. In February 2004, the FDA published a series of guidance pieces on DTC advertising of prescription drugs. These guidelines reduced the scope of the “brief summary” print requirements. In doing this, the FDA sent a clear message that direct-to-consumer advertising will remain a viable marketing option well into the future, even as it considers further constraints on DTC advertising, such as restoring restrictions on drug advertising for the first 10 years during which safety issues have not been resolved. According to some critics of DTC, this will substantially reduce the number of people harmed by hazardous drug effects. Beyond Advertising The general trend to give patients more information about the medicines they use also has encouraged the industry to expand its direct-to-patient communications. “Communication programs beyond DTC that encourage patients to be more prepared to be a partner in their own care — to ask questions, talk about their options, and leave the office with more clear direction — are being pursued to enhance the doctor-patient encounter,” Ms. Prounis says. “This is the critical time when the doctor and the patient are together, and they are interacting and exchanging trusted information. The challenge for us as pharmaceutical marketers is how to enhance that encounter between the doctor and the patient and how we can make the patient more prepared as a partner in his or her care.” An effective approach to improve the patient-physician relationship is through a customer relationship model that encompasses DTP and DTC. “Our CRM model not only creates awareness and educates on the most relevant disease/product information, but drives better care by building an ongoing relationship with the brand as a trusted provider of relevant, value-added information and support,” Ms. Cobb says. “Integral to the model is that it incorporates the right message to the right target audience. This helps consumers to self-identify, in terms of age, gender, demographics, disease state, relevance of message/information, potential/likelihood to take action, and so on. It also incorporates the right media mix to effectively reach them and engage them; the right behavioral insights to affect compliance and persistency; the right frequency and mix of messages/content and follow-up support over time; the ability to simulate a dialogue through surveys and other feedback vehicles; and measurement parameters to evaluate communications effectiveness.” As more and more patients are going online and reading information, marketers believe that it is vital to help the patient be a better partner by developing an engaging campaign. “Then we have to help physicians develop communication skills around patient interactions,” Ms. Prounis says. “When patients leave the office, they often forget half of what the doctor says, and they are not always committed to their therapy. This is the issue that we are trying to address. Compliance continues to be a problem; 30% of patients fail to get their prescription filled, and then 50% of patients discontinue their treatment within a year. As pharmaceutical marketers, we need to bridge that disconnect between how physicians are communicating with patients. These could be simple techniques, such as having the physician use metaphors that patients understand. For example, when a physician speaks to a patient about hypertension, he or she might say: ‘If you don’t take this pill, you probably will do fine. But it’s like driving a car on a highway in second or third gear; you’ll get there, but it’s just a little bit more wear and tear on the engine.'” Another trend is communicating via TV to consumers in the doctor’s waiting rooms. “We have performed research measuring ad recall and the effectiveness of communications in the doctor’s office,” Ms. Hodkinson says. “As patients sit in the office preparing to speak to the doctor, they are thinking about their health and their family’s health. They are absorbing information at a much higher rate than when they are at home. Research shows that in the doctor’s office environment, patients remember ads, and they remember program segments at a much greater rate then they typically would when viewing at home. They also retain the specific copy points from ads, and they can recite back the drug benefits and the drug risks after they have seen an ad. Most importantly they are receiving this information just before they speak with the doctor, who can answer any questions the may have. DTC advertisers really need to take advantage of that. They have patients who are paying attention; in essence this is a captive audience, and they are really listening to the messages that are being given to them just before they discuss their health with the doctor.” PharmaVOICE welcomes comments about this article. E-mail us at feedback@pharmavoice.com. DTC: The Next Phase By Taren Grom, Editor June 2005 PharmaVOICE Mary Cobb There is an important role associated with the marketing of all pharmaceutical products for appropriate communications and education to consumers. Prescription Drug Advertisements Most adults (90%) have seen or heard advertisements for prescription medications, and this share has increased since 2000, when just more than three-quarters (76%) said they had seen drug ads.How Useful Are Prescription Drug Ads? Almost two-thirds (64%) of people who have seen prescription drug ads say these advertisements provide useful information “most” (22%) or “some” (42%) of the time. Just more than one-third (35%) say the information in ads is “hardly ever” or “never” useful. In 2000, views were mixed on how well television ads present specific information about prescription drugs. Almost six in 10 (58%) said ads do an “excellent” or “good” job explaining the potential benefits of the drug, while four in 10 (40%) said they do a “fair” or “poor” job. About half (51%) said ads do an “excellent” or “good” job explaining the condition the drug is designed to treat, and slightly fewer said the same about ads’ explanation of potential side effects of the medication (45%). Trust In Prescription Drug Ads In 2005, less than two in 10 (18%) adults say they can trust what pharmaceutical companies have to say in their advertisements “most of the time,” and almost half (47%) say they can trust drug company ads “sometimes.” One-third (34%) say they can “hardly ever” or “never” trust these ads. Compared with other industries and groups, the share of the public who say they can trust pharmaceutical companies’ ads “most of the time” (18%) is about the same as for health insurance companies (17%) and HMOs (16%), but higher than the share who say they can trust lawyers’ (11%) and politicians’ (6%) ads “most of the time.” Larger shares say they can trust what doctors (45%) and hospitals (37%) say in their advertisements “most of the time.” The percentage of adults who say they can trust what drug companies say in their ads (18%) has decreased by almost half since 1997, when one-third (33%) said they could trust these ads “most of the time.” Trust has decreased slightly since 1997 for health insurance companies (24% in 1997 to 17% in 2005) and increased somewhat for doctors’ advertisements (37% in 1997 to 45% in 2005). Outcome Of Talking To Doctor As Result Of Ads Nearly one-quarter (23%) of adults say they have seen drug ads and talked to a doctor about a specific prescription medication as a result of an advertisement. The most common outcomes of talking to a doctor about a specific drug are a recommendation for lifestyle change (57% of those who talked to a doctor as a result of a drug ad, or 13% of the total population) and a prescription for the medication (52%, or 12% of total). Somewhat smaller shares say the doctor recommended a different prescription (44%, 10% of total) or an OTC medicine (34%, 8% of total), and about a quarter (26%, 6% of total) say the doctor recommended no medication. Source: Kaiser Health Poll Report Survey, “Views On Prescription Drugs And The Pharmaceutical Industry,” February 2005, The Kaiser Family Foundation, Menlo Park, Calif. For more information, visit kff.org. Stuart Klein The opportunity to run unbranded advertising, from a corporate standpoint, is a smart way of doing business. Sue Ramspacher There is definitely a transition happening from branded to more disease-awareness, disease-management, and disease-education campaigns. Consumer Response to Pharmaceutical Issues 2005 data released from the fifth annual nationwide MARS (Multimedia Audience Research Systems) pharmaceutical OTC/DTC survey reveal consumers’ most current healthcare behavior and attitudes, including their opinions regarding healthcare advertising. Several key highlights of the MARS 2005 study of over-the-counter (OTC, nonprescription) and Rx (DTC, prescription) drugs include: • 40% of consumers looked for healthcare information to make actual treatment choices. • Nearly 40% of consumers took medication as a result of seeing or hearing healthcare advertising. • More than 34% of Americans often discussed new prescription drugs with their doctors. • Almost one-third of adults in the United States believed their medical conditions limit their lifestyles. • Compared with a year ago, 10% of adults felt in worse health. • Compared with a year ago, 29% of adults felt a higher level of stress. • Almost one-quarter of Americans purchased 10 or more prescription drug products in the past 12 months. the latest study also points to definitive consumer trends: • Significant increases over the past three years in professionally diagnosed conditions for noteworthy ailments including: 10% to 15% increases in asthma, year-round allergies, acid reflux, and backache; and more than a 20% increase for depression, hypertension/high blood pressure, and high cholesterol. • The percentage of adult patients willing to ask their doctors for prescription meds they see or hear advertised has remained flat over the past four years at around 38%. • 42% of adults in 2005, compared with 36% in 2002, made an appointment to see a doctor as a result of healthcare advertising. • The percentage of adults who find health/treatment information on the Internet to be very helpful increased to 32% in 2005 from 26% in 2002. Healthcare segmentation With more than half of Americans stating that they are active in their own healthcare, the 2005 MARS Study has been able to segment the U.S. population into clusters to give more in-depth and directional analysis about consumers’ behavior that are descriptive of the type and level of their activity. • Solution Seekers: 10% of American adults are very responsive to healthcare advertising and proactively seek new solutions. • Self Managers: 14% are more likely to take action on their own and self-treat with OTC drugs. • Doctor-Led: 34% are deferring to their doctor’s judgment and advice. • The Healthy Half: More than 41% of the population claim little interest in health information since they have no obvious health problems. Source: MARS (Multimedia Audience Research Systems) is a U.S.-based survey division of KMR Group, New York, which provides in-depth analysis for media use and product consumption within vertical fields. For more information, visit kmr-group.com. Building Long-Term Consumer Relationships Pharmaceutical marketers are catching onto the importance of building long-term relationships with patients. Brand managers of both new and established brands are stepping up efforts to help patients comply with their medication regimens and are building loyal customers in the process. It is human nature to want to be understood as a complete individual. But, too often, patient-communication efforts address issues such as medication compliance from a limited viewpoint. For example, most standard communication tactics will emphasize the importance of taking medication as prescribed, as if knowledge alone will change patient behavior. What is missing in this approach is an in-depth understanding of the patient’s relationship with his or her condition, barriers to compliance, possible motivators of change, and other key factors of self-management that drive individual behavior. Without this framework, it is very likely that the compliance message will not be relevant to the patient and, therefore, will not succeed in changing behavior. Focusing on overall improvement of self-management skills has a stronger impact on compliance and persistency than a narrow medication focus. This broader approach also increases patient satisfaction and brand loyalty. There are many factors that contribute to effective self-management. At the top of the list, it is important to understand what motivates an individual to take care of his or her health and what specific barriers may get in the way. An individual’s relationship with a physician as well as a social support system can help or hurt a person’s ability to manage a condition. With respect to medication, many people have fears of side effects or unrealistic expectations that can be a factor in poor compliance behaviors. Communications that address these important issues and are tailored to the individual will improve overall self-management and medication compliance. Effective communications are the result of the collaborative efforts of behavioral scientists, market research professionals, health communication specialists, and marketing experts. And when delivering individualized communications to large audiences at a reasonable cost, technology plays a vital role. A self-management program to support patients taking, for example, a diabetes medication would begin with a thorough assessment of the patient’s baseline medication compliance and related health-behaviors (barriers, existing stress management skills, social support, doctor/patient relationship, etc.). This assessment is an excellent starting point for building a strong relationship with the patient. A patient whose diabetes is poorly managed because of lifestyle behaviors, for example, should receive different feedback than a patient who is struggling to remember to manage multiple medications. Yet the ultimate goal for both patients is to improve their ability to manage their diabetes. Whatever the disease or condition, through improved self-management skills patients can take an active role in managing their healthcare and improving their quality of life; an outcome that not only helps patients also helps their family and caregivers, which is often a forgotten audience. For pharmaceutical companies seeking a stronger and more lasting connection with patients, the natural by-products of using such programs are increased medication compliance, brand loyalty, and patient satisfaction. Source: Kevin Wildenhaus, Ph.D., Director of Behavioral Science at HealthMedia Inc., Ann Arbor, Mich. For more information, visit healthmedia.com. Charlene Prounis Communications beyond DTC that encourage patients to ask questions, talk about their options, and leave the office with more clear direction are being pursued to enhance the doctor-patient encounter. Experts on this Topic Mary E. Cobb. President and CEO, PACE Inc., Parsippany, N.J.; PACE is a full-service healthcare communications agency with core capabilities that include professional advertising and promotion, direct-to- consumer advertising and promotion, medical strategy, and medical communications. For more information, visit paceconnect.com. Edith Hodkinson. Executive VP, Sales and Marketing, AccentHealth, New York; AccentHealth is a health TV network delivered in medical waiting rooms nationwide. For more information, visit accenthealth.com. Stuart Klein. President, Quantum, Parsippany, N.J.; Quantum is the direct-to-consumer advertising division of CommonHealth. For more information, visit commonhealth.com. Charlene Prounis. Managing Partner, FlashPoint Medica LLC, New York; FlashPoint Medica’s strategy is to help brand managers identify discrete flashpoints in a brand’s life cycle to ignite growth and reshape a product’s sales trajectory. For more information, visit flashpointmedica.com. Susan Ramspacher. Senior VP, Healthcare Consumer Practice, NOP World, New York; NOP World is a global market research organization. For more information, visit nopworld.com. Kevin Wildenhaus, Ph.D. Director of Behavioral Science, HealthMedia Inc., Ann Arbor, Mich.; HealthMedia is a behavior change company that offers individually tailored self-management programs for the pharmaceutical/medical device industry that improve patient compliance with medication and treatment regimens and overall self-management of chronic illness. For more information, visit healthmedia.com.

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