The average drug loses 36 percent of its sales a year due to poor adherence. And one-third of prescriptions are never even filled. As riveting as these numbers are, they are no surprise to anyone in pharma. 

Despite efforts to reach out to patients and physicians through new technologies, increased online information, and adherence-driven DTC advertising, the industry has yet to develop and execute an effective adherence strategy. 

There are many reasons why individual patients do not adhere to doctors’ orders-including cost, fear of side effects, and lack of belief in the need for the medication or its effectiveness. 
  Studies show that 20 percent of patients will be non-adherent no matter what a physician or pharmaceutical company does, and 20 percent of patients will always dutifully follow their doctors’ orders. That means an opportunity exists to reach out to the remaining 60 percent of patients who can be influenced. 

To be effective, an adherence strategy must be responsive to an array of patients with different habits and medications, while providing information, encouragement, and support until adherence becomes reliable. It must focus on the needs of specific patient segments and even specific pharmaceutical brands in addition to adjusting for the disease state (for example, breast cancer) or broad therapeutic area (for example, oncology). It also should include three key elements-education, motivation, and monitoring. (Most plans use one or two, but not all three.) 

The bottom line: An effective plan is one that allows a physician to help a patient adhere to the medication. It further enables a physician to know and to understand the challenges his or her patient faces. Then and only then can something be done. 


  One path to understanding what a patient is going through is simply to ask:  What do you feel about your current medication experience?  This can be done in depth by giving the patient a questionnaire prepared by a third party at the behest of the brand’s company. After processing the patient data, it is shared with the doctor. The information covers the patient’s current experiences (as well as his or her past adherence behaviors). The physician can then assess the information and address the patient’s concerns. If there are problems, the questionnaire data will help the physician to quickly address them. And even if there are no problems, it gives the physician a way to predict and to influence future adherence issues the patient might experience. 


Each program originates with the sales rep who recruits the physician. The physician then invites the patient to participate. The patient enrolls and provides baseline information. As the cycle progresses, the patient continues to communicate, via questionnaires, his or her experience with the brand, which in turn is processed and fed back to the brand team, which supplies them with consumer data and insight into brand performance. The physician also receives individualized patient feedback reports. And, ideally, by way of this back and forth, the patient and the physician establish a more effective communication. 


  The frequency of the collection and dissemination of information should be shaped by the treatment and the specific brand of medication. For instance, if there is a known point of adherence drop-off for a particular medication-a point at which a patient may experience unpleasant side effects-the strategy can take this into account and address patient concerns prior to that point. 

A pharma company also can use the ongoing communications with  patients to identify new educational opportunities and to share that information with prescribing physicians. 


  This give-and-take of information between pharma companies, physicians, and patients can have the desired effect of making patients feel like active participants in their treatment. It can also enhance their feelings of trust and responsibility. 

Having patient treatment monitored, providing information, and having it returned to physicians who then review and discuss it with their patients can be an incentive for patients to make a commitment to a therapy, and adhere to  physician requests. 


  Similarly, the regular collection of patient feedback can help physicians be more informed and engaged in their patients’ care, as well as helping patients to adhere to their prescribed treatment regimens. The result: an increased number of positive treatment outcomes. 

Additionally, the collected data gives physicians valuable information and insight into patient experiences with brand-specific drugs. This can increase the likelihood of those physicians prescribing the medications again. 

Improving adherence extends beyond stemming the flow of lost pharma revenue. Individuals who are not compliant with prescribed medication regimens are estimated to cost the United States between $13 billion and $15 billion annually (Mistry & Sorrentino, 1999). The hope is with healthier, more adherent patients who are more involved in their care, those costs will dwindle, as will the costs that are handed down to the consumer. Adherence then becomes a win-win situation for many. 


A pharma-sponsored patient feedback adherence program was implemented to supplement the education patients receive at a physician’s office about cholesterol management and the role of a particular medication. It included questions and feedback geared specifically toward increasing adherence to the medication, diet, and exercise. 

Designed by InfoMedics in 2006, the survey included 6,800 patients who were asked about their understanding of the condition, and of the prescribed medication. They also were asked about compliance, satisfaction, and their intent to continue the medication. Their prescribing physicians received feedback reports summarizing patients’ responses. 

Independent analyses conducted by IMS Health revealed participants in the program increased their adherence to the medication by 17 to 27 percent, relative to similar patients who did not participate in the program, depending on where they were in their treatment. The smallest difference (17 percent) was observed among patients filling their first prescription. The largest (27 percent) was observed among those filling six or more prescriptions. A new prescription increase of 17 percent was seen among physicians with participating patients, and an estimated $7.4 million in incremental revenue generated by participating physicians 

Stanley Wulf, MD, currently serves as the vice president and chief medical officer of InfoMedics, Inc. 

Articles

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To be effective, an adherence strategy must be responsive to an array of patients with different habits and medications, while providing information, encouragement, and support until adherence becomes reliable.

Take Your Medicine: A Prescription for Brand Growth

Between Congress, the courts, and consumers, it has been a rocky year for DTC. By summer's end, several pharmaceutical giants had agreed to delay the consumer advertising of new prescription drugs for six months (see "Branding Under Fire").

Many of the current DTC ads seem lacking in pizzazz (the new Lipitor ad for one). Gone are the iconic images—bumble bees, beavers, and moths—that made the old ads stick in a viewer's mind. A subtler breed of marketing that skirts regulations altogether is emerging. One approach is not to name the brand at all—Pfizer's Chantix ad that aired during the Olympics was about quitting smoking. Merck's Gardasil campaign hawks Char4life bracelets. And a rooster for Sanofi Aventis' Ambien involves 15 seconds of a crowing rooster that urges the viewer to 

. The goal is to get customers to the brand's Web site—proven to be the most successful form of online marketing (the rooster got 400,000 Web site hits in the first seven days it aired).

By far the most subtle, even stealth-like, marketing approach is to pay to have your brand mentioned on a TV show (see "Detailing Dr. House: Promotion or Risky Prescribing?").

For less covert and more strategic marketing tactics, we asked the heads of the top independent advertising agencies to share their ideas (see "Branding Under Fire"). They saw the moratorium as an opportunity to educate doctors and to create deeper more direct dialogues between brands and consumers. "We should give physicians, patients, and consumers credit that they can discuss the issues, think for themselves, and make appropriate choices," said Al Topin, sounding like a breath of fresh air.

special projects editor. She can be reached at 

Introduction

A DTC backlash is forcing branders to come up with new marketing approaches. Some are better than others ... much better

Introduction: Evolutionary Branding

Stretched in-house resources and the need for specialized services like online marketing have pharma companies relying more and more on outside advertising agencies. Agency spend represents a significant portion of overall promotional budgets. At the same time, cost controls put pressure on agencies to deliver promotional materials on shorter timelines while having to work with increased regulatory issues. All of which means that it is important to manage your relationship with your agency. But how? 

Just as manufacturing operations rely on standard operating procedures (SOP) to help achieve medical, regulatory, and legal compliance, the side of pharma that manages brands should adhere to smilar, set policies for working with outside agencies. Among the clients we work with, two-thirds have codified guidelines that set clear and measurable goals when it comes to managing agencies.  

Having such guidelines in place can improve the ability to forecast brand needs, adjust expectations of brand results over time, help negotiate rates, audit agency performance (including agency-brand team interactions), and address compliance concerns.  

Ideally, once companies make the investment in time and money to develop standards for agency relationships, they will also take the extra step to make that information available to all relevant parties via appropriate information channels (e.g., company intranet, Web sites). 

Relationships work best when partners have a sense of equality, their perspectives are valued, and they are part of a team. But how do you foster a climate of collaboration when the group is a disparate mix of marketers, account managers, technical specialists, and creatives—all with different perspectives and objectives? 

This is where the Commercial Operations arm of your company can play a critical role in managing agency relationships. It is a well-known paradox that creativity thrives in an atmosphere of maximized business productivity. For instance, when assets are easily recordable, retrievable, and reusable by everyone, creative types become more creative, managers become more innovative, and team leaders have more control managing money, time, and people. 

Commercial Operations personnel bring a combination of management expertise and technical savvy to brand teams, which are typically green. (On the average, a pharma brand team manager stays on the job for 18 to 24 months.) On the agency side, senior personnel may remain in place longer, but members of the account teams—the people who perform the hands-on work—also change every year to two years. 

Comm Ops, on the other hand, typically has lots of experience working with numerous vendors. By bringing them on at the outset, during the agency selection process, you can take advantage of their ability to identify best practices and avoid the mistakes of the past. Their professional background qualifies them to recognize which agencies have the right credentials for a given assignment.  

Once a relationship is established with an agency, Comm Op staffers can bring their analytical expertise to bear. They can assess (with appropriate metrics) how well agencies are meeting stated objectives and expectations, and how well they're operating within the pharma company's overall culture.  

By providing comprehensive, objective evaluations, Comm Ops can save time and money, and make the job of agency management more efficient. On the agency side, this structure actually helps offset the problems that often can occur when marketing, public relations, and medical education agencies feel as if their creative, thought-driven services are being treated as interchangeable commodities.  

Some of the tools and approaches Comm Ops can bring to the table include: 

    Mechanisms are put in place to automate and streamline promotional review and approval processes, which results in faster turnaround of promotional materials.  

Designing and creating a repository to collect, store, and retrieve digital assets for repurposing helps to optimize workflow and enrich the work environment. 

Automation can be used for marketing resource management to facilitate techniques such as exchanging notes, annotations, and other materials needed in the promotional review process. (The aim here is to reduce cycle time in the promotional supply chain for all channels.) 

 These can be used to hone messages and target strategies, factoring in competitive responses, market reactions, legal and regulatory issues, and managed healthcare environments. 

 These techniques can be used for rigorous examination of the promotional supply chain. They can also identify opportunities to reduce cycle time, reduce errors, and improve predictability of materials flow. 

 Commercial Operations can help in providing content for training and orientation programs. Again, the frequent turnover of brand teams makes it all the more important and useful to have robust training methods in place.  

 The creative use of compensation can provide an excellent tool for managing agencies and encouraging optimum performance. Companies can reward agency partners for proposing innovative approaches, beating deadlines, reducing turnaround time, and generally exceeding expectations. 

The same concept holds true for underperforming agencies as well. One large-tier company, for example, realized a 5 percent reduction in agency fees because predetermined objectives weren't met. 

While it is understood that professional services such as advertising and public relations can't necessarily be treated as a commodity, the nuts and bolts of what's been contracted for, such as developing materials and delivering them on time—or ahead of time, are easily quantified and therefore can be evaluated using objective criteria. 

CROSSING THE T'S ON YOUR AGENCY RELATIONSHIP

When establishing a set of formalized procedures for your brand team, it is important to remember to include processes for: 

Experienced managers have a response plan in place. As part of your set operating procedures, an escalation process should be in place in case a dispute emerges between an agency and client. This will enable the matter to be bumped up the marketing ladder for resolution. 

Additionally, if an adverse market event should occur, a clear chain of command should be in place, along with a specified process to follow. This will enable appropriate decision makers in senior management to be notified before a problematic situation becomes critical. Examples include: receipt of a warning letter or notice of violation from DDMAC, a product recall, damaging clinical information, inventory stockouts, etc. 

 Companies in which separate divisions are responsible for distinct therapeutic areas pose special challenges. For example, an oncology franchise might want to select multiple agencies with proven expertise in different areas within the category, which might result in numerous agencies of record. It may make sense for oncology to select one ad firm for a breast cancer treatment and another for its prostate cancer drugs. This requires a set of operating standards that accommodate the situation. There is no one-size-fits-all framework. 

Your standard operating procedures are sound if they help with:  

				•Optimization of brand resourcing, both quantitatively and qualitatively			

				•Minimization of agency compliance-related issues   			

With careful forethought, pharma companies can develop winning relationships with their outside agencies, benefitting the brand and, ultimately, the bottom line. 

Pharma is looking to advertising agencies for more support, but companies are also under financial pressure, which in turn puts pressure on the agencies. Here are some ways to ease the situation

How To Manage A Winning Agency Realtionship

You have a plan for your brand. You've even updated it every year since launch. But here's the question: Have you updated your view of your patients since launch? In too many cases, brand managers never take that crucial step. They may revise their strategy and tactics, but they're doing it based on a view of the patient that was established late in clinical trials.

When that happens, crucial questions remain unanswered: Do you know how various patient segments are responding to your product's current positioning? This is an increasingly vital insight given the rise of consumerism and the role that patients play in treatment decisions.

What about how the treatment tracks with patients' disease progression? If you don't know, you may be overlooking unmet needs that can be addressed with additional clinical investment.

And, can you tell if your product is winning new business only to lose it through product switching or poor patient persistence?

Attention to detail like that can make the difference between holding one's own in the market and breaking away from the pack. With an updated understanding of what type of patients use a brand under what clinical conditions, you can discover opportunities that can invigorate even a mature brand.

In the past, the only way to segment patient populations according to their clinical characteristics was through primary research. Today, we have information sources containing anonymized patient-level data (APLD) to help define the needs of various patient segments and identify patterns in how products are used. Anonymized patient-level metrics are not new, but they've largely been overlooked or underutilized. With APLD, companies can rely on actual behavioral data to profile the types and groups of patients who receive specific treatments.

APLD comes in several forms. Health plans' claims data can be used to define the unmet treatment needs of patient segments and provide an evidence-based view of the treatment context for millions of de-identified patients, tracked over time. Data include details on patients' pharmaceutical therapy, diagnoses, testing, medical procedures, and hospitalizations, leading to a complete picture of patients' healthcare experiences.

Another source of APLD, longitudinal prescription data, tracks dispensed prescriptions for millions of de-identified patients over time and ties that information to prescriber-level details—providing deep insight into how drugs are used in real-world settings.

Insight into how therapies are used—and not used—in the real world can help focus strategic thinking and enable more deliberate marketing decisions over the life of a pharmaceutical molecule.

Quite often, the process unearths opportunities that may not otherwise have surfaced. For instance, a company might learn that a meaningful subsegment of the patient population with a particular comorbidity profile is much more apt to be prescribed a competing product. The company could then assess the value of conducting further clinical work to prove the product's degree of efficacy within this subpopulation.

Let's look at an example: A segmentation analysis of patients diagnosed with type II diabetes showed four patient types having distinctly different clinical profiles. One segment was made up of older patients whose condition was well managed. These patients were frequently treated with combination therapies, and also tended to be on cardioprotective therapies.

This information suggested that to increase utilization within this valuable cohort, the brand team should:					

Reach this segment with direct-to-consumer advertising that emphasized the value of medication in maintaining control over diabetes

View patients in this group as ideal candidates for therapies that combined new agents with older therapies

Consider opportunities for bundling or copromoting its products with a statin or ace inhibitor

Patient flow models (also often called patient funnels or treatment cascades) are a useful tool for revealing where patients enter the healthcare system and studying their treatment progress. In quantifying the number of patients in each part of the pathway, and in displaying patterns in real-world clinical practices, patient flow models clarify where marketers should be redirecting their efforts.

For example, if an unusually large number of patients are diagnosed but remain untreated for a given condition, a company might want to step up direct-to-consumer education, stressing the importance of therapy in managing the disease. Or, if it appears that diagnostic hurdles are hampering the administration of treatment, a company might support diagnostic innovations.

Patient flow models can also highlight how often physicians deviate from treatment guidelines, how often they switch patients from a given product, what they are switching them to, at what point in the treatment progression patient persistence drops off, and so forth. In each instance, such insight would suggest to marketers ways that they might improve treatment rates.

The conceptual patient-flow model combines APLD from health plans' claims databases with data drawn from longitudinal prescription databases. If this model were populated with actual patient counts for a chronic condition, it might reveal that a brand was generally being used as second line therapy—an unwelcome finding if the product were approved for first line therapy. Knowing this, the brand team could investigate the cause and then build corrective actions into the marketing plan to create a better match between the product's indication and its actual use. Furthermore, the model would provide significant insight into the type, timing, and locale of dynamic treatment decisions that were being made, giving the brand team the ability to create tactical plans to address areas of concern.

When brand managers invest the time to better understand the clinical profiles of patients and where they are in the treatment pathway—leveraging insights now available with APLD—they are often rewarded with a fresh set of opportunities for their brands. Innovative marketing tactics developed to capitalize on these discoveries help fuel brand growth, "maximizing the molecule" over its lifecycle.

 is director, Launch and Brand Management, and can be reached at 

 is senior principal, IMS Consulting, and can be reached at 

With an updated understanding of what type of patients use a brand under what clinical conditions, marketers can find ways to invigorate even a mature brand

Maximize Your Brand: Uncovering Growth Opportunities

				Choose one: You're leading a big brand team with deep pockets and thousands of reps in the field. Or maybe you're at a mid-tier drugmaker with unique experience in a specific drug class and therapeutic area. Or you have a terrific new biologic that's working wonders for your patients. Question: What do you all have in common? Answer: drugs and a ticking clock. 

Brands have a finite amount of shelf life before something comes along to upset the apple cart. If you haven't made the most of your particular asset when the next-generation drug launches —or generics suddenly appear, or the reimbursement paradigm changes—options disappear as quickly as market share. 

Everyone loves the shortterm. In Phase III, at launch, in the rush to grab market share, and later as brands duke it out with emerging competitors, teams rightfully focus on near-term results. The challenge is keeping a firm grasp of the long-term picture. As next quarter turns into next week, it's easy to lose sight of strategies meant to carry a brand through its entire life. Plans fall by the wayside—or never get made at all—and teams face the prospect of managing a crisis with no clear strategy and few useful tools. This situation happens all the time for older drugs whose original brand leaders, long gone, didn't forge plans to extend product life when a few extra months could mean hundreds of millions of dollars.  

Lifecycle management is not new. Companies have been involved in LCM activities for decades. Lacking, however, was any formal resource allocation or pipeline realignment associated with the function. Now that companies are no longer launching blockbuster after blockbuster, they must put in place a LCM plan for the long haul to concentrate on maximizing the value of every brand in their portfolio.  

LCM isn't a magic bullet for late-life issues. It is, however, a toolbox for executives trying to foresee all the challenges their brands will invariably face. As pipelines get dryer, that toolbox is getting more and more formal. In a survey of large drug companies, half had taken steps to build formal LCM groups. Those companies are working to integrate lifecycle planning into every step of project development and brand management.  

 For most drugs, the time to start hatching long-term plans is yesterday—or the day before. Formal lifecycle planning reaches all the way back to preclinical development. Patent- filing strategies, clinical program planning, and formulation decisions will have direct impact on brands 15 to 20 years down the road. It requires dedication, discipline, and a willingness to look beyond tomorrow. No matter what situations they face now, marketing groups need to be thinking ahead—and doing it as soon as possible 

As a drug moves through various lifecycle stages, LCM executives must constantly change their priorities. At each milestone, LCM teams need to focus on different tactics to pursue. Although a new stage in a product's life requires LCM teams to execute the task at hand, executives must always remember how each LCM activity fits into the big picture.  

LCM priorities during early-stage development can change with each development phase. Once the drug launches, each new year brings patent expiration that much closer and, therefore, brand teams will need to focus on preparing for that milestone. Even after patents expire, companies still have options to maximize their drug's value.  

For the most part, funding for LCM activities is tied to individual brands. In a survey, 86 percent of companies tied LCM budgets to individual brands while the remaining 14 percent funded LCM from other sources. It makes logical sense for LCM activities to be funded via brand budgets because the activities that are performed are intended to have a positive impact on a specific brand. 

The remaining 14 percent of study participants, who do not tie LCM funds to brand budgets, provide LCM funding through marketing or R&D. While these companies are a minority, they nonetheless all have a system in place that provides funding for LCM-focused activities. 

Regardless of where the funding comes from, the challenge is to attain sufficient resources to provide adequate LCM support for a brand. An interviewee in the survey gave a prime example of this all-too-common struggle for resources: The LCM team member had to fight to get funding for a $35,000 white paper, which ultimately saved the company upwards of $35 million from a competitor's drug. As the interviewee noted, it would not have mattered if he/she was asking for $2 million to write the white paper—either way it was going to be an uphill battle to secure the necessary funding carry out the LCM tactic. 

To overcome the challenge of winning necessary funding for LCM, a Company F executive suggested that LCM team members go to high as they can within the organization to make sure that upper management not only understands LCM and its benefits, but also tries to sell the process of LCM as much as possible. Achieving buy-in from upper management is critical in gaining financial support for LCM, as well as cultural support for developing an LCM-conscious organization. 

Although there are always other market factors at play, companies that take the time to analyze the benefits of investing in specific LCM tactics have a better idea of what type of return the tactics might produce. As LCM teams and functions begin developing LCM strategies and objectives for a brand, it is typical for them to explore strategies that will offer the best payout for a brand. It figures that LCM teams that are able to provide evidence-based research on the resource implications of investing in a specific LCM tactic are in better position to request and receive adequate funding for the LCM initiative. 

For branded pharmaceutical companies, the greatest advantage they have is the market exclusivity afforded by their patents. In their race against the clock, teams consider all the tools available and assemble them into a viable LCM plan that considers different scenarios and contingencies at different points in their drugs' lifecycles. 

Although advanced groups start formal planning in Phase II or III, it's not too late at launch or shortly thereafter. LCM tactics commonly employed during a brand's peak sales period show that drugs enjoy a long stretch of patent protection and, ideally, sales that continually climb or, at the least, gently plateau.  

Survey data compared tactics' average ROI, implementation time, and investment (the size of the bubbles). At this point in time, the ability to reposition a marketed product delivers a cost-effective shot at delivering increased revenue. Options such as new formulations and indications are more expensive and time consuming, and they get mixed reviews in terms of ROI. Less expensive options such as patient programs are relatively cheap and effective. These tools are available to nearly all brands. The trick lies in integrating them into a cohesive plan.  

Repositioning, for example, is not a new concept; it's a brand's response to market realities. Based on doctor and patient views, clinical data, and competitor activity, teams alter promotions to make the most of their products. In concert with other long-term plans, a well-conceived strategy can shift a brand's fortunes and lay the groundwork for years of success. 

On this front, King Pharmaceuticals carved out a niche in the sleep-aid market by repositioning Sonata. Compared with Ambien, the drug delivered fewer hours of sleep—a perceived deficiency in this class. King, however, turned the situation to its advantage by proclaiming that "It's not too late for Sonata," and encouraging Sonata use when it was too late for a full eight hours of sleep. In a more dramatic move, GlaxoSmithKline bought OTC rights to Roche's orlistat and turned an underwhelming prescription drug into OTC blockbuster Alli. 

As time goes on and a drug ages, the brand faces a different set of challenges along with different later-life options. As patent protection nears its end, R&D-based options tend to offer companies the best chance to retain revenue, but they also require significant investments of time and money. 

Effective transitions to next-generation drugs are the holy grail for companies seeking to replace an older brand with a new one. AstraZeneca's switch from Prilosec to Nexium is a longstanding benchmark for success on this front. More recently, Shire launched Vyvanse to build on its Adderall franchise. Although Adderall XR's patent was set to expire in 2009, Shire launched its new brand in 2007. The time cushion provides enough time to ensure patients make the transition before generics appear. 

It is never too early to start implementing a life cycle management strategy, particularly with the long lead-times for the development of a pharmaceutical product. 

Brands across the industry pursue these options every day. The difference lies in planning for late-life success and following a cohesive plan— not resorting to a jumble of desperate tactics as damage control.  

That kind of strategic planning requires time. Efforts to improve formulations and drug delivery, for example, start in clinical testing. Next-generation products take years to either develop or acquire. Even small tweaks to promotion strategies require mastery of market, clinical, and competitive data collected over time—and that's not including complete overhauls that reposition drugs in their markets. Even then, there's no guarantee that any particular strategy will work. There's at least a chance that it will, however, with advance planning.  

With some planning, companies can advance their LCM processes, strategies and structures. Teams that take the time to map out their brands' options—both for today and tomorrow—will be thankful in the long run. 

, Research Manager at Cutting Edge Information, can be reached at 

What companies need is a LCM plan for the long haul that's strategic, funded, and includes a pipeline realignment process for every stage along the way. And they need it now

Lifecyle Management Planning For Yesterday

GUIDE TO BRANDING took a look at the state of direct-to-consumer (DTC) marketing 10 years after the FDA relaxed its guidelines on advertising pharmaceuticals in broadcast media. The industry's 2006 DTC expenditure was $4.5 billion, representing a 220 percent increase over the 1997 expenditure of $1.4 billion, according to IMS. And while ROI is not always easy to determine, the median return on investment for brands that employed DTC advertising in the IMS normative database was $2.20 for each dollar invested. 

There was, however, a cloud on the horizon that threatened to change the future of DTC promotion—the pending legislation in both the House and Senate that would authorize FDA to screen all advertisements before public release and impose a multiyear moratorium on TV advertising after a product had been approved for marketing. 

Well, the future is here. And between the courts and Congress, DTC's storm clouds have only gotten thicker. While FDA's plan for premarketing review of television advertisements legislation was shelved in 2008, it is expected to rear its head again. The agency's 2009 budget includes a telling increase of $14 million for DTC television ad review.  

As for a multiyear moratorium on DTC advertising, that too remains a suspended threat. In June, Merck, Schering-Plough, Johnson&Johnson, and Pfizer agreed to a voluntary six-month moratorium on advertising new drugs to consumers.  

The move came in response to requests from House Energy and Commerce Committee Chairman John Dingell (D-MI) and Rep. Bart Stupak (D-MI), who heads the committee's oversight and investigations panel. 

Dingell and Stupak sought a two-year voluntary moratorium on DTC advertising, and possibly even longer in the case of drugs for which not all studies have been completed. The lawmakers also asked for limits on the use of doctors in ads and agreement to Black Box warnings on ads, if requested by FDA.  

The drug companies agreed to follow AMA guidelines regarding use of doctors and actors portraying doctors, and not to advertise off-label uses in DTC ads. In addition, the Pharmaceutical Research and Manufacturers of America (PhRMA) agreed to hold further meetings with the committee. 

Nancy Beesley, HC&B Healthcare Communications			

The drug companies informed the committee that the six-month moratorium only formalized an industry practice already in place—to educate doctors before moving to consumer communications. "We have adopted internal guiding practices on direct-to-consumer advertising for prescription drugs that requires that our operating companies spend at least six months after approval of a new medicine educating health professionals before commencing a direct-to-consumer advertising campaign," wrote William C. Weldon, chairman and CEO of Johnson & Johnson. 

Dingell and Stupak said they were pleased by the drug companies' response, but that they still wanted a two-year limit. Stupak stated: "Although we appreciate the drug companies' willingness to change some of their business practices, they have not agreed to all of our requests, which would protect consumers from misleading and deceptive advertising. We accept PhRMA's offer to discuss these issues seriously. We hope the discussions with PhRMA will result in an industry position that addresses the concerns that Pfizer, Merck, Schering-Plough, and Johnson & Johnson continue to ignore." 

Ken Begasse, Concentric Pharma Advertising			

The moratorium was an outgrowth of a hearing on May 8 before the House Energy and Commerce committee. Entitled "Direct to Consumer Advertising: Marketing, Education, or Deception?" the hearing centered on broadcast ads for three high-profile drugs: Pfizer's Lipitor, featuring Dr. Robert Jarvik; Merck/Schering-Plough's "food & family" ads for Vytorin; and Johnson&Johnson's ads for Procrit. The committee heard testimony from consumers on how they perceive DTC advertisements, and also from pharmaceutical companies who defended their marketing practices. 

There was an encore quality to this summer's talk about banning drug ads. It came almost exactly a year after the ad and pharmaceutical industries defeated a similar initiative in 2007. Nonetheless, what emerged—the six-month moratorium—is new.  

So what does it mean? Is it no big deal, a bone thrown to Congress to appease them? Or is it the first step down a slippery slope—one that will lead to drug companies agreeing next to a two-year ban, followed by a multiyear moratorium, followed by ... 

Will Congressional scrutiny along with self-regulation affect the quality of the ads? Some (the new Lipitor ad in particular) appear to already have lost their "oomph." And consumers are finding the current crop of DTC ads unmemorable, according to a Nielsen IAG report. A large number of viewers are tuning out the ads altogether. CNW marketing research reports 32 percent of all drug ads on TV are ignored, and 45 percent of these ads are skipped by using devices such as TiVo. And who knows what additional pressures a new (perhaps Democratic) administration will bring?  

In the past few years, the industry has been putting more and more focus on direct-to-consumer marketing. In 2007, pharma shelled out $5.4 billion on DTC advertising, according to Nielsen Monitor-Plus; more than half was spent on television. Will the moratorium impact that volume? And what will it mean, if anything, for the industry? Is it time to bring the focus back to marketing to the physician? For answers to these questions and others, we asked the heads of some top pharmaceutical advertising agencies for their insights, opinions, and reactions. The following executives have two things in common: All run independent agencies. All are very much their own person. 

Chicago's AbelsonTaylor has a reputation for turning out highly creative direct-to-consumer advertising. Dale Taylor, the agency's CEO, isn't the least bit concerned about the moratorium. On the contrary, he believes it could have a beneficial effect.  

"It has always been appropriate to build healthcare professionals' confidence in the safety and efficacy of a new drug before promoting it through DTC," he says. "Doctors can, and do, say no to patients, especially when other alternatives are available." 

"Pharmaceutical marketing is more than promotion," says Taylor. "It's about doing all the things that need to be done to provide useful medications, and doing them in the right order. The right order is: doctors first."  

As for self-regulation putting a crimp on creativity, Taylor is not worried about that either. "What dampens creativity is the preconception that work which strays from the 'formula' is risky, when the biggest risk is looking and sounding formulaic." 

Taylor believes the moratorium could have a positive effect. "It should enhance our ability to create messages that are consonant with the physician's experienced understanding of the drug. When we make those messages perfectly consonant, our chances of the patient getting a 'yes' when she raises her hand and asks for help go way way up." 

Nancy Beesley, HC&B Healthcare Communications' EVP, concurs. "As much as we'd like to get our information into the hands of patients sooner, we need to do a better job of educating our doctors first so we don't risk frustrating them." 

Still, she worries about the consequences of holding back information: "If you're launching a novel cancer drug, shouldn't patients have a right to know?" she asks. "We keep making more rules, when the issue is really about access to information. If more companies accept the moratorium, then it's only fair the FDA should give a little and allow manufacturers some flexibility around the 'new' policy. Pharma manufacturers should give, but so should the FDA, so everyone can compete fairly in this environment."  

As for Web sites: "They still should be in play, but keep them unbranded and focused on the disease. Make sure the content is more objective and not skewed only to your therapy," says Beesley. "That's what consumers want anyway—real information they can use to evaluate products and treatments for themselves." 

But why not branded Web sites (studies have shown they are the most successful form of online marketing)? Does the moratorium include them? Are they even considered advertising?  

"We have never been able to get unambiguous guidance from the DDMAC [FDA's Division of Drug Marketing, Advertising, and Communications] whether a Web site is labeling or advertising," says Bill Drummy, CEO of Heartbeat Digital. "And believe me, we have asked. In our view, the pieces of the DDMAC acronym that really apply to Web sites are definitely the C and possibly the M: A Web site is certainly a form of communication, and partially a form of marketing; but it is not, essentially, advertising." 

				"The consensus among our clients is that a branded Web site is not subject to the same restrictions as TV or print ads." 			

Further, Drummy feels strongly that pharma companies have an obligation to provide complete information about their products as soon as they become available for sale. 

"In fact, if pharma companies didn't typically provide comprehensive product information online, we might find legislators requiring them to do so. Physicians want to understand the MOA, safety, and administration requirements; patients want to know what the medicine is, how it works, what the side effects could be, and how to talk to their doctors about it. So a branded Web site needs to answer all these questions and should do so right away." 

On the other hand, Ken Begasse, COO of Concentric Pharma Advertising, thinks the adoption of a six-month moratorium serves the public well. "It provides adequate time to educate healthcare practitioners on new products for medical conditions and determine any adverse events without delaying public awareness of potentially lifesaving treatments," he says. 

"At the moment, the industry has no clear guidelines about what is acceptable in DTC advertising; acceptability is open to interpretation—by DDMAC and by marketers themselves," says Begasse. "So while marketers are developing and producing ads they believe to be appropriate and acceptable, it's only after they are seen that they may be deemed to be in violation. As a result, many companies are second-guessing themselves and opting to produce only the most conservative ads, which often lack appeal. " 

				"While movements to ban 'reminder' advertising and the standardization of DTC communication guidelines have certainly increased advertising's ability to educate consumers, they have also, unfortunately, decreased creativity." 			

At MicroMass Communications, president Jay Bigelow takes a more sanguine view. "Is a voluntary moratorium appropriate?" he asks. "Probably. In the current court of public opinion, pharma manufacturers are often seen as somehow nefarious and manipulative. Anything individual companies or the industry can do to dispel that misperception is a good thing. Of course, an even better course would be to change the conversation altogether. Make it about the positive benefits of today's pharmaceuticals. Make it about the need to empower patients to take a more active role in their healthcare." 

As for the quality of the ads, Bigelow feels equally optimistic: "Will a moratorium hamper creativity? Not at all. While a regulated industry always operates under heavier constraints than an unregulated one, great creative, based on sound insights, can always find a way to hit home." 

Between Congress, the courts, and consumers, DTC is having a rough year. Pharma marketers are now being pressured to delay direct-to-consumer advertising for six months. Is it time to pay more attention to educating doctors and patients?

Branding Under Fire

Consumers have joined the courts and Congress this year in giving thumbs-down to DTC advertising. Not only are viewers finding the ads less memorable, many have stopped watching altogether. Thirty-two percent of all drug ads are actively ignored on TV, while 45 percent of ads are skipped using personal video recorders, such as TiVo, according to CNW Marketing Research.

What is a brand team to do? Well, if consumers are ignoring the commercials for the shows, why not put the commercials in the shows?  

The integration of pharmaceutical brands into the story lines of entertainment shows may be a new evolution in the industry's focus on DTC advertising, say two UCLA medical school researchers in the paper, "Pharmaceutical Product Placement: Simply Script or Prescription for Trouble?" published last May in 

The Journal of Public Policy and Marketing 

(see "Detailing Dr. House: Promotion or Risky Prescribing?"). In 2006, they counted 462 mentions of prescription meds on TV shows. This, according to Nielsen Product Placement, is double the figure from the year before.

Product placement advertising (also called stealth or subliminal advertising) is the insertion of a product or service into a script or scene of a TV show or movie, usually for a price negotiated with the network, producer, or scriptwriter. It has proven to be a highly effective method of marketing for a host of different products, from food to computers to cars. The overall market for product placement rose 3.5 percent to $3 billion in 2004, according to the paper's authors, professor Dominick Frosch and research assistant Sony Ta.

While controversy exists over how effective and ethical product placement is, most agree that as a marketing tool it has two big things going for it—it is relatively inexpensive, and is as-yet unregulated.

Pharmaceutical companies seem to have been slow to adopt product placement as part of their marketing mix. No pharma company has admitted having anything to do with the surge of drug mentions on TV shows. And only one company, Organon Pharmaceuticals, has openly embraced product placement. (To promote their NuvaRing contraceptive, they paid to have a poster appear in the examining room on the sitcom 

Why the reluctance? Frosch believes it could be due to the conservative nature of drug companies, and perhaps a concern about trivializing medicines and illness by associating them with entertainment. Or maybe, at a time when DTC is being so closely scrutinized, companies would just as soon keep whatever product placement marketing they're engaged in as quiet as possible.

Nonetheless, Frosch says the potential for pharma product-placement marketing remains, and the inclusion of drug names in scripts is, at present, poorly supervised. Drugs are a different kind of product, says Frosch, and promoting them through product placements requires new FDA guidelines.

To find out more about his views, we interviewed Dr. Frosch by phone:

If pharma denies involvement in the frequent drug mentions on TV, why should we be concerned? 

Whether or not the drug mentions are deliberate and effective is very difficult, if not impossible, to determine without inside knowledge. But clearly there have been some documented placements that we note in our paper. Zoloft in (the 1999 movie) 

 and we had a suspicion about the use of Lupron in the episode of (the Fox drama) 

. (This claim was denied by the show's medical adviser—see "Detailing Dr. House: Promotion or Risky Prescribing?").

Would you explain why product placement is so powerful as a marketing tool? 

When you're watching a television program and the commercial break comes on, you know what you're seeing is an advertisement. I think a light goes on in people's heads that says, "I'm being promoted to." But when a brand is integrated into a storyline, and it's not perceived as an advertisement, it legitimizes the use of the product in a very different way.

What do you perceive are the dangers to the consumer, if any, of this kind of product placement marketing? 

Prescription drugs are a different class of product. Oftentimes, they have risks that are inherent to using them even if you use them according to directions. For consumers to make informed decisions, they need to be able to understand the potential benefits and risks of the product. The point of our paper is to say that there's a regulatory void here, and there's a potential for misuse or for consumers to be misled about products.

You call for regulations. Who would establish the guidelines? 

It seems to fall between agencies. The FDA and the FCC have different views on how to define this. The FDA does not clearly define even what constitutes an advertisement. So that would need to be clarified. The FCC, on the other hand, might state the need for a sponsorship list in the credits. The other sort of alternative would be to recognize these as drug placements. That is, if you can figure out a way to identify them as advertisements, and then require them to follow the same guidelines as typical prescription drug ads.

Do you think there's a difference between calling a drug by its brand name and calling a drug by its generic name? 

Our sense was: If there was a case where [a drug mention] was a product placement, it more likely would be the one described by the commercial name, not by the generic name. But then, these are medical shows so it's perfectly legitimate for there to be talk of products. The difference is when someone has been paid to use a particular product.

In other words, just saying the name of a drug doesn't make it an advertisement?  

Drugs are being mentioned more and more on TV shows. Is it just part of the script-or promotion on the part of the industry? If so, should it be regulated?

Pharmaceutical Product Placements: The Next DTC?

A superstar baseball player is rushed to the hospital with a broken arm. Tests show the athlete is also suffering from numerous other symptoms, including kidney failure, liver damage, hallucinations, and hypogonadism.

Enter Gregory House, the misanthropic, diagnostic genius and protagonist of 

 the hit TV medical drama. In House's cynical worldview everyone lies. And so when the baseball player says he's never used steroids, House doesn't believe him and treats his hypogonadism with Lupron.

Even for House, who is renowned for prescribing drugs that will as easily kill the patient as save him, this treatment choice seems puzzling.

"Ludicrous," wrote Scott Morrison in his blog "Polite Dissent" the morning after the show aired. Morrison, a doctor, TV critic, and avid 

-watcher, parses and rates every episode. He gave this particular show a D for the medicine. "Admittedly, this area of medicine isn't my specialty, but this makes no sense. Lupron suppresses the production of sex hormones, something the patient is already low on. He is causing hypogonadism in a patient who already has that problem."

Dr. House (played by Hugh Laurie) in search of a diagnosis			

Dr. House's Lupron treatment also raised the eyebrows of Dominick Frosch and Sony Ta, UCLA medical researchers and authors of "Pharmaceutical Product Placement: Simply Script or Prescription for Trouble?" published last May in the 

Frosch and Ta found the use of Lupron (leuprolide, from Abbott) and the four mentions of the drug on the show "suspicious," and wondered if they weren't a paid product placement (also called stealth or subliminal advertising)—the insertion of a product or service into a script or scene of a TV show, usually for a price negotiated with the network, producer, or scriptwriter.

"The doctors were using the product to treat hypogonadism, which is not a FDA-approved indication for this medicine," wrote Frosch. "Indeed, Lupron is traditionally used to suppress testosterone production as a treatment for prostate cancer." Further, they noted "a newer pulse-dose Lupron is currently being evaluated as a treatment for hypogonadism in a FDA-registered clinical trial. The off-label use of this product in this show and the concurrent FDA trial appear more than coincidental."

House (played by British actor Hugh Laurie) bears more than a little resemblance to Sherlock Holmes. Both are unconventional, both are drug addicts (Holmes to cocaine, House to Vicodin), and both are driven by unconventional means to solve cases: For Holmes, it's about catching a criminal; for House, it's about diagnosing a disease.

Each episode of House follows basically the same pattern: A patient is rushed to the hospital; House takes on the case; his team misdiagnoses the disease; the patient almost dies; a light bulb goes off in House's mind; he figures out the problem and the patient lives (usually). The disease is almost always arcane. In the case of the baseball player, it turns out to be colchicine poisoning. (Don't ask.)

The character of House, with his risky, high-prescribing habits, makes the show fertile ground for all kinds of drug mentions—more so perhaps than any other medical TV show. Overall, drug mentions have doubled on TV in the last two years, according to Nielsen Product Placement.

 a product placement for promotional purposes?

"Absolutely not," says Harley Liker, medical adviser to 

. The show, he says, which attracts 20 million viewers weekly, contains no paid pharmaceutical product placements.

"Zero, zero, none," says Liker. "I talked about this with the writers. Their reaction was that it was almost the opposite: They try to avoid mentioning specific brand names whenever possible, partly because of potential legal issues."

Liker, who holds both medical and business degrees and serves on a global advisory board for AstraZeneca, functions as a consultant on 

. "I'm not on the set every day. I get a script, or I talk about an idea with someone. I make sure that the vernacular is appropriate and that the story line makes sense."

Lupron was not his idea. "It was not my detailing," says Liker. "Many people come up with ideas, including a doctor who is a full-time writer on the show."

Liker attributes House's off-label use of Lupron on the show more to House's character than the drug.

"House is very untraditional. He is a risk-taker, constantly thinking outside the box. He is actually more likely to use a drug off label than he is on-label. It has more to do with who Doctor House is and the way he approaches medicine."

As for the apparent knowledge of Lupron's off-label indication, the clinical trials, and the testing of Lupron for hypogonadism for FDA approval, Liker credits the writers who, he says, are very aware of what is going on in the medical world. "When we're doing cutting-edge stuff, we'll say, 'We're going to try this new drug that's been developed.'" Liker, however, stresses that it's the disease and not the drug that determines what drugs are mentioned.

"We think about how we are going to treat the disease, or condition, or symptom, not the other way around. It's not 'OK, how can we highlight Drug A, B, or C.' It's never part of the discussion. Never.

"We basically start with the diagnosis that we're going to be exploring, and work our way backwards. It's not like, 'Oh, well, let's go down this path and this is where we're going to end up.' It's actually, 'Here's where we're going to end up with this weird diagnosis of, say, neurocystercercosis?' And 'OK, well, how many things look like neurocystercercosis that we can try and masquerade as potential diagnoses before getting to neurocystercercosis.' We don't want to get to the final diagnosis until the final act, right? Otherwise you give it away," says Liker.

"For example, let's say someone had a tumor in their lung, and they presented with chest pain. Well, if they came in to the Emergency Room and they were having chest pain, we would give them nitroglycerin because that's what you do. So the thinking is never, 'Oh, we need to incorporate nitroglycerin into the story.' One of the diseases that can often masquerade as other diseases are autoimmune processes. So if you look at 

Dr. House, the lead character in TV's hit medical drama, House, is a high-prescribing diagnostician whose drug treatments can as easily kill or cure a patient. Can this be marketing?

Pharmaceutical Executive-10-03-2008