Early majority 34% Early adopters 13.5%

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1 Perspectives A ghost in the marketing machine? Martin Austin is Managing Director of TransformRx GmbH, which he formed in 2005 to provide business advice to clients regarding investment and business development, after 30 years in the pharmaceutical industry. He was previously a principal in Paul Capital Partners, a US based specialist in secondary private equity and alternative asset investments and before that, was Head of Business Development for the pharmaceuticals division at F. Hoffmann La Roche in Basel, Switzerland. The marketing of innovations presents challenges that are far greater than those of ordinary new product launches. Innovations are by their very nature groundbreaking and, as such go beyond the experience of the customer in the marketplace. In many markets, innovation is almost endemic, toys and confectionery are prime examples where novelties are a large part of the product offer. In more technical markets however, where safety is a major factor, such as automobiles or medicine, there are many obstacles to be overcome before a successful launch can be achieved and are of a different nature because of the very novelty of the innovation. The majority of the world s population typically displays an innate conservatism that in its extreme, can be highly reactionary. This is however counterbalanced by a sometimes reckless curiosity among a tiny group who will experiment and investigate novelty for its own sake. Between these two extremes, there is a range from bravery to timidity which has been described diagrammatically to show the frequency distribution of behaviours among a standard population in response to a new product. As Figure 1 demonstrates, there is a general bias toward caution. Recently, there has been renewed study of this phenomenon with a focus on the adoption of computers and Martin Austin Managing Director, TransformRx GmbH, Picassoplatz 8, Basel 4052 Switzerland Tel: mcaustin@bluewin.ch Innovators 2.5% Early adopters 13.5% Early majority 34% Late majority 34% Laggards 16% Figure 1: Diffusion of innovation curve (after Rogers, E. (1995) Diffusion of Innovation. The Free Press, New York.) # Palgrave Macmillan Ltd /06 $30.00 Vol. 6, Journal of Medical Marketing 57

2 Austin use of the internet, which because it is conducted on the internet, has had the benefit of a broad reach and rapid response to questionnaires. This has gone a long way to quantifying the diffusion phenomenon in large populations where previously research work was limited by older techniques which relied on smaller samples because of cost and organisational issues (Figure 1). In medicine, unlike consumer markets, the decision to test an innovation will not be taken by an individual to satisfy their own needs as with computer use, rather, decisions will be made on behalf of a patient whose comprehension of the risks and alternatives in the choice of the therapy may be quite limited. This adds a new dimension to the adoption of innovation. Although an innovator group does exist in medicine there are hurdles of a different magnitude and significance to initial usage as compared with consumer marketing. Moreover the problem that faces the marketer of innovative products in pharmaceuticals can be considerably more complex as a result of heightened media attention towards healthcare in general and pharmaceuticals in particular. These hazards can be further compounded by uncontrolled actions by some among the innovator group which, if they ignore the manufacturer s and regulator s recommendation, can be a major hindrance to the proper communication of information on a newly launched medicine. As a launch progresses it can be difficult for a company to ensure that the campaign stays on-message, if the product is being used incorrectly and results are widely published. In a number of notorious cases of newly launched pharmaceutical products, a few practitioners have prescribed products in unlicensed or experimental situations with disastrous results, despite the regulatory safeguards to prevent this happening. A product used in photodynamic therapy for cancer suffered this way when some investigators used a greater exposure time than recommended in the manufacturer s clinical protocol and published a warning that the product was dangerous. Several deaths occurred when severe allergic reactions followed intravenous injection of a new monoclonal antibody for rheumatoid arthritis (a large protein molecule), yet without providing a resuscitation trolley in the treatment suite as this had not been explicitly stated as a requirement on the prescribing information. Occasionally, such inappropriate use has blighted the reputation and adoption of products through lack of suitable cautionary advice from the marketing company. There have been several instances of products revealing serious side-effects soon after launch, such as Tysabri, or long after, such as with Vioxx and the atypical antipsychotic drugs which have recently been black-boxed and the media is often unable to discriminate between the sources of fault. These high profile product failures place an increased burden on the marketing of innovative products which require greater vigilance in the provision of correct information in the lead up and launch into the market. The risks of innovator induced failure compound the already difficult process of managing a successful pharmaceutical launch. Even in the absence of an underlying product risk, managing the introduction to innovators in such a way as to carefully control experimental use while still encouraging the fastest reasonable rate of adoption in the marketplace is the challenge. In this context, the word reasonable should of course take full account of the risks and benefits to patients of the medicine. Here the severity of the disease and the benefit of the product will have a great bearing on the strategy that can be adopted. The circumstances of a first in market, life-saving treatment in 58 Journal of Medical Marketing Vol. 6, # Palgrave Macmillan Ltd /06 $30.00

3 Perspectives cancer or heart disease will be hugely different to a novel therapeutic for a disease like skin dryness. While both may address novel therapeutic targets, tolerance of product risk will be dramatically different. Examples of this are currently to be seen in the actions of the FDA requiring warnings on immunosuppressant products for childhood eczema compared with the demands by many patients and physicians for continued availability for Tysabri for multiple sclerosis, despite the marketing companies withdrawal of the product in the light of patient deaths apparently related to its use. Despite impediments and hazards such as these, one of the greatest challenges to a successful launch is still the inertia of the 84 per cent of physicians who are neither innovators nor early adopters. The increasingly limited patent life that remains for a product after launch means that the adoption rate of the different classes of prescriber will determine its ultimate profitability. Rapidly gaining awareness is a key factor and if the prescribing group is large, as in primary care markets, then the logistics of contact are a considerable hurdle when compared with a narrowly based market such as neurology. Between these alternatives, there is a gradient of expenditure which represents increasing cost to the marketer. The slope of a graph of the cost-per-sale relationship will be almost linear until a tipping point is reached. This critical mass of users represents the point beyond which a whole market segment of physicians begins to prescribe the product for more of their patients, and to recommend it to colleagues. Exponential growth may then commence leading a snowball effect in the market, further accelerating use across segments and potentially creating blockbuster sales. In order to reduce the time and cost of this process, a communication strategy needs to be developed to address each of the diverse groups that make up the market. The single curve shown in Early majority Innovators Early adopters Figure 2: Multiple adoption curves by differing penetration rates # Palgrave Macmillan Ltd /06 $30.00 Vol. 6, Journal of Medical Marketing 59

4 Austin Figure 1 however does not adequately reflect this diversity and might be better thought of as a series of adoption curves, each one overlying the next and having different communication and strategic marketing needs. Certainly, the psychological characteristics of the physicians in the different groups will have their own dynamics and determine a threshold of comfort for each group to adopt the product. A prerequisite to adoption is often use and public recommendation by the members of the preceding group, before adoption later when physicians feel enough confidence in a new product to initiate its use among their own patients. These opinion leaders may be of international or local importance but are pivotal to dissemination of information about innovation (Figure 2). The influence of opinion leaders as a source of information compared with research publications is largely psychological in nature and this needs to be well understood by the marketing company. While the relationship between the technical complexity of products and the disease area has considerable sway among users, the choice of a product goes beyond the merely scientific explanation of how it works in comparison with others for a disease. This was shown in the 1980s through attitudinal research that was conducted with physicians in the UK among groups of differing experience and roles in medicine practice. The research was very revealing about the nature of the confidence expressed by hospital consultants and general practitioners, respectively about the value of technical product knowledge versus the relationship of the physician to the patient and his disease. As a part of the research programme, they were asked to describe the emotional landscape surrounding certain diseases when disassociated from technical explanations, which peeled back Figure 3: Hypertension, by a UK general practitioner the veneer of expertise exposing uncertainties and fears not usually apparent in medical marketing. The sessions were led by a clinical psychologist and the groups of doctors were taken through a series of exercises more typical of those used with maladjusted patients to reveal the drivers of their behaviour patterns (Figure 3). The model in the Figure 3 was created as a part of one of these exercises and depicts the embodiment of one general practitioner s feelings about hypertension. In his commentary that went along with the model, the crushing oppressive nature of the disease was explained. He went on to describe the insidious nature of hypertension and the helplessness that he felt in being able to do nothing more than treat the symptoms, while all the time the threat of heart disease lay behind and this theme was echoed by many in the sessions. In the face of challenges of this nature, education of a market in preparation for a launch into an unfamiliar disease is of paramount importance, particularly where no treatment has previously been available. This requires an in-depth understanding of 60 Journal of Medical Marketing Vol. 6, # Palgrave Macmillan Ltd /06 $30.00

5 Perspectives Innovators Opinion leaders Early followers Late followers Figure 4: The marketing cascade the drivers affecting current practice and the attitudes that will be engendered by a changing of the current status quo. Only when the psychological landscape of the new therapy has been mapped can a fully effective campaign be planned and a programme developed to address points of psychological resistance and so the diffusion process can be more effectively managed (Figure 4). In this context, the cascade approach to marketing of products can then be goal directed and fine-tuned to the different constituencies in the market and the adoption rate be kept in step with the concerns of the prescribers and yet in keeping with the scientific and regulatory framework within which the company must work. Qualitative market research has established over many years that the most important features of any new product will always be the safety and efficacy. This is both an intellectual and an emotional response by physicians addressing their own concerns as well as their duty of care for the patient. When these two factors are weighed against any others, such as price, or convenience, their significance is of a different order of magnitude dwarfing that of other ancillary features. Yet, depending on the circumstances of the prescribing decision, these two primary drivers can have different profiles. In hospitals, due to the nature and severity of patients disease the balance between safety and efficacy shifts more toward equality, as opposed to primary care, particularly when the disease is advanced, acute or traumatic. In primary care, where long-term therapy is more usual, disease symptoms are commonly less severe and so safety dominates efficacy. This permits comfort and convenience to become stronger supportive drivers of efficacy, with the intention that the patient will not be put-off complying with their therapy. The hierarchy of product features in the promotional message may then be established for the functional segments in the market. Dealing with these barriers require more from the marketer as latent psychological hurdles can easily translate into logistic barriers and generate costs and time pressures which could subvert the whole marketing plan. When considering a launch into such a new market therefore, the marketer needs to address concerns of a much deeper level than the merely technical. Physicians, as with other professionals, like to feel in control, and their decision to prescribe is an expression not only of their technical expertise but the affirmation of their role as the expert in diagnosis and treatment. The marketing communication can be enhanced by addressing these concerns. In order for a treatment decision to be made with confidence, preparative information provided by the marketer needs to address these underlying concerns regarding disease as well as therapeutic choice. This approach is best applied well before the introduction of an innovative new product and involves more time and cost than the launch of a substitute for an existing therapy but will have a strongly positive effect on sales and brand loyalty. To maximise the effectiveness of this approach, the environment of the launch can be mapped as a function of the # Palgrave Macmillan Ltd /06 $30.00 Vol. 6, Journal of Medical Marketing 61

6 Austin Product Disease Figure 5: Product/disease knowledge matrix relationship between knowledge of the disease (the patients, the doctors and their responses) and the knowledge of the products (Figure 5). Put diagrammatically, a product launch campaign which does not address both axes in the correct sequence will struggle to penetrate the market at the best rate. While this is in some ways obvious, there is still a continued reliance on a technical show-and-tell in many promotional campaigns, especially where previously unmet medical needs are being addressed with innovative products. The industry often displays a fascination with the technical solution for a technical defect and this can end up taking precedence over the primary focus of a doctor treating his patient. This overly mechanistic approach seems to persist in the marketing of medicines and this has perhaps been reinforced by the economic needs of the pharmaceutical industry, where innovation is the key to growth and patent life is short. Marketing by the numbers has been efficient from several points of view but perhaps risks missing the point that pharmaceutical products are only one part of the overall medical treatment. The relationship between physicians and patients can be reinforced by a rational and emotionally balanced prescription a relationship goes beyond the process of technical innovation. Attending more closely to these factors could also help win back a more positive relationship between physicians and the pharmaceutical industry and ease the introduction of innovative medicines. 62 Journal of Medical Marketing Vol. 6, # Palgrave Macmillan Ltd /06 $30.00