Select Committee on Health Written Evidence


APPENDIX 33 (PI 125)

Memorandum by the University of Stirling

Dealing in Drugs: An Analysis of the Pharmaceutical Industry's Marketing Documents

1.  INTRODUCTION

  As part of their investigation into the conduct of the UK pharmaceutical industry, the House of Commons Health Select Committee obtained access to internal documents from various pharmaceutical companies relating to their marketing activity for specified products or programmes. The Institute for Social Marketing (ISM), at the University of Stirling and the Open University, was asked to analyse these documents and prepare a report.

  The committee obtained documents from five pharmaceutical companies: GlaxoSmithKline, AstraZeneca, Pfizer, Eli Lilly and Wyeth. Each company was instructed to provide all promotional and product support material for specific brands or programmes (see Table 1 below). On the ISM's advice, the Committee requested a range of documents, including: contact reports between clients and agency/agencies, client briefs, creative briefs, media briefs, market research reports, details of public relations activity and any other documents relating to promotion and product support. A total of 49 boxes were obtained.

Table 1

SUMMARY OF DOCUMENTS OBTAINED


CompanyProduct/Brand

GlaxoSmithKlineSeretide
AstraZenecaNexuim
Crestor
PfizerCelebrex
Bextra
Liptor
Eli LillyZyprexa (Well being support programme) Cialis
(36 hours of freedom)
WyethZoton FasTab


  The Association of the British Pharmaceutical Industry (ABPI) Code of Practice, 2003, covers all forms of promotional activity by the UK pharmaceutical industry. Although the code itself is self-regulatory, it was designed to reflect the requirements of the Medicines Act and the European Advertising Directives, which are legally binding. The Code states that promotional activity by the pharmaceutical industry for prescription-only (PO) medicines should only target members of the health professions and not the general public, and in doing so should abide by the code in "both spirit and letter" and such promotion should be carried out "in a responsible, ethical and professional manner". The documents obtained were analysed around four key themes taken from the Code of Practice.

    —  Targeting patients and general public.

    —  Servicing the emotional needs of health professionals and the use of branding.

    —  The use of public relations and building relationships to counteract negative publicity.

    —  Disguised marketing to the health professionals.

  In each area, examples were found that contravened the spirit if not the letter of the Code of Practice. This is of particular concern because the analysis is based on a small number of documents as three of the five companies provided a very limited set of papers. For this reason the results have been anonymised.

2.  FINDINGS

2.1  Targeting Patients and General Public

  The Code of Practice states that as far as targeting patients and the general public is concerned:

    "Medicines must not be advertised to the general public if they are prescription only medicines."

    Code of Practice, Clause 20.1

    "Statements must not be made for the purpose of encouraging members of the general public to ask their doctors to prescribe a specific medicine."

    Code of Practice, Clause 20.2

    "A company may conduct a disease awareness or public health campaign provided that the purpose is to encourage members of the public to seek treatment for their symptoms while in no way promoting the use of a specific medicine."

    Code of Practice, Clause 20.2

      Thus, beyond the simple provision of information, the pharmaceutical industry is prohibited from targeting patients and the general public with marketing and promotional activity relating to prescription-only (PO) medicines. In many of the documents, however, patients and the general public emerge as key targets for direct and indirect communications that go beyond the simple provision of information. Detailed and continuous market research, for example, is conducted with the public to uncover their emotional drivers and motivations, which are then exploited to encourage presentation to the medical services. Public relations activity is also used to encourage media coverage with the clear intention of targeting patients, patient groups and the general public. This activity is then tied into specific brands and their performance in the market place.

Market Research

  There is clear evidence that the industry is concerned with identifying populations who are not currently presenting to the medical services for diagnosis and prescription of medicines. This population, dubbed "the missing millions", are estimated to include almost 2 million people in the UK:

    "Through their strategic planning process, Company X have identified a population of patients . . . that do not currently present to their GP or take prescription medications." . . ."This population provides a significant opportunity for Company X."

  Research is then conducted with the aim of understanding what barriers exist to prevent these people from presenting and to identify factors, both rational and emotional, that will overcome these barriers and encourage presentation:

    "Overall aim:

    To understand how to target these patients and overcome their barriers to presentation.

    Specific aims:

    To understand the segments of patients that do not currently present to GPs

    To explore their rationale/belief systems that inhibit them from presenting

    Identify hooks and drivers to encourage them to seek advice

    —both emotional and rational."

      The documents make it clear that the pharmaceutical industry is concerned with using the results of such research to design strategies that are able to `target these customers' and goes as far as identifying which of these customers will be most `receptive' to their communications:

    "Evaluate and communicate channels that could be used to target these customers. Identify which segments are likely to be most receptive."

  This demonstrates that the pharmaceutical industry are concerned with targeting members of the general public, particularly those who are most likely to respond to their messages—and the fact that they refer to them as customers suggests that this is not just motivated by an interest in public health.

  The documents also demonstrate that the pharmaceutical industry employs sophisticated marketing principles, such as segmentation, targeting channel choice and source effects to maximise their success.

  Thus, their research is used to segment the population into smaller, more homogenous groups, and targeting strategies are employed to meet the specific and unique needs of each group. In one research paper, for example, segmentation principles are employed to identify various patient types based on their involvement with the condition and the impact their condition has on their life, including segments called "endurers", "sceptics" and "deniers". Figure 1 overleaf outlines all the segments identified.



[112]  The research then goes on to identify the most appropriate ways in which to target these groups to encourage them to present to the medical services. Figure 2 below outlines how they propose to target one group: "hard working heroes". This highlights that the main barrier to presentation for this group is a lack of perceived time and the research then suggests providing information on "how little time improvement requires" and suggests providing the incentive of prolonging their "working career" by taking medication.



  The research also profiles all of the identified patient groups according to ease of targeting (see Figure 3 overleaf). The majority of the "missing millions" are identified as "easier targets" in terms of their "willingness to take medication", although it is recognised that even this group "may still have reservations re prescribed `symptom relief' that needs to be taken continuously". "Prescribed symptom relief" can only be interpreted as prescription medicines.


  Given these reservations, a clear need is identified to "reframe perspectives" and "raise expectations re normality" among these "missing millions" and the documents highlight that "patients will need to be provided with hooks to make them `open to change beliefs'" and once belief patterns are changed, behaviour should follow suit". Again this must refer to their willingness to take medication, and a desire to make them more favourably inclined to do so.

  Research is also conducted with the general public which aims to "evaluate and communicate channels that could be used to target customers" and highlights more general communication principles the industry consider when targeting such general public groups. For example, the outcomes of the research suggest that the perceived source of the message is vital to the target audience's receptiveness to the communication.

    "Strong perception exists amongst missing millions that any communication or information provided needs to be from credible source, eg. GP, `medical organisation', patient group—NOT outwardly a drug company—stigma attached to pharmaceutical companies that they'd just be doing it to sell drugs', not seen to be patient focussed."

  Similarly, other more "credible" channels of communication are outlined:

    "Patient leaflets left on the counter in pharmacies/GPs surgeries—perceived to be more `credible' source than, eg at end of supermarket aisle."

Advertising and Public Relations

  There are also occasions within the documents when overt references are made to "direct consumer advertising" and again there is a desire that this advertising should be "not obviously from a pharmaceutical company". Potential routes are outlined, including "PR activities" in the form of "articles in lay press", "TV documentaries" and "soap operas"—which being indirect and unattributed are potentially more powerful than conventional advertising.

  Furthermore, the campaign is clearly aimed at those who will be "most likely to take action" which suggests that the campaign is primarily concerned with those who are most likely to benefit the company rather than those who may arguably be more legitimate targets, but more resistant to change. In a similar vein, concerns are raised in the conclusions and recommendations that some of the target audience are presenting to pharmacies rather than GPs or hospitals which "results in fewer scripts". This is clearly viewed as a threat and is described as "something to be monitored". More specifically, calculations are made regarding the number of people who are prescribed the company's brand. The clear aim of the campaign is to "be effective in attracting these people" which again makes it clear that the ultimate aim of the campaign is to increase sales of the company's brand.

  Public relations activity is also used to target "patients", "patient groups", "consumers" and "consumer journalists".

    "Increased understanding of the need to approach GPs."

    "To secure publication of three articles within the consumer media by end of March 2005."

  This PR activity aims, among other things, to promote awareness of specific diseases, the need to seek treatment and the benefits of specific brands.

    "Create a positive media and press environment for brand X. ` `Positive articles on brand X generating a positive press environment."

    "Generate a positive risk: benefit of brand X."

    "Strengthen relationships with target journalists to ensure brand X possesses a greater share of voice in the future."

    "Utilisation of real-life data to demonstrate the critical role of brand X".

  The documents also provide examples of research being conducted with members of the general public to evaluate the effectiveness of an "advertising campaign run in the national press". Although the Code of Practice allows pharmaceutical companies to run "disease awareness or public health campaigns", these are only permitted if the goal is to "encourage members of the public to seek treatment for their symptoms while in no way promoting the use of a specific medicine". However, the documents show that such campaigns are evaluated according to the impact on "future behaviour, information sought and treatments received" and there is a clear desire from the company who ran the advertising campaign to "provide a return on investment calculation", rather than evaluate it in terms of changes in the target audience's general knowledge, attitudes and behaviours concerning a specific condition.

  In summary, this section shows that the public are the target for sophisticated promotional activity by pharmaceutical companies; that this activity exploits emotional drivers and marketing principles that go way beyond the simple provision of information and that its ultimate effectiveness is directly tied in to specific brands. In our view this breaches both the letter and the spirit of the code.

2.2  Servicing the Emotional Needs of Health Professionals and the Use of Branding

  The Code of Practice states:

    "Information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all the evidence and reflect that evidence clearly."

    Code of Practice, Clause 7.2

      An important theme to emerge from many of the documents was the importance not only of creating products, but the creation of strong and powerful brands. An extract from one document describes brands as "existing only in the mind of consumers" and as something that the pharmaceutical industry "manipulate[d]".



"What is a brand?

Product
What is stripped of all its
emotional baggage
Constructed by manufacturing
Brand
What it becomes with all its
emotional baggage intact

Exits only in the mind of consumers—
understood, measured and manipulated by us."


  Figure 4 overleaf outlines the equal importance attached by the pharmaceutical industry to the role of "rational" and "emotional" elements in the development of strong brands. For example, emotional elements such as "how does using the brand make the customer feel?" and "how would others view users of the brand?" appear to be given as much importance as "what are the physical features of the product?" and "how do the features benefit the customer?".


This role of "emotion" is recognised as growing in importance given that there are "less clear rational differences" between different products within the pharmaceutical industry and therefore in order to "find further competitive advantage" products must be "differentiate [ed] on an emotional basis as well". One-document estimates that this can lead to a "50% increase in sales".

  Consistently throughout the documents, brands are deliberately associated with attributes that can not be described as "objective" as required by the Code of Practice, such as "energetic", "passionate", "desirable", "sexy", "romantic", "intimate" "relaxed", "effortless", "freedom" and "fun".

  Not only are brands deliberately associated with such attributes and designed and marketed to satisfy emotional as well as rational benefits, but there is a clear desire by the industry to exploit health professional's emotional needs and vulnerabilities. For example, the pressure GPs are under when prescribing and the difficulties they face on a daily basis including the pressure associated with prescribing the right medication, perceived difficulties in patient compliance and the risk of being judged by peers.

  Brands and marketing activity are designed accordingly to tap into "customer insight of hassle of how difficult the patients will be to treat", "likelihood of compliance" and to tap into their "emotional button of risk". Another document demonstrates that campaigns are deliberately designed to "give the perception that brand X is a trusted brand" and to "give the customer the confidence to prescribe Brand X first line for new patients". Similarly, marketing activity is designed to make GPs feel "unburdened, confident, no more heart sink moments, rebelling and responsible" by prescribing certain brands and to "provide reassurance that a large proportion of doctors are using brand X" and as a "decision beyond criticism".

  The documents go into detail about how best to communicate these messages, including the desired "tone of voice". For example, one document describes it as "important to convey confidence, reassurance" through the "tone of voice" of the communication. Figure 5 below outlines diagrammatically how one company identified the "need" of prescribers and devised strategies such as "differentiate brand X" through the use of slogans in order to provide prescribers with the "confidence" to prescribe their brand and to "commit customer[s] to increase brand X prescribing from current level".


  In our view all this is far from the "accurate, balanced, fair, objective and unambiguous" communication required by clause 7.2.

2.3  The Use of Public Relations and Building Relationships to Counteract Negative Publicity

  On public relations activity and the payment of honoraria, the Code of Practice states:

    "Companies are responsible for information about their products which is issued by their public relations agencies."

    Code of Practice, Clause 20.5

    "The payment of reasonable honoraria and reimbursement of out of pocket expenses, including travel, for speakers, is permissible."

    Code of Practice, Clause 19.1

      It is clear from the documents that public relations activity forms a key and integral element of marketing activity within the pharmaceutical industry. It emerges as a popular method of communication to both patients and the general public (see Section 2.1) and to members of the health professions. PR activity appears to be particularly important and relevant for countering times of negative publicity, particularly when the safety of products is called into question.

      The pharmaceutical industry conduct "extensive media monitoring" to identify coverage of their brands and there are various examples within the documents of negative publicity concerning the safety of certain brands, for example "[Publication] calls for brand X ban". Strategies to deal with such publicity are devised, including proactive discussion and press releases: "discussion regarding proactive response", "developing proactive releases and rationale", and responding to unplanned coverage through planning exercises: "setting the Record Straight plan", "developing reactive statements based on Company X messages" and utilising media contacts to monitor coverage: "initiating an early warning system for the Lancet via media contacts".

      Building long-term, sustainable relationships with various stakeholders, including journalists, key opinion leaders (KOL) and well respected medics and academics emerges as pivotal in dealing with such negative publicity and when conducting PR activities generally. These relationships are developed to influence media coverage:

    "To build relationships with national journalists."

    "To build advocacy with consumer press to secure a greater share of voice."

  Specifically, these relationships are leveraged to have an impact on the coverage relating to certain brands:

    "Development of a group of KOLs who will be advocates for Brand X on varying levels through proactive and reactive media opportunities."

    "The media spokespeople will be advocates and prescribers of Brand X who will be involved in issues management and with whom all brand X data is shared."

  Another interesting finding to emerge from the documents is the payment of considerable "honorarium" for such stakeholders to attend meetings organised by the pharmaceutical companies. One document states "In terms of honorarium, I can confirm that we will pay you a total of £10,000 for four meetings plus travel expenses".

  In a similar vein, relationships were also used in order to "maximise sales of brand X in 2004". For example, one company sought to identify "the most critical people to influence" such as "policy making customers" in order to "persuade these customers to endorse brand X over other . . . brands". As emerged from Section 2.2, explicit attempts are made to understand the "emotive drivers of these policy making customers".

    "It has been identified that a better understanding of the rational and emotional drivers of these customers, their attitudes and priorities would enable Company X to develop a better approach and communication tools tailored to their specific needs."

Similar examples were found within a hospital context:

    "Drive hospital endorsement and usage of brand X."

    "The development of key advocates and speakers for brand X in order that this hospital support can be taken out to primary care."

  In our view this is again a long way from objective and balanced treatment of important issues such as safety required by the code. It is also extremely debatable that a fee of £10,000 can be described as a "reasonable honorarium".

2.4  Disguised Marketing

  The Code of Practice states that:

    "Certain types, styles and methods of promotion, even where they might be acceptable for the promotion of products other than medicines, are unacceptable. These include: "Teaser" advertising whereby promotional material is intended to "tease" the recipient by eliciting interest in something which will be following or will be available at a later date without providing any actual information about it."

    Code of Practice, Clause 9.1, 9.2

    "Promotional material and activities must not be disguised."

    Code of Practice, Clause 10.1

      An important, and worrying, theme to emerge from the documents is the desire of the pharmaceutical industry to strategically "create the need" among health professionals for new brands before their launch, while not being explicit about the nature of their communication.

      One company, for example, devised a six-staged mail-out over a two year period to health professionals for the launch of a new brand. The first two stages of the mail-out were solely designed to communicate that "patients are being targeted with [treatment] but not hitting required targets" and that "there is a need for a more effective [treatment]". The aim is to "establish current underachievement" and as a "call for new treatments". At no point in these two stages is the new brand mentioned or is product branding used, nor is the ultimate aim of the campaign—to "create the need" for the new brand—revealed. In short, the promotional aim is being disguised.

      Only after five months is the brand finally introduced in a further mail-out. At this point the purpose is to "establish brand X brand values at launch—efficacy, freedom" and to "reinforce brand X efficacy and safety". Added to this is the need to "encompass a certain degree of education feel" in the mail-out, while the brand image is designed to achieve "freedom and peace of mind for all (controlled power)".

    Figure 6: New brand mail-out strategy

PROPOSED TIMINGS


Date
Type
Look
Message

Month 1
Targeted
50% CV Brand
50% PFL
Patients are being treated with [treatment] but not hitting required targets
Month 2
Targeted
50% CV Brand
50% PFL
New study shows that in UK patients still not hitting target. There is a need for a more effective [treatment] to help get patients to target.
Month 5
Blanket
25% CV Brand
75% Brand X
Brand X is the most effective [treatment] for lowering [condition] to target. It has a safety profile to all other treatments
Months 5-14
Rep activated
100% Brand X
Brand X is the most effective [treatment] for lowering [condition] to target. It has a safety profile to all other treatments
Month 15
Targeted
100% Brand X
Brand X is a safe [treatment]
Patient volumes in the UK
Onwards
Targeted &
Rep activated
100% Brand X
Supporting campaign refinement and resulting data



RATIONAL FOR TIMINGS


Date
Rationale
Evidence Item
Access Item
(Management Toolkit)

Month 1
To establish current underachievement of treatment goals in condition
Copy of
[clinical paper]
To be advised
Month 2
To reinforce UK Study findings that calls for new treatments to address non titration of patients to guideline targets
PFL published November 2002)
Copy of article
To be advised
Month 5
To establish Brand X Brand values at launch
—Efficacy
—Freedom
Brand X Launch March 2003)
[clinical] Trial
To be advised
Month 5-14
To reinforce Brand X efficacy and safety message
[clinical paper]
(Pooled data 24-26
To be advised
Month 15
To reinforce Brand X is a safe [treatment] that is being prescribed widely
[Trial] Publication
To be advised



3.  SUMMARY

  Prescription-only medicines are promoted using a combination of advertising, public relations, promotional and scientific meetings, branding and the construction of long-term and mutually beneficial relationships with key stakeholders. This activity is guided by detailed market research along with careful segmentation and targeting.

  This analysis shows that, on occasions, this marketing transgresses the Association of the British Pharmaceutical Industry (ABPI) Code of Practice, 2003. Specifically, despite clear rules to the contrary, it is apparent that:

    —  The general public and patients are seen as key targets for marketing communication campaigns on prescription-only medicines, and clever use is made of such phenomena as channel and source effects and emotional drivers to maximise audience susceptibility. These campaigns are tied in to the performance of specific brands.

    —  Campaigns targeting health professionals use emotional drivers, irrational constructs and branding strategies that are very far removed from the codes requirement for communications to be "accurate, balanced, fair, objective and unambiguous".

    —  Public relations and paid "key opinion leaders" are used to counter bad publicity, especially about product safety. Again the treatment of these issues is frequently neither objective nor balanced.

    —  Brand marketing is disguised and the need for new brands is artificially created prior to launch.

  These findings are especially disappointing as the Code emphasises the need for companies to carry out their marketing "in a responsible, ethical and professional manner" that follows "both the spirit and letter" of the Code.

  At the same time, it is apparent that the code has to tackle some complex and ambiguous concepts. Words like "objective" and "balanced" sit uncomfortably with marketing efforts that are by definition partial and techniques like branding which play on patently subjective feelings and emotions.

  This suggests a need, not just for a fundamental reappraisal of current pharmaceutical marketing, but of the code itself.

Gerard Hastings, Elinor Devlin and Susan Anderson





112   Although all of the figures presented in this analysis have been taken from the pharmaceutical industry's own documents some have been adapted slightly to ensure the findings remain anonymous. Back


 
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