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					                                                                               07/165
                                                                          AWAP 07/006


                                      DECISION

                           Special Meeting 22 June 2007

                        Convened Pursuant to Rule 3 of the

          Constitution of the Advertising Standards Complaints Board



Complaint 07/165

AWAP 07/006


               Complainant: AstraZeneca Limited
               Advertisement: GlaxoSmithKline NZ Limited

Complaint: A series of advertisements, for Seretide asthma treatment, was
published in the February, March and April editions of the New Zealand Doctor
magazine, in a wrap around flyer attached to the March edition and in a brochure
published for public distribution.

The magazine advertisements stated inter alia:

“Seretide for total asthma control in one inhaler”

“Upgrade your patients to Seretide for TOTAL CONTROL”.

“Is your asthma goal total control? Consider Seretide.

Each of the magazine advertisements also contained the information that
Seretide is

“fully funded with special authority”, and lists the dosages that are fully funded

The Seretide guide for new users stated inter alia:

“Seretide can help you get back to being you”.
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“Used regularly Seretide may be able to help you feel free from the symptoms of
asthma and help you to do what you want to do”.


The wraparound flyer stated inter alia:

“Help your patients aim to live symptom free”

“Upgrade your asthma patients to Seretide for TOTAL CONTROL”

The advertisements referred to a study by Bateman et al published in the
American Journal of Respiratory and Critical Care Medicine. In addition the
advertisements in the March and April editions contained the following
clarification.

“The GOAL study examined whether guideline defined asthma control could be
achieved in 3416 patients with uncontrolled asthma. On Seretide 41% of patients
achieved total control and 71% achieved well controlled asthma for periods of 7 out
of 8 weeks after 12 months. Total control was defined as experiencing none of the 7
listed symptoms for at least 7 out of 8 weeks”


The Complainant AstraZeneca Limited said:

1.   AstraZeneca Ltd wishes to make a formal complaint about a number of
     advertisements for the "Seretide" asthma treatment, published and distributed
     on behalf of GlaxoSmithKline NZ Ltd.

     The advertisements

2.   The complaint relates to the following advertisements for Seretide, copies of
     which are attached:

     (a)   A full page advertisement published in New Zealand Doctor magazine on
           28 February 2007 (attachment A: first magazine advertisement);

     (b)   The Seretide guide for new users (attachment B: Seretide guide);

     (c)   A full page advertisement published in New Zealand Doctor magazine on
           28 March 2007 (attachment C: second magazine advertisement);

     (d)   A wrap around flyer distributed with New Zealand Doctor magazine on 28
           March 2007 (attachment D: wraparound flyer).

     (e)   A full page advertisement published in New Zealand Doctor magazine on
           11 April 2007 (attachment E: third magazine advertisement).

     First magazine advertisement

3.   The first magazine advertisement contains the following statements to which
     AstraZeneca objects:
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            Seretide for total asthma control in one inhaler

      and

            Upgrade your patients to Seretide for TOTAL CONTROL

4.    The first magazine advertisement also contains a statement that Seretide is
      "fully funded with special authority" and lists the doses for which Seretide is
      fully funded.

5.    The statements are referenced to a study by Bateman et al published in the
      American Journal of Respiratory and Critical Care Medicine (attachment F:
      Bateman study), sometimes referred to as the GOAL study.

      Seretide guide for new users

6.    The Seretide guide contains the following statements also referenced to the
      Bateman study:

            Seretide can help you get back to being you

      and

            Used regularly Seretide may be able to help you feel free from the symptoms of
            asthma and help you to do what you want to do

      Second magazine advertisement

7.    The second magazine advertisement contains the following statement also
      referenced to the Bateman study:

            Upgrade your asthma patients to Seretide for TOTAL CONTROL

8.    The second magazine advertisement also contains a statement that Seretide is
      "fully funded with special authority" and lists the doses for which Seretide is
      fully funded.

      Wraparound flyer

9.    The wraparound flyer contains the following statements also referenced to the
      Bateman study:

            Help your patients aim to live symptom free

      and

            Upgrade your asthma patients to Seretide for TOTAL CONTROL Third magazine
            advertisement

      Third magazine advertisement

10.   The third magazine advertisement contains the following statement also
      referenced to the Bateman study:
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            Is your asthma goal total control? Consider Seretide

11.   The third magazine advertisement also contains a statement that Seretide is
      "fully funded with special authority" and lists the doses for which Seretide is
      fully funded.

      Further statement

12.   The second and third magazine advertisements and the wraparound flyer
      contain the following statement in relation to the Bateman study (further
      statement):

            The GOAL study examined whether guideline defined asthma control
            could be achieved in 3416 patients with uncontrolled asthma. On
            Seretide 41% of patients achieved total control and 71% achieved well
            controlled asthma for periods of 7 out of 8 weeks after 12 months. Total
            control was defined as experiencing none of the 7 listed symptoms for
            at least 7 out of 8 weeks.

      Claims arising from the advertisements

13.   The advertisements claim/state and/or imply the following:

      (a)   Seretide is able to achieve total control of asthma;

      (b)   Seretide is able to achieve total control of asthma in all cases;

      (c)   Seretide is able to achieve total control of asthma at all doses; and

      (d)   Seretide is able to achieve total control of asthma with the doses for
            which Seretide is fully funded.

14.   On behalf of AstraZeneca, TNS has conducted a preliminary short survey of
      general practitioners in New Zealand to understand their perception of these
      advertisements and the claims set out above. Forty-four general practitioners
      were interviewed. This research showed1:

      (a)   39% of doctors surveyed were aware of the Bateman study.

      (b)   Only 11% of doctors surveyed indicated they had read a little of the
            Bateman study, while no doctors indicated that they had read all or most
            of the study.

      (c)   When given the claim "Upgrade your asthma patients to Seretide for total
            control", 75% expected that total control was achieved by the majority of
            patients in the supporting evidence.

      (d)   In addition, 57% of doctors said that the total control claim above was
            likely to increase their prescribing of Seretide.

      Claims are misleading and cannot be substantiated
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15.   Asthma is a variable disease and varies in severity. Treatment involves the use
      of inhaled medications to aim to prevent and relieve symptoms.

16.   Seretide is listed on the Pharmaceutical Schedule as a medication that requires
      Special Authority under the following criteria2:

      "Either:
      1      All of the following:
             1.1. Patient is a child under the age of 12; and
             1.2. All of the following:
                     Has, for 3 months or more, been treated with:
                     1.2.1 An inhaled long-acting beta adrenoceptor agonist; and
                     1.2.2 Inhaled corticosteroids at a dose of at least 400pg per day
                            beclomethasone or budesonide, or 200pg per day fluticasone; and
             1.3. The prescriber considers that the patient would receive additional clinical
                   benefit from switching to a combination product; or
      2      All of the following:
             1.1. Patient is over the age of 12; and
             1.2. All of the following:
                     Has, for 3 months or more, been treated with:
                     1.2.1 An inhaled long-acting beta adrenoceptor agonist; and
                     1.2.2 Inhaled corticosteroids at a dose of at least 800pg per day
                            beclomethasone or budesonide, or 500pg per day fluticasone; and
             1.3. The prescriber considers that the patient would receive additional clinical
                   benefit from switching to a combination product."

17.   The claims as set out in paragraph 13 are misleading and cannot be
      substantiated. "Total control" of asthma is a term based on commonly used
      guidelines for asthma treatment. It is used in the Bateman study as a
      composite measure to represent a total lack of any asthma symptoms.

18.   The results of the Bateman study were that:

      (a)   After Phase I `total control' was achieved in

            (i)    32% of patients with moderate asthma (stratum 2 patients); and

            (ii)   19% of patients with severe asthma (stratum 3 patients)

            treated with Seretide.

      (b)   After Phase II `total control' was achieved in

            (i)    44% of patients with moderate asthma (stratum 2 patients); and

            (ii)   29% of patients with severe asthma (stratum 3 patients)

            treated with Seretide.

      In both Phase I and Phase II of the study, physicians had the ability to escalate
      patients to the highest salmeterol/fluticasone 500/50 pg/dose treatment
      strength.
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19.   Under current reimbursement criteria, only patients with moderate or severe
      asthma are eligible for Seretide. Thus, patients in Stratum 1 of the Bateman
      study would not be eligible for reimbursement of Seretide in New Zealand.

20.   As described above, the majority of patients in the Bateman study with
      moderate and severe asthma did not achieve total control of their asthma. Only
      41% of patients overall, and only a minority in any stratum, were actually able
      to achieve total control (50% in Stratum1, 44% in Stratum 2 and 29% in
      Stratum 3) by the end of phase II. This is contrary to the claims that patients
      are able to achieve total control regardless of the severity of their asthma.

21.   Further, the Bateman study states that "most patients completed the trial on the
      highest dose of salmeterol/fluticasone". The percentage of patients on the
      highest dose of Seretide was 57% in stratum 1, 63% in stratum 2 and 85% in
      stratum 3. Therefore, the study suggests that the majority of patients who
      achieved total control were only able to do so using the highest dose of
      Seretide.

22.   The highest dose of Seretide used in the study was salmeterol/fluticasone
      50/500. This dose is not reimbursed in the New Zealand market. Indeed, the
      500/50 strength accounts for, at most, 2% of all Seretide units sold in New
      Zealand since reimbursement on 1 August 20063. Therefore, the claim that
      patients are able to achieve total control of asthma using subsidised doses of
      Seretide is misleading.

23.   As set out in paragraph 14, market research of general practitioners showed
      that the practitioner audience viewing these claims of total control are being
      misled. Seventy-five per cent of doctors expected that the supporting evidence
      would show that the majority of patients achieved total control. In addition, 57%
      of physicians indicated that the total control claim was likely to increase their
      prescribing of Seretide.

      Impact of further statement

24.   The misleading nature of the advertisements is not corrected by the addition of
      the further statement to the second/third magazine advertisements and the
      wraparound flyer as:

      (a)   The further statement does not state the dosage levels used to achieve
            the results;

      (b)   The further statement does not differentiate between the level of asthma
            severity of those who took part in the study and achieved the quoted
            results.

      (c)   Even if the qualifications required by points (a) and (b) above were made,
            the advertisements are exaggerated by implication by extrapolating
            results for a small minority of patients from a sub-set of the total trial
            population to make a generalised claim of total control.

      (d)   The further statement, even if further qualified by points (a) and (b), does
            not adequately qualify and/or make precise the central message of the
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            advertisements and flyer that Seretide, as funded in New Zealand,
            achieves "total control" of asthma.


      The breaches

25.   AstraZeneca believes that in the circumstances set out above:

      (a)   The advertisements are not truthful, balanced and are misleading in
            breach of Principles 2 and requirements B1 3, B1 4, B3 4 and B3 4.1(ii) of
            the Therapeutic Products Advertising Code (Code);

      (b)   The advertisements contain claims that are not valid and have not been
            substantiated in breach of Principle 2 and requirements B1 3, B3 3 and
            B3 4 of the Code;

      (c)   The advertisements claim or imply that Seretide is effective in all cases of
            a condition in breach of requirement B1 R 4.1(ii) and B3 R 4.1(ii);

      (d)   The advertisements do not observe a high standard of social
            responsibility in breach of Principle 3.

      Decisions of other therapeutic advertising regulators

26.   Complaints about similar claims in Seretide advertising have been upheld in
      the United Kingdom and Sweden. Copies of those decisions are attached
      (see G and H).

27.   There are court judgments in Australia that advertisements containing similar
      claims did not breach the Trade Practices Act. However, AstraZeneca
      considers that those findings are not relevant to the Board's consideration of
      this complaint because:

      (a)   the legal test applied by the Court is a distinct legal prohibition which is
            not germaine to determining whether the higher standards in the relevant
            Code have been breached;

      (b)   the highest dose of Seretide in the Bateman study is subsidised in the
            Australian market, (AstraZeneca notes also that the highest dose was
            also the most prescribed form in Australia as at September 2006).

      Correspondence with GlaxoSmithKline

28.   AstraZeneca raised these matters with GlaxoSmithKline in correspondence
      dated 22 March 2007. GlaxoSmithKline responded by letter dated 30 March
      2007, stating that they did not believe the advertisements breached the Code
      and would not take action over the advertisements. Copies of that
      correspondence are attached (see I and J).

      Conclusion
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29.   The magazine advertisements, wraparound flyer and Seretide patient guide
      contain claims that are exaggerated, misleading and unable to be
      substantiated. The majority of patients in the cited Bateman study did not
      achieve `total control' of their asthma. The majority of those who did achieve
      `total control' needed to be on a 50/500 dose of Seretide in order to do so. This
      dose is not reimbursed in the New Zealand market.

30.   In the light of the above, the magazine advertisements, wraparound flyer and
      Seretide patient guide are breaching the Code by claiming that Seretide is able
      to achieve total control of asthma at all, let alone in all cases and let alone by
      using dosage levels that are reimbursed in New Zealand.

Attachments:
A. Full page advertisement published in New Zealand Doctor magazine on 28
    February 2007
B. Seretide guide for new users
C. Full page advertisement published in New Zealand Doctor magazine on 28
    March 2007
D. Wrap around flyer distributed with New Zealand Doctor magazine on 28 March
    2007
E. Full page advertisement published in New Zealand Doctor magazine on 11 April
    2007
F. Bateman ED et al. Can guideline-defined asthma control be achieved? The
    Gaining Optimal Asthma Control study. Am J Respir Crit Care Med 2004; 170:
    836-844
G. Prescription Medicine Code of Practice Authority. Case AUTH/1635/9/04:
    Promotion of Seretide
H. Pharmaceutical Industry's Information Examiner, IGM. Case W653/04.
    AstraZeneca AB/ GlaxoSmithKline AB (GSK) regarding marketing of Seretide in
    advertising
I. Letter from AstraZeneca to GSK on matter of Seretide advertisements. 22 March
    2007
J. Letter from GSK to AstraZeneca on matter of Seretide advertisements. 30 March
    2007

References:
1. TNS. GP‟s perception of Bateman‟s GOAL Study. Market Research Report. April
    2007. Date on file
2. New Zealand Pharmaceutical Schedule. December 2006
3. IMS HI + PI February 2007


The Chairman ruled that the following provisions were relevant:

Code for Advertising Therapeutic Products:

      Principle 2: Advertisements must be truthful, balanced and not
      misleading. Claims must be valid and have been substantiated.

      Principle 3: Advertisements must observe a high standard of social
      responsibility.
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     Part B1 – Advertising Medicines to Consumers

     Requirement 3: To assist consumers to make informed decisions,
     advertisements must contain truthful and balanced representations and
     claims that are valid and have been substantiated.

     Requirement 4: Advertisements must not directly nor by implication,
     omission, ambiguity, exaggerated claim or comparison.

     Requirement 4.1: An advertisement must not: (ii) contain any claim,
     statement or implication that the product is effective in all cases of a condition.

     Part B3 – Advertising Directed to Healthcare Practitioners

     Requirement 3: Advertisements must contain truthful and balanced
     representations and claims that are valid and have been substantiated.

     Requirement 4: Advertisements must not directly nor by implication,
     omission, ambiguity or comparison mislead or deceive, or be likely to
     mislead or deceive.

     Claims and representations made in advertisements must be truthful and
     have been substantiated.

     Requirement 4.1 An advertisement must not: (ii): contain any claim,
     statement or implication that it is effective in all cases of a condition;

Procedure: The Acting Chairman ruled to deal with the matter by “adjudication with
attendance of the parties” pursuant to Rule 3 of the Complaints Procedures of the
Advertising Standards Complaints Board. This system was designed to resolve
disputes between competitors. Accordingly, the Acting Chairman appointed a Panel.

The Panel: Ms J. Courtney, Acting Chairman of the Complaints Board. Co-panelists
Mr M Turner, Alternate Member of the Advertising Standards Complaints Appeal
Board and Dr T Maling, an expert member of the Panel.

The Complainant, AstraZeneca Ltd, was represented by Mr L Gravatt, General
Manager and Ms J Gill, Associate Regulatory Affairs Manager.

The Advertiser, GlaxoSmithKline NZ Ltd, was represented by Dr A Hvizdos,
Medical Affairs Manager and Mr R Bycroft, Solicitor, Chapman Tripp.


Legal Counsel for the Advertiser, GlaxoSmithKline NZ Limited, said:

1    Thank you for your letter of 26 April 2007 inviting GlaxoSmithKline's (GSK's)
     response to AstraZeneca's complaint.
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     Summary
2    GSK rejects AstraZeneca's complaint. It is GSK's position that none of the
     advertisements complained about are misleading, and this is substantiated in
     this submission.

3    The central claim of the advertisements in NZ Doctor (Doctor Advertisements)
     is that Seretide can achieve total control of asthma. This claim is substantiated
     by the Bateman study and the Doctor Advertisements contain appropriate
     references to that study.

4    AstraZeneca seems to be arguing that GSK cannot claim that Seretide can
     achieve total control because it does not do so in every case. AstraZeneca
     seeks to justify its complaint on its own implied interpretation that no
     reasonable member of the public would take from the Doctor Advertisements,
     let alone the educated audience of doctors to whom the advertisements are
     addressed.

5    AstraZeneca's complaint is based upon its misrepresentation of the Bateman
     study results. AstraZeneca asserts that total control was only achieved at the
     highest doses of Seretide used in the study. That assertion is wrong.

6    AstraZeneca also wrongly attempts to link mandatory prescription medicine
     funding statements with therapeutic claims in the advertisements.

7    It is unclear from AstraZeneca's complaint exactly what its concerns are with
     the Seretide Guide. GSK is at a loss as to what the issues could be with the
     Seretide Guide as it contains none of the claims that, AstraZeneca complains
     of. The phrase "total control" is never used in the Seretide Guide.

     The Context of Asthma
8    Asthma is poorly controlled, and is not being effectively managed. It is a highly
     undermanaged chronic disease and a significant burden world wide. The
     Bateman study refers to over 95% of patients with asthma failing to achieve
     guideline-defined control of their asthma as the basis for wanting to enrol
     patients in this study. (Refer Appendix 1)

9    Asthma control in New Zealand is also poor. The POMS study concluded that
     there is a significant adverse health impact from asthma in New Zealand, which
     may be alleviated by the appropriate use of available medications. 1

10   The purpose of the Bateman study was to determine whether, despite these
     discouraging statistics, guideline-defined control of asthma could actually be
     accomplished. The Bateman study showed that such control can be achieved
     with Seretide.

11   As indicated in the title of the publication, the Gaining Optimal Asthma Control
     Study (GOAL or Bateman study) was conducted to answer the question "Can
     Guideline-defined Asthma Control Be Achieved?"

12   International asthma treatment guidelines have seized upon the Bateman study
     results and also promote a greater degree of asthma control as a realistic aim
     for doctors to treat their asthma patients.
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13   The Global Initiative for Asthma (GINA) was launched in 1993    .in
     collaboration with the National Heart, Lung, and Blood Institute, National
     Institutes of Health, USA, and the World Health Organization. GINA's
     programme is determined and its guidelines for asthma care are shaped by
     committees made up of leading asthma experts from around the world.

14   The GINA guidelines state, "There is now good evidence that the clinical
     manifestations of asthma - symptoms, sleep disturbances, limitations of daily
     activity, impairment of lung function, and use of rescue medications - can be
     controlled with appropriate treatment. When asthma is controlled, there should
     be no more than occasional recurrence of symptoms and severe exacerbations
     should be rare." (Ref: GINA. Global Strategy for Asthma Management and
     Prevention, 2006, p.2). (Refer Appendix 3)

15   The Bateman study demonstrated the ability of Seretide to reach this GINA
     goal in a clinically significant proportion of patients by aiming for total control.

16   GSK's Seretide advertisements not only seek to promote the prescription of
     Seretide, they also aim to educate doctors that total control of asthma is a
     realistic aim for their patients, In doing so, GSK is advertising responsibly to try
     and shift doctors' targets in an effort to improve the health of New Zealanders
     with asthma. That aim is consistent with the New Zealand Government's health
     strategy and international guidelines for the treatment of asthma.

     The Complaint
17   AstraZeneca alleges that GSK's advertisements state or Imply that:

     19.1 Seretide is able to achieve total control of asthma;

     19.2 Seretide is able to achieve total control of asthma in all cases;

     19.3 Seretide is able to achieve total control of asthma at all doses; and

     19.4 Seretide is able to achieve total control of asthma with the doses for
          which Seretide is fully funded, (paragraph 13, 13 April 2007 complaint
          letter)

18   AstraZeneca also goes so far as to suggest that GSK's advertisements are
     “breaching the Code by claiming that Seretide is able to achieve total control of
     asthma at all" (paragraph 30, 13 April 2007 complaint letter). This suggestion is
     totally inconsistent with the data presented in the Bateman study.

19   In fact, GSK's advertisements:

     19.1 do claim that total control is possible with Seretide. This claim is not
          misleading and it is effectively substantiated by the data in the Bateman
          study;

     19.2 do not claim that Seretide is able to achieve total control of asthma:

          in all cases,
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         at all doses, or

         with the doses for which Seretide is fully funded.

20   Doctors will be aware that no medicine will have the desired effect In all cases
     or at all doses. Every person is different, and not all medicines will work In the
     same way or to the same degree in all patients. All doctors know this as
     learned individuals in the field of medical science. AstraZeneca's suggestion
     that doctors would interpret the words "total control" to mean that Seretide will
     achieve total control of asthma in all cases, at all doses and with the doses for
     which it is fully funded discredits the intelligence of doctors and ignores the
     other trusted information sources that doctors routinely utilise to make informed
     medical decisions.

     The Context of Pharmaceutical Advertisements
     The Audience
21   The Authority sensibly assesses advertisements in the context of the likely
     audience. On its website the Authority states:

          "The conformity of any advertisement with the Codes will be judged
          primarily in terms of its impact upon the type of person who is likely to be
          exposed to it." (http://www.asa.co.nz/interpretation.php)

     In the Authority's decision 05/456, AWAP 06/001 the Authority applies this
     concept, noting:

          "In making its determination about the content of the advertisements
          subject to complaint, the Panel was required to take into account the
          context, medium, audience and product."

          Accordingly, it noted that the publication in which the advertisements
          had appeared, New Zealand Doctor, was directed at a niche
          readership of health professionals (the consumers in this matter)
          who were informed and knowledgeable readers of medical
          publications, and the editorial issues and advertisements contained
          therein."

22   Only doctors can prescribe Seretide. The Doctor Advertisements appear in NZ
     Doctor magazine and MIMS, publications read predominantly by doctors. The
     third advertisement has also appeared in Pharmacy Today. While other people
     may see the Doctor Advertisements, it is only doctors who can act on them.

23   Accordingly, doctors are the relevant target audience that must be considered
     in relation to any claim that the Doctor Advertisements are misleading or
     deceptive. AstraZeneca accepts this point by canvassing the opinions of a
     limited number of doctors in its "preliminary survey".

24   GSK's Doctor Advertisements have no prospect of misleading doctors.
     Appropriate references are cited to support the information in the
     advertisements. Additionally, published evidence would suggest that doctors
     are generally cautious of pharmaceutical advertisements.
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25   From data collected in focus groups of 30 NZ GPs and 216 completed surveys
     from 350 randomly selected NZ GPs, investigators from the Best Practice
     Advocacy Centre (BPAC)2 in Dunedin found that only 2.6% of physicians trust
     "unsolicited advertisements" as a source of clinical information, and that 59.2%
     distrust such sources (Refer Appendix 4). In fact, Dovey states that, "GPs
     understood the biases in drug company material but were comfortable that they
     could handle pharmaceutical company marketing without being unduly
     influenced."

26   As such, GSK would offer that the educated target audience of NZ Doctor
     magazine would not interpret the Doctor Advertisements in the way
     AstraZeneca suggests. Doctors will interpret the advertisements in the context
     of other trusted information sources such as published, peer-reviewed clinical
     papers, clinical experience (their own or their colleagues), the clinical opinion of
     local and overseas thought leaders, continuing medical education meetings,
     pharmacist facilitators, scientific symposia and materials from organisations
     such as BPAC.

27   AstraZeneca's claims are also not advanced by its reports of the market
     research it has commissioned.

     Prescriber Behaviour
28   For the Doctor Advertisements to be misleading they would have to generate a
     behaviour in the target audience that would be different from that target
     audience's behaviour if they had known more information than what was in the
     Doctor Advertisements, i.e., if they had known all of the published Bateman
     study data.

29   The purpose of the Doctor Advertisements is to encourage doctors to prescribe
     Seretide to their asthma patients who need it. To achieve that purpose, the
     advertising links Seretide with the claim of total control, and cites a clinical
     study to support the claim. The advertisements would only be misleading if a
     doctor who fully understood the Bateman study would not be encouraged to
     alter his or her prescribing of Seretide in the manner or to the extent that the
     doctor would do so, had he or she simply read the advertisement.

30   Advertisements on their own do not lead to increased prescribing of a
     medicine. The affidavit of Dr Howe filed during GSK's successful Australian
     defence3 of an identical claim by AstraZeneca provides a valuable insight into
     doctor behaviour. Paragraphs 54 through 57 demonstrate that advertisements
     are only one small factor that go into a doctor's decision to prescribe a
     particular medicine. (Refer Appendix 6) There is nothing to lead us to believe
     that doctors in New Zealand make their prescribing decisions any differently.

31   It is inconceivable that doctors would prescribe Seretide while labouring under
     a misconception about Seretide's efficacy simply on the basis of seeing the
     Doctor Advertisements.

32   In fact, as previously cited in the paper by Dovey et al, doctors utilise a number
     of information sources to learn about medicines before prescribing them. As
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     guided by their professional standards and duty to patient care, doctors would
     not prescribe solely on the basis of what they see in advertisements.



     Efficacy Claims

33   It is extraordinary that AstraZeneca contends that a claimed therapeutic benefit
     in an advertisement for a prescription drug Is misleading unless that
     therapeutic benefit is achieved:

         in all cases;

         at all doses; and

         with doses for which Seretide is fully funded

34   We address each of these tests in turn.

     "In all cases"
35   Doctors know that an optimal therapeutic result from the use of a medicine is
     never achieved in 100% of cases, and do not interpret a therapeutic claim as
     meaning that a medicine will provide this optimal therapeutic result in all cases.

36   Doctors also do not necessarily rely on medicines achieving an optimal
     therapeutic result in a majority of cases. Many prescription medicines are
     prescribed by doctors when the evidence shows that only a minority of patients
     will receive the intended therapeutic benefit. Examples of these include
     medicines for blood pressure, cholesterol, blood glucose, and psoriasis.

37   Because of this phenomenon, it Is not uncommon for the "headline" therapeutic
     claim in an advertisement for a prescription medicine that is targeted at
     doctors, If taken literally, to be "wrong". This does not make the advertisement
     misleading to the target audience. Doctors are trained to be able to critically
     evaluate published clinical data and to apply those data to their real-world
     clinical practice setting. Some examples include:

     37.1 Hyalgan: One example of a headline therapeutic claim being literally
          "wrong" is Douglas Pharmaceuticals Limited's advertisement for Hyalgan
          that appeared in NZ Doctor on 28 February 2007. The advertisement
          claims that Hyalgan will provide "sustained pain relief that lasts 6-12
          months" and provides a reference to a clinical study. No doctor reading
          this advertisement would interpret it to mean that 100% of patients who
          receive Hyalgan will get sustained pain relief for 6-12 months. In actual
          fact, the study showed that during the one year follow-up period, 30% of
          the subjects did not maintain sustained pain relief for the duration, and
          needed supplementary therapy, (i.e., joint fluid aspiration and/or local
          corticosteroid injections) as compared with 44% in the control group.
          (Refer Appendix 7)

     37.2 Symbicort: Another example is AstraZeneca's recent claim of "Kick
          Asthma" in its marketing of Symbicort. That claim implies (in a literal
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           sense) that Symbicort will free individuals from asthma, i.e., (as defined
           in the New Oxford Dictionary of English as to "succeed in giving up" (a
           habit or addiction)" and Interpreted as "it will cure asthma", or "the
           person will never have it again". That claim is actually not true; GSK is
           not aware of any asthma medicine that can cure asthma. Interestingly,
           the Symbicort "Kick Asthma" advertisements are also available to the
           general public on television and on the AstraZeneca website. The "Kick
           Asthma" claim on the Symbicort website is not referenced to any
           supportive documentation. (Refer Appendix 8)

     37.3 Oxycontin: A further example is the Mundi Pharma advertisement for
          Oxycontin in the 28 June 2006 issue of NZ Doctor, which states, "Imagine
          being in pain for over two years. Imagine being told you don't have to be."
          The Roth reference that is used to support the claim "proven efficacy in
          providing long acting relief from moderate to severe persistent pain" does
          not indicate that all patients are not in pain. The actual results of the Roth
          study state, "Pain intensity decreased from moderate to severe at
          baseline to slight at the end of titration," indicating that patients still
          experienced pain. (Refer Appendix 9)

38   The discussion section in the Bateman study publication reported that more
     than 95% of patients with asthma fail to achieve guideline-defined control. With
     similar issues in other chronic diseases, like hypertension, diabetes,
     hypercholesterolaemia and psoriasis, it would be unrealistic for a doctor to
     expect any medicine to produce total control of asthma in the majority of
     patients treated across all strata.

39   However, by aiming for total control in all patients, the Bateman study
     concluded the following:

           "Our results demonstrate that in the majority of patients with uncontrolled
           asthma across a wide range of severities, comprehensive guideline-
           defined control can be achieved and maintained."

           "In summary, this study has shown that guideline-defined control of
           asthma can be achieved in the majority of patients with uncontrolled
           asthma with combination salmeterol/fluticasone treatment."

     And most importantly:

           “The results of our study suggest that total control should be the aim of
           treatment for all asthma patients. It is a realistic outcome for
           corticosteroid-naive patients, and although it may not be achieved by the
           majority of patients previously on moderate or high doses of inhaled
           corticosteroids, by stepping up treatment and aiming for total control of
           asthma, considerable benefits are achieved in almost all patients. This is
           particularly true for exacerbations, which were virtually eliminated in
           patients who achieved guideline-defined control (either total control or
           well controlled),"

     "At all doses"
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40   Even if the Doctor Advertisements did claim specifically that Seretide is able to
     achieve total control at all doses (which they don't), this claim would not be
     misleading as the Bateman study shows that total control is achievable across
     a range of Seretide doses.

41   With regard to points 24(a) and 24(b) in the AstraZeneca complaint, there is no
     need to state the dosage levels used to achieve total control. Total control was
     achieved at all dosage levels utilised in the Bateman study, and this range of
     dosages is consistent with the dosage range for which Seretide is approved for
     use in the treatment of asthma in New Zealand. (Refer Appendix 10)

42   There is no need to differentiate the level of asthma severity of those who took
     part in the study. Seretide is approved for use in the treatment of asthma
     across a range of dosages, and doctors select the dose that is most
     appropriate to treat the severity of asthma as manifested by the patient they
     are treating at the time.

     "with the doses for which Seretide is fully funded"
43   AstraZeneca claims in paragraph 13(d) of its complaint that GSK's
     advertisements imply Seretide is able to achieve total control of asthma with
     the doses for which Seretide is fully funded and that this is misleading.

44   GSK has three responses to make to AstraZeneca's claim:

     60.1 AstraZeneca is using GSK's compliance with mandatory requirements to
          create an implication that would not actually be taken from the
          advertisements by a reasonable reader;

     60.2 GSK's advertisements do not imply that Seretide is able to achieve total
          control of asthma with the doses for which Seretide is fully funded; and

     60.3 even if GSK's advertisements did imply that Seretide is able to achieve
          total control of asthma with the doses for which Seretide is fully funded,
          this statement would be true.

45   These points are addressed in turn.

     AstraZeneca using GSK's compliance with mandatory criteria to create an
     artificial implication:
46   The funding status of Seretide must be included in the advertisement in order
     to comply with the RMI Code of Practice that requires:

          "Any limitations to the terms of approval and pharmaceutical schedule
          listing should be clearly disclosed and easily identifiable by the reader.
          No attempt should be made to minimise this disclosure as it should be a
          prominent feature of any advertisement or promotional material and a
          genuine communication vehicle to advise prescribers of the support and
          information. The disclosure of this Information must accurately reflect the
          approval and pharmaceutical schedule listing but may be a paraphrase or
          precis of that information." (RMI Code Principle 6.2.3); and
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           "A full advertisement must contain the following within the body of the
           advertisement:
                 (k) A clear statement regarding the funding status of the product."
                 (RMI Code Principle 6.2.4.4)

47   GSK's advertisements comply with these mandatory criteria by bearing the
     statement "FULLY FUNDED WITH SPECIAL AUTHORITY: Seretide 50/25,
     125/25mcg inhaler and Seretide 100/50, 250/50mcg Accuhaler" to clearly
     indicate for prescribers those preparations that are fully funded. All of the
     advertisements also contain the statement: "SeretideTM (fluticasone propionate/
     salmeterol xinafoate inhaler 50/25, 125/25mcg per actuation and AccuhalerTM
     100/50, 250/50mcg per actuation) is a fully funded medicine; Special Authority
     criteria apply. Seretide 250/25mcg Inhaler is a private purchase medicine; a
     prescription charge will apply."

48   The term "Fully Funded with Special Authority" has a special meaning to
     doctors as defined by Pharmac. Those words mean that certain criteria will
     need to be met in order for a patient's Seretide prescription to be "fully funded".
     All doctors are required to know this - the Pharmaceutical Schedule (which
     every doctor receives every three months) sets out the rules for publicly funded
     pharmaceuticals. The Pharmaceutical Schedule also explicitly sets out the
     process that doctors must use when applying for Special Authority.

49   Special Authority applications by their very nature mean that not every person
     will necessarily qualify for a Special Authority number that then entitles the
     patient to receive fully funded treatment. The Pharmaceutical Schedule also
     clearly states "for some special authority community pharmaceuticals, not all
     indications that have been approved by Medsafe are subsidised". There is no
     room to Infer AstraZeneca's suggested statement from the Doctor
     Advertisements' wording, especially when the target audience is very familiar
     with the funding regime.

     Advertisements do not imply that Seretide is able to achieve total control of
     asthma with the doses for which Seretide is fully funded:
50   AstraZeneca has wrongly linked the required funding statement to the
     therapeutic claims made in an advertisement. These are quite separate issues.

51   The Pharmaceutical Schedule (which specifies the funding status of
     pharmaceuticals) does not state what a pharmaceutical is approved for, nor
     does it specify whether a patient's prescribed dose is fully funded. The
     Pharmaceutical Schedule specifies Seretide's funding status on the basis of a
     patient meeting criteria set by Pharmac, and the preparation that the patient is
     prescribed. It is the doctor who decides the preparation to prescribe and what
     actual dose is administered to the patient.

52   Seretide, and for that matter any other medicine under a Pharmac Special
     Authority restriction, can be prescribed by any NZ physician as a private
     purchase medicine. Even today, presentations that are not reimbursed by the
     Government, e.g., Seretide 250/25 inhaler, are available as private purchase
     medicines and can be prescribed by any NZ physician.
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53   The difference between mandatory funding statements and therapeutic claims
     made in the advertisements is clear because the statement is in a different font
     colour and size from all other print on the advertisements, and separated by a
     border. This separation clearly conveys that any of the other statements made
     in the advertisement have nothing to do with the funding criteria.

     Statement would be true:
54   Even if the advertisements did make the claim AstraZeneca alleges, the claim
     would be true, again as fully supported by the Bateman study. The Bateman
     study demonstrated that Seretide is able to produce total control across a
     range of Seretide doses, including those that are fully funded in New Zealand.
     Both prescribing options (fully funded and private purchase) are available to
     doctors to use at their discretion when discussing treatment options with their
     asthma patients.

     The Advertisements
55   GSK's Doctor Advertisements do not mislead; they provide a valid therapeutic
     claim; the claim is substantiated by a landmark published, peer-reviewed,
     clinical study; and the advertisements direct doctors to the source of the claim
     where they can find more detailed information about the study. The Doctor
     Advertisements are therefore typical of pharmaceutical company
     advertisements for prescription drugs targeted at doctors.

56   It is impossible to put all relevant prescribing information in an advertisement.
     That is why footnotes are used in some instances. Doctors know footnotes are
     used, and they refer to them. The footnotes in the advertisements are also in a
     large font and easily readable.

57   Not providing all of the details of a relevant study cannot of itself be misleading,
     otherwise advertisers would need to publish the entire study in each
     advertisement. AstraZeneca seems to suggest in paragraph 24 of its complaint
     that GSK must provide a detailed account of the Bateman study methodology
     and results. To do so would be impossible within the confines of a one page
     advertisement, and would place a greater expectation on GSK than on any
     other pharmaceutical company in New Zealand, and one that AstraZeneca has
     demonstrated that it does not impose upon itself as evidenced by some of its
     own advertisements In NZ Doctor magazine. Instead, the GSK Doctor
     Advertisements provide an accurate summary of the study results and
     accurately references the Bateman study where doctors can read and interpret
     the study's more complete data set for themselves.

58   The Federal Court of Australia stated

           "... the footnotes to which one is directed and which appear in an easy to
           read type size on each of the original documents do not allow inferences
           to be drawn that representations were made to the effect alleged."' 4

59   This conclusion must also be applicable in New Zealand where the further
     statement is easy to read, and in fact particularly prominent in the case of the
     third advertisement.

     First Advertisement
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60   AstraZeneca complains about three phrases in the first advertisement:

     60.1 "Seretide for total asthma control in one inhaler";

     60.2 "Upgrade your patients to Seretide for Total Control"; an

     60.3 "Fully Funded with special authority: Seretide 50/25, 125/25mcg inhaler
          and Seretide 100/50, 250/50mcg Accuhaler".

61   None of these phrases mislead. Seretide can achieve total asthma control In
     one inhaler - as the Bateman study showed. The phrase is appropriately
     referenced to the Bateman study.

62   Two Courts in Australia5 have dismissed AstraZeneca's claim that using the
     words "total control" to promote Seretide are misleading. Both Courts expressly
     rejected the interpretations suggested by AstraZeneca, some of which are
     exactly the same as what AstraZeneca is suggesting in this complaint. (Refer
     Appendix 5)

63   The claim about upgrading patients sits immediately above the words "Seretide
     = Flixotide + Serevent". The obvious meaning that the phrase complained of
     together with the equation conveys Is that patients can be "upgraded" onto a
     single Inhaler containing the same medicines that the patient is already
     receiving through two inhalers. The words "total control" are again referenced
     to the Bateman study. The phrase is not misleading.

64   The fully funded reference correctly refers to all of the preparations that the
     New Zealand Government will fund. The phrase also explicitly says "with
     Special Authority". The advertisement also states that "Seretide 250/25mcg
     inhaler is a private purchase medicine; a prescription charge will apply."

65   The funding statements in the Doctor Advertisements are required to comply
     with the RMI Code of Practice, and are not a part of, or related to, any claims
     made in the advertisements or any references supporting those claims.

66   The first advertisement is no longer being run, and there is no intention to run it
     in the future.

     Second Advertisement
67   AstraZeneca complains about the phrase "Upgrade your asthma patients to
     Seretide for TOTAL. CONTROL" and the same fully funded statement as in the
     first advertisement. It should be noted that the words "total control" are not
     emphasised in the advertisement as AstraZeneca's complaint suggests. The
     second advertisement must be even less likely to mislead than the first
     advertisement because the total control claim is referenced to a further
     statement in the advertisement, which provides the context of the Bateman
     study results:

           "The GOAL study examined whether guideline defined asthma control
           could be achieved in 3416 patients with uncontrolled asthma. On
           Seretide 41% of patients achieved total control and 71% achieved well
           controlled asthma for periods of 7 out of 8 weeks after 12 months. Total
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           control was defined as experiencing none of the 7 listed symptoms for at
           least 7 out of 8 weeks."

68   The Federal Court of Australia unanimously held that the words "total control"
     when footnoted to an almost identical statement are not misleading because
     the footnoted statement is true. AstraZeneca also conceded that the statement
     was true.

69   GSK is surprised that AstraZeneca conceded that the statement was true in
     Australia, and therefore by definition not misleading, but that it has now
     complained about exactly the same issue in New Zealand one year later.

70   The information in this statement is consistent with the information that first
     appeared in GSK Seretide total control advertisements or promotional material
     in September 2004.

71   This second advertisement is not being run, and there is no intention to run it in
     the future.

     Wraparound Flyer
72   AstraZeneca alleges a problem with the statements:

     72.1 "Help your patients aim to live symptom free"; and

     72.2 "Upgrade your asthma patients to Seretide for TOTAL CONTROL"

73   The use of the words "help" and "aim" clearly convey that a symptom free state
     might not be achieved for any particular patient. The statement is also
     consistent with the current GINA asthma treatment guidelines, which
     encourage physicians to aim for asthma control. (Refer Appendix 3)

74   The phrase does suggest that some patients will achieve relief from their
     asthma symptoms. That suggestion is true. The total control claim is again
     appropriately referenced to Bateman study results that AstraZeneca has
     previously conceded are true.

75   The use of the word "upgrade" is also in the context of advertisement that
     shows pictures of inhalers in the same equation used in advertisements 1 and
     2. The distinctive colours of the inhalers make them easily recognisable as
     Flixotide and Serevent. Accordingly, the claim will again be interpreted to mean
     that patients can be "upgraded" onto a single inhaler instead of two inhalers.

76   The wrap around flyer is currently being run and GSK intends to run it in the
     future.

     Third Magazine Advertisement
77   AstraZeneca complains again about the fully funded reference and also the
     phrase "Is your asthma goal total control? Consider Seretide".

78   Like the wrap around flyer, the use of the word "goal" in the context of a
     question does not convey that all patients will achieve total control as
     AstraZeneca tries to suggest.
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79   The phrase can only mean that total control is achievable for some patients
     when Seretide is used. That claim is true, and the claim is referenced to the
     supporting Bateman study. The statement is also consistent with the current
     GINA asthma treatment guidelines, which encourage physicians to aim for
     asthma control.

80   The third advertisement also goes further than the earlier two advertisements
     by expressing the results of the Bateman study (which AstraZeneca conceded
     were true) with greater prominence within the body copy of the advertisement.
     Again, the claim is now supported within the body copy by the further statement
     referred to above.

81   AstraZeneca again takes issue with "a statement that Seretide is `fully funded
     with special authority' and lists the doses for which Seretide is fully funded."
     GSK has addressed this issue earlier in this submission.

82   This third advertisement is currently being run and GSK intends to run it in the
     future.

     The Seretide Guide
83   GSK is at a complete loss as to what the issues are with the Seretide Guide.
     AstraZeneca appears to have a problem with the phrase "total control", and yet
     this phrase is never used in the Seretide Guide.

84   Surprisingly, AstraZeneca seems to say that there is a problem with GSK
     stating:

          "Seretide can help you get back to being you"; and

          "Used regularly Seretide may be able to help you feel free from the
          symptoms of asthma and help you to do what you want to do"

85   Both of these statements are referenced to the Bateman study, as AstraZeneca
     points out. GSK's statements accurately reflect the conclusions of authors in
     the Bateman study:

          "The overall AQLQ [Asthma Quality of Life Questionnaire] score for all
          groups and strata approached or surpassed the value of 6, suggesting
          that asthma no longer had a significant impact on quality of life."

          "this study has shown that guideline-defined control of asthma can be
          achieved in the majority of patients with uncontrolled asthma with
          [Seretide] treatment."

          "the approach of aiming for total control and maintaining treatment
          resulted in the virtual elimination of exacerbations and near-normal
          quality of life in the majority of patients and brought substantial benefit
          even to those who failed to achieve this high level of control."

86   In fact, direct comparison of GSK's statements with the Bateman study
     statements shows that GSK could have made stronger claims in the Seretide
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     Guide. GSK has not claimed that Seretide can "virtually eliminate
     exacerbations and provide a near-normal quality of life in the majority of
     patients", but it could legitimately do so.

87   The actual statements AstraZeneca takes issue with do not claim or imply
     anything other than Seretide being able to assist some patients improve their
     asthma symptoms. The Bateman study also shows that Seretide does, in fact,
     assist most patients in improving their quality of life.

88   The Seretide Guide Is intended for patients who have been prescribed
     Seretide. Those patients have recently seen their doctor about their asthma. All
     of them would have received an explanation from their doctor about Seretide
     and what its expected result will be. To that target audience, the Seretide
     Guide has no potential to mislead.

     The Bateman Study - An Accurate Analysis of a Landmark Study
89   The definitions of control in the Bateman study were derived from the treatment
     goals of the Global Initiative for Asthma/National Institute of Health guidelines:
     "totally controlled" or "well-controlled" or uncontrolled (if neither definition was
     fulfilled). The discussion section of the Bateman study states:

           "Because no widely accepted measures of asthma control were available,
           two composite measures from the Global Initiative for Asthma/National
           Institutes of Health guideline goals of treatment were developed and
           proposed as targets for control. As single measures are likely to
           overestimate control, a composite measure was selected to assess the
           total impact of this disease on patients. Totally controlled asthma was the
           complete absence of all symptoms of asthma for at least 7 of 8 weeks.
           Well controlled was a pragmatic adaptation based on what is permitted
           by the guidelines as control, also sustained for at least 7 of 8 weeks.
           Such stringent and sustained measures of asthma control have never
           previously been assessed in a clinical trial."

90   In paragraph 18 of its complaint, AstraZeneca cites data from the Bateman
     study. GSK has no issue with the percentages of patients responding, as these
     numbers are reflected in the Bateman paper. What is interesting is that
     AstraZeneca has not reflected all of the response rates, which include stratum
     1 as well, but appears keen to report that patients in Phase I had the ability to
     have their dose increased to a maximum dose of Seretide 500/50 bd.

91   AstraZeneca omits the fact that a patient's dose was increased to a maximum
     of Seretide 500/50 bd only in the event that the patient did not achieve a status
     of total control. If patients achieved a status of total control, their dose was
     maintained at the dose at which they achieved total control.
92   AstraZeneca also introduces its own concepts of moderate or severe asthma to
     describe strata 2 and 3, respectively. To be clear:

     92.1 stratum 1 reflects those patients who were not receiving an inhaled
          corticosteroid prior to study entry;

     92.2 stratum 2 reflects those patients who were receiving an inhaled
          corticosteroid <_ 500 mcg/day of beclomethasone equivalent;
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     92.3 stratum 3 reflects those patients who were receiving an inhaled
          corticosteroid > 500 mcg/day and 1000 mcg/day of beclomethasone
          equivalent.

93   To more completely summarise the results,

          (a) After Phase I 'total control' was achieved in
                   (i) 42% of patients in stratum 1;
                   (ii) 32% of patients in stratum 2; and
                   (ii) 19% of patients in stratum 3.

          (b) After Phase II 'total control' was achieved in
                   (i) 50% of patients in stratum 1;
                   (ii) 44% of patients in stratum 2; and
                   (ii) 29% of patients in stratum 3.

94   GSK is puzzled by the wording of paragraph 20 of AstraZeneca's complaint, as
     it seems to contradict itself. AstraZeneca presents the fact that 41% of patients
     overall achieved total control, including 29% of patients in stratum 3, yet goes
     on to suggest that patients are unable to achieve total control regardless of the
     severity of their asthma. GSK would contend that the data presented by
     AstraZeneca in this paragraph as well as in paragraph 18 of its complaint
     would, in fact, support the claim that patients are able to achieve total control
     across a range of asthma severities.

95   Paragraph 21 of the AstraZeneca complaint, on the other hand, represents
     what appears to be AstraZeneca's blatant misrepresentation of the data from
     the Bateman study.

     95.1 In paragraph 21, AstraZeneca selectively quotes from the Bateman study
          (p. 838) to suggest "that the majority of patients who achieved total
          control were only able to do so using the highest dose of Seretide". This
          quote is taken out of context from the publication, and AstraZeneca
          misinterprets the data to wrongly assert that patients had to have been on
          the highest dose of Seretide to have a chance at achieving total control.
          AstraZeneca's selective misrepresentation of the data to the Authority
          omits important information that actually puts this selective quote in its
          proper context.

     95.2 AstraZeneca has omitted the first part of the sentence, which states, "Of
          those patients that achieved either well-controlled or totally controlled
          asthma, most (well controlled: 60%, 45%, and 50%; and totally controlled:
          40%, 40%, and 53% for strata 1, 2, and 3, respectively) did so at the
          lowest dose of combination treatment used for the stratum;
          however, because fewer than half of the entire study population achieved
          totally controlled asthma during phase I, most patients completed the trial
          on the highest dose of salmeterol/fluticasone or fluticasone..."

     95.3 Said another way, the Bateman study not only suggests, but In fact
          confirms, that patients were able to achieve total control across a range
          of Seretide dosages, and that the majority of patients who achieved total
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           control did so not at the highest dose of Seretide (as AstraZeneca would
           have the Authority believe), but in fact at the lowest dose of Seretide
           used for the stratum. (Refer Appendix 11 - Chart A)

     95.4 "Patients entered phase II either after achieving totally controlled asthma
          or after 12 weeks on the maximum dose of study medication. During
          phase II, patients remained on the dose at which they achieved totally
          controlled asthma or the maximum dose of study medication until the
          end of the 1-year double-blind treatment period." Thus, by definition, not
          all patients who completed the study would necessarily have achieved
          total control despite having been on the maximum dose allowed. The
          figures that AstraZeneca quotes in its complaint do not consider this,
          and thus misrepresent the data as reported in the Bateman publication.
          (Refer Appendix 11 - Chart A)

     95.5 Specifically, data from Figure 1B from the Bateman study present the
          more complete picture of those patients who achieved total control. As
          you can see in Chart A, 42%, 32%, and 19% of the patients enrolled in
          the trial achieved total control by the end of Phase I (i.e., the dosage
          titration phase of the study) in stratum 1, 2, and 3, respectively. The
          average across all strata was that 31% of patients achieved total control
          by the end of Phase I.

     95.6 By the end of the study, additional patients achieved total control of their
          asthma, with 50%, 44%, and 29% achieving total control in stratum 1, 2,
          and 3, respectively. Overall, 41% of patients achieved total control across
          all strata.

96   The dosage of Seretide at which patients achieved total control of their asthma
     has also been misrepresented by AstraZeneca.

     96.1 In Chart B (Refer Appendix 12), (adapted from Figure 1B of the
          Bateman study) you can see that for the patients in stratum 1 who
          achieved total control during Phase I of the study (and thus continued on
          that same dose through Phase II of the study to completion of the study
          at 1 year), 40% achieved total control at the lowest dose (200mcg/day),
          an additional 40% achieved total control at the next lowest dose
          (500mcg/day), and only 20% required the highest dose (1000mcg/day) to
          achieve total control.

     96.2 Similarly for stratum 2, 40% achieved total control at the lowest dose
          (200mcg/day), an additional 36% achieved total control at the next lowest
          dose (500mcg/day), and only 24% required the highest dose
          (1000mcg/day) to achieve total control.

     96.3 And in stratum 3, i.e., in those patients with the most severe asthma
          symptoms and needing the highest dose of inhaled steroid to treat their
          symptoms, the majority of patients who achieved total control, i.e., 53%,
          did so at the lowest dose (500mcg/day) in this stratum.

     96.4 Summarising this information, of those patients who achieved total
          control in Phase I of the study, the majority, i.e., 70% across all strata, did
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           so at a dose that was less than the maximum dose allowed in the study,
           not at the maximum dose as AstraZeneca would want the Authority to
           believe.

97   As you can see in Chart C (Refer Appendix 13), even when the data include
     those patients who achieved total control during Phase II of the study on a
     higher dose of inhaled steroid, of those patients who achieved total control by
     the end of the 1-year study, the majority (i.e., 52% across all strata), did so at
     a dose lower than the maximum dose allowed in the study.

     The Clinical Context
98   Putting this in a realistic context, doctors do not prescribe a medicine only
     because a majority of patients receiving the prescribed medication will be
     expected to receive the optimal therapeutic outcome. Doctors prescribe on the
     basis that a statistically significant number of patients achieve a particular
     outcome with a prescribed medicine. This is why clinical trials typically measure
     results on the basis of a statistically significant effect over placebo or a
     comparator medicine, not simply whether a majority of patients achieve the
     optimal outcome.

99   From a clinical perspective, the response rates for total control are not
     dissimilar to what is seen with the treatment of other chronic diseases. In the
     Bateman study the average response with Seretide across all strata was 71%
     for well controlled asthma and 41% for totally controlled asthma. Obviously, the
     higher the expectation with the total control criteria, the lower the response rate
     expected.

100 As stated in the Bateman study, "In addition, the approach of aiming for total
    control and maintaining treatment resulted in the virtual elimination of
    exacerbations and near-normal quality of life in the majority of patients and
    brought substantial benefit even to those who failed to achieve this high level of
    control."

101 Further examples of prescribed medicines that do not achieve the optimal
    therapeutic outcome In a majority of patients include the following:

     101.1 Psoriasis: In moderate to severe plaque psoriasis, Gottlieb evaluated the
           drug Raptiva (efalizumab) over three years and, in the As-treated (AT)
           population, showed that by 36 months, 73°h of patients achieved a PASI
           75 and that 40% achieved the higher goal PASI 90. As with the Bateman
           results, the higher goal resulted in a lower response rate. (Refer
           Appendix 14)
           (Note: The Psoriasis Area and Severity Index (PASI) Is an assessment
           score representing the extent, redness, thickness and scaliness of a
           person's psoriasis on a single scale, usually scored from 0 (no psoriasis)
           to 72. A'PASI 75' is an outcome measure that reflects the proportion of
           patients achieving a 75% reduction in the PASI score. Thus, a 'PASI 90,
           would reflect the higher goal of achieving a 90% reduction in PASI score,
           or nearly totally controlled psoriasis.

     101.2 Hypertension: Chobanlan et al, reporting In the journal Hypertension
           2003 on the Joint National Committee 7 for the treatment of high blood
                                        26
                                                                              07/165




           pressure, indicated that two thirds of hypertensive patients are not being
           controlled to blood pressure levels less than the JNC7 goal of 140/90
           mmHg. (Refer Appendix 15)

           In a comparative study, Brunner reported in Clinical Drug Investigation
           2006 on the 24-hour antihypertensive efficacy of olmesartan and
           candesartan. The study concluded that when evaluated against the
           European Society of Hypertension/European Society of Cardiology 24-
           hour ambulatory blood pressure measurement goals, the goals were
           achieved by 25.6% and 14.9% of olmesartan and candesartan patients,
           respectively. (Refer Appendix 16)

     101.3 Diabetes: The American Diabetes Association 2007 Standards of
           Medical Care indicated that only 37% of adults with diagnosed diabetes
           achieved an A1c goal of <7%, only 36% achieved a blood pressure goal
           of <130/80 mmHg, just 48% had a cholesterol <200mg/dL, and most
           distressing, only 7.3% of diabetes subjects achieved the composite of all
           three treatment goals. (Refer Appendix 17)

     101.4 High Cholesterol: Andrews et al reported in the American Journal of
           Medicine 2001 that in a recent survey of 4888 patients treated with statin
           drugs for hypercholesterolaemia, only 38% reached the recommended
           LDL cholesterol levels. (Refer Appendix 18)

    Other Jurisdictions
102 AstraZeneca's complaint is the latest challenge in what appears to be a global
    campaign to halt GSK's effective marketing of Seretide.

103 AstraZeneca has selectively presented information out of context from other
    jurisdictions and wrongly implies that the New Zealand advertisements must be
    in breach of standards because different advertisements in the same campaign
    three years ago were in breach in two European countries. Those rulings were
    based on the specific materials in question and judged against the promotional
    regulations that apply in those countries.

104 The New Zealand advertisements are different from the advertisements
    considered in the Swedish and United Kingdom cases. It is misleading for
    AstraZeneca to only provide the Authority with two decisions in its favour
    about advertisements with different content and format. It is notable that
    AstraZeneca has not provided copies of these advertisements.

    United Kingdom
105 Following the United Kingdom decision AstraZeneca refers to, GSK is still able
    to use the phrase "total control" in order to promote Seretide. In doing so, GSK
    must reference the phrase to the Bateman study and the study's results. This is
    exactly what GSK's advertisements do in New Zealand (with the exception of
    the first advertisement that is no longer being run).

    Sweden
106 The Swedish decision referred to Involved a completely different advertisement
    where the advertisement's specific imagery (that is not used in the New
    Zealand advertisements) was found to assist in misleading a reader. The
                                          27
                                                                             07/165




     decision did not prevent GSK from advertising Seretide and total control in
     Sweden.

107 In fact, the ad that was allowed following the decision was headed by the
    phrase:

           "The goal of asthma therapy is full control of the disease."

108 And included the following body copy:

           "The goal of asthma therapy is to gain full control of the disease. GOAL
           shows that significantly more patients with asthma from the age of 12 can
           reach total control through regular and long term maintenance therapy
           with Seretide compared to Flutide (44°h vs. 28%). Total control, as
           defined in GOAL, is a combined target where all included efficacy
           variables have been reached and maintained for at least 7 out of 8
           weeks. For patients with asthma this mean no daytime symptoms, no use
           of short acting rescue medication, a morning PEF over 80%, no night
           time awakenings, no exacerbations, no acute visits to the hospital and no
           bothersome side effects of the medication." (Refer Appendix 19)

109 Again, this is exactly what GSK NZ's advertisements do.

    Australia
110 AstraZeneca claims that the Australian court decisions are not relevant, but
    these decisions are absolutely applicable. The question in Australia was
    whether the advertisements were likely to mislead in terms of the Trade
    Practices Act. The same tests apply under the Trade Practices Act and the
    New Zealand Fair Trading Act, and a New Zealand judge would need good
    reason to find differently from the Australian Courts when determining the same
    Issue under equivalent legislation.

111 The Australian Courts gave careful judicial consideration of whether using the
    phrase "total control" to promote Seretide Is misleading. (Refer Appendix 5)
    Not surprisingly, the Federal Court and (on appeal) the Full Federal Court
    found that It was not. The Full Federal Court of Australia stated:

           [42] Viewing each of the flyers and the advertisements as marketing
           documents directed by the Respondent to ordinary or reasonable
           members of the community of general practitioners throughout Australia
           in the context of the product and sales history indicated above, we are
           unable to find that any of them make the representations alleged In
           paras 5(a), (b), (c) or (d) of the statement of claim as set out in [11]
           above.6

           [43] In our opinion representations were not made in the terms
           alleged simply by the use of the words "Seretide total control";
           however recorded. We are inclined to the view that "Seretide total
           control" is in effect an alternative brand name adopted by the Respondent
           for its medication "Seretide": In any event the footnotes to which one
           is directed and which appear in an easy to read type size on each of
                                         28
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           the original documents do not allow inferences to be drawn that
           representations were made to the effect alleged."

112 It is unclear to GSK as to how a phrase can not mislead doctors in Australia,
    but still mislead doctors in New Zealand.

    GSK's Response to AstraZeneca's Correspondence
113 AstraZeneca alleges that GSK has not taken any action over the concerns it
    raised with GSK. This is another misstatement on the part of AstraZeneca.
    GSK did not state that it would take no action.

114 AstraZeneca demanded that GSK cease the use of this material Immediately
    and confirm that GSK would cease making "total control" or similar claims
    without delay.

115 In response, GSK advised AstraZeneca that it would take AstraZeneca's views
    into account when formulating its advertising. GSK also informed AstraZeneca
    that the advertisement it complained about was not scheduled to be run again
    (and it has not run again), and that GSK would accurately reflect the outcomes
    of the Bateman study. GSK went further and ensured that advertisements 2
    and 3 reflected the content of previous advertisements that AstraZeneca
    appeared to have no issue with for nearly three years.

116 In fact, rather than relegating the qualifying information to footnote status, GSK
    deliberately made the clarifying information a formal part of the advertising
    body copy to ensure that doctors would see the actual percentage results of
    total control achieved.

    Conclusion
117 GSK's claims are substantiated, they are not misleading, and they are not
    exaggerated.

118 GSK does not claim that Seretide will achieve total control of asthma in all
    cases and the inferences that AstraZeneca suggests should be taken for the
    advertisements are fanciful.

119 GSK does claim that Seretide is able to achieve total control in a clinically
    significant proportion of cases, and in particular, heralds a significant
    achievement relative to the historical burden of asthma not only in New
    Zealand (POMS data) but worldwide, where it Is estimated that over 95% of
    patients with asthma fail to achieve guideline-defined asthma control. That
    claim is supported by the research GSK prominently refers to In Its
    advertisements. The landmark Bateman study has shown that guideline-
    defined control of asthma, including total control, can be achieved with the use
    of Seretide in patients with uncontrolled asthma.

1    The POMS study in New Zealand (Holt S et al. The Patient Outcomes Management
     Survey. NZ Med J. 2003;116(1174):1-8) revealed that:
         93% of adults with asthma were sub optimally controlled - 71% were not well-
          controlled, and 19% had asthma that was markedly out-of-control;
         90% of children with asthma were sub optimally controlled - 42% were not well
          controlled, and 4% had asthma that was markedly out-of-control;
                                            29
                                                                                        07/165




         49% of adults and 71% of children who were not well controlled were under-
          treated;
         89% of adults and 75% of children who were markedly out-of-control were under-
          treated; and
         despite this level of illness, the vast majority of adults and children were
          satisfied with their level of asthma control and thought that their asthma was
          well controlled. (Refer Appendix 2)
         nz
2   bpac is an independent organisation that promotes healthcare interventions which
    meet patients needs and are evidence based, cost effective and suitable for the New
                           nz
    Zealand context. Bpac has four shareholders:
         ProCare Health
         South Link Health
         Independent Practitioner Association Council (IPAC)
         University of Otago
        nz
    bpac is currently funded through contracts with Pharmac and DHBNZ.

3   AstraZeneca Pty Limited v GlaxoSmithKline Pty Limited [2006] FCAFC 22 (Refer
    Appendix 5)

4   Supra. Note 3 at paragraph 43 (Refer Appendix 5)

5   Supra. Note 3; AstraZeneca Pty Limited v GlaxoSmithKline Pty Limited [2005] FCA
    1645 (Refer Appendix 5)

6   AstraZeneca's allegations were that GSK represented:

    a.    That all or virtually all asthma patients will achieve 100% control or total control
          of all asthma symptoms by using Seretide;

    b.    Alternatively, that a majority (i.e. greater than 50%) of all asthma patients will
          achieve 100% control or total control of all asthma symptoms by using Seretide;

    c.    Alternatively, that a sufficiently high proportion of all asthma patients will achieve
          100% control or total control of all asthma symptoms by using Seretide to justify
          the use of the brand slogan "Seretide total control";

    d.    That 41% of all patients taking part in the study known as the "Gaining Optimal
          Asthma Control" study published in the American Journal of Respiratory &
          Critical Care Medicine in 2004 (GOAL Study) achieved 100% control of all
          asthma symptoms by using Seretide;

    e.    Alternatively, that 41% of all patients taking part In the GOAL Study achieved
          "total control" (as that term is defined In the Seretide Advertisements) of all
          asthma symptoms by using Seretide;

    f.    That 71% of all patients taking part In the GOAL Study achieved "well controlled
          asthma" as that term is defined in the Seretide Advertisements) of all asthma
          symptoms by using Seretide; and

    g.    That the patient results of the GOAL Study identified In paragraphs 5(d), 5(e)
          and 5(f) and (sic) will be achieved or will be likely to be achieved in clinical
          practice.

                                     APPENDICES
                                        30
                                                                            07/165




1    Bateman Study - Bateman ED et al. Am J Respir Crit Care Med. 2004; 170;
     836-844

2    POMS Study publication - Holt Set al. NZ Med J. 2003; 116:1174.

3    GINA. Global Strategy for Asthma Management and Prevention. Global
     Initiative for Asthma 2006. (excerpted pages)

4    Dovey paper on clinical information needs of NZ General Practitioners -Dovey
     SM. NZ Fam Phys. 2006;33:18-24.

5    Federal Court of Australia Decisions: AstraZeneca Pty Limited v
     GlaxoSmithKline Pty Limited [2005] FCA 1645; AstraZeneca Pty Limited v
     GlaxoSmithKline Pty Limited [2006] FCAFC 22

6    Dr Howe affidavit.

7    Hyalgan Advertisement, NZ Doctor, 28 February 2007.

8    Symbicort Website - www.symbicort.co.nz. Accessed 21 May 2007.

9    Oxycontin Advertisement, NZ Doctor, 28 June 2006.

10   Seretide Data Sheets and Consumer Medicines Information.

11   Chart A - Patients on the Maximum Doses of Seretide versus Those Patients
     Achieving Total Control of Asthma

12   Chart B - Distribution of Seretide Dosage in Patients Who Achieved Total
     Control in Phase I of the Study

13   Chart C - Distribution of Seretide Dosage in Patients Who Achieved Total
     Control by Study End (1-year)

14   Raptiva website - http://www.raptiva.com/raptiva/hcp/hcp_about.jsp,
     Downloaded 3 May 2007.

15   Excerpt from the JNC7 Report on treatment of high blood pressure (pages
     1206, 1207 and 1216) - Chobanian AV et al. Hypertension 2003;42:1206-1252.

16   Olmesartan versus candesartan comparative study - Brunner HR. Clin Drug
     Invest. 2006;26:185-193.

17   Position statement on the Standards of Medical Care in Diabetes - 2007 (pages
     S4, S33 and S34) - Diabetes Care. 2007;30(Suppl 1):S4-S41.

18   Achieving cholesterol goals - Andrews TC et at. Am J Med. 2001;111:185-191.

19   GSK Sweden Seretide Total Control Ad post-IGM decision


Oral Submissions
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Both the Complainant and the Advertiser presented oral submissions and
responded to questions posed by members of the Panel.

Deliberation


The Panel confirmed that prior to its deliberation, it had taken into account all the
submissions made in relation to this matter. The Panel identified the five
advertisements that were the subject of this adjudication and the Principles and
Requirements against which each of the advertisements were assessed.

The advertisements included:

1.    A full page advertisement published in New Zealand Doctor magazine on 28
February 2007. (Advertisement A).

2.     A Seretide guide for new users (Advertisement B:);

3     A full page advertisement published in New Zealand Doctor magazine on 28
March 2007. (Advertisement C)

4.    A wrap around flyer distributed with New Zealand Doctor magazine on 28
March 2007 (Advertisement D).

5.      A full page advertisement published in New Zealand Doctor magazine on 11
April 2007 (Advertisement E)

The Chairman addressed the parties in relation to the Code for Advertising
Therapeutic Products. All parties agreed that the Codes relevant to the five
advertisements were as follows:

First, it was the Panel‟s view that the Principles of the Code overarch all therapeutic
advertising. Accordingly the Principles were considered to be individually or
collectively fundamental to every therapeutic determination. In terms of the
advertisements identified above, the Panel ruled that Principle 2 of the Code
addressed the issues outlined in the complaint. This being the case, the Panel did
not consider it necessary to determine the advertisements with regard to Principle 3
of the Code.

Advertisements A, C, D and E were directed to healthcare practitioners, therefore in
terms of the Code Part B3 was applicable and in particular Requirement 4.i.(ii).
Accordingly, the Panel did not consider it necessary to determine the
advertisements in association with Requirement 3 of the Code.

Advertisement B, the Seretide Guide for new users, was the only advertisement
directed to consumers and as such Part B1 of the Code was applicable and in this
instance Requirement 4.i.(ii) satisfied the issues raised in the complaint. As a result,
the Panel did not consider it necessary to determine the advertisement in relation to
Requirement 3 of the Code.
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The Panel then turned to the five advertisements and considered each one
individually.


Advertisement A

This advertisement was the first in a series promoting the asthma drug Seretide.
The headline stated, “SERETIDE FOR TOTAL ASTHMA CONTROL IN ONE
INHALER”. The Panel observed the reference to the Bateman study but, in
particular, noted that nowhere in the advertisement was there an explanation of the
words “Total Asthma Control”.

The Panel considered the Advertiser‟s written submission in relation to this
advertisement. It observed that the advertisement had been withdrawn and that it
would not be run again. This was confirmed by the Advertiser in response to a
question from the Chairman.

Accordingly, the Panel was satisfied that the complaint had been settled in a manner
consistent with the principles of self-regulation and, as such, ruled that the complaint
had been settled.


Advertisement B

The Panel confirmed that this was the only advertisement directed at „the public‟. It
was produced in the form of a pamphlet and stated quite clearly that it was „a guide
for new users‟. It was available to the general public through a medical practitioner
or a doctor‟s waiting rooms. Of concern to the Complainant were the following
phrases:

(i) “Seretide can help you get back to being you” and (ii) “Used regularly Seretide
may help you feel free from the symptoms of asthma and help you to do what you
want to do”.

The Panel referred to Part B1-Requirement 4.i.(ii) of the Code. It was of the opinion
that the phrases were sufficiently qualified by the use of the words “help” and “may”
so as not to mislead or deceive the public. Similarly, the phrases were sufficiently
qualified to avoid the proposition that the product was effective in all cases.

As neither claim was considered to be absolute, the Panel was satisfied that the
phrases were not in breach the Code for Therapeutic Products.

Accordingly the Panel ruled to not uphold the complaint.


The Panel turned to advertisements C, D and E and noted that all three were
advertisements directed to healthcare practitioners. The Panel was particularly
mindful of the fact that because healthcare practitioners have expert and
professional knowledge in their relevant fields, there was a level of expectation that
they could disseminate scientific information and distinguish between information of
value and advertising hyperbole.
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                                                                                07/165




The Panel considered that the remaining three advertisements could be determined
by a two-step process. The first step related to the use of the phrase “Total Control”
but more particularly whether, in context, its use could be defined in accordance with
the Code. If the Panel concluded that it was defined in accordance with the Code
then it was appropriate to consider step two of the process and determine whether
the claim was valid in terms of the funding information. This referred to the use of
the statement that the advertised product [Seretide] was: “Fully Funded With Special
Authority…”.

In the Panel‟s view, step one required it to consider the meaning of the word “Total”
in the context of the phrase “Total Control” of asthma. Accordingly, the Panel
considered first, the normal meaning of the word. The Collins Dictionary stated that
the word “Total” meant complete or absolute. The Panel agreed that in the normal
sense of the word, the phrase would mean absolute or complete control of asthma
in 100% of patients. The Panel also considered the meaning of the word “Total” as
defined by the Bateman/Goal Study. The GOAL study examined whether guideline
defined asthma control could be achieved in 3416 patients with uncontrolled
asthma. On Seretide 41% of patients achieved total control and 71% achieved well
controlled asthma for periods of 7 our of 8 weeks after 12 months. Total control was
defined as experiencing none of the 7 listed symptoms for at least 7 out of 8 weeks.
The definitions of “control” were derived from the treatment goals of the Global
Initiative for Asthma/National institutes of Health guidelines.

Therefore in the Panel‟s view the real issue related to whether the definition of
“Total” in the context of the phrase “Total Control” of asthma. was sufficiently clear
to the reader and the target market, be they medical practitioners or members of the
public.


Advertisement C

The Panel referred to the advertisement and noted that the heading, in bold large
letters, urged medical practitioners: “UPGRADE YOUR ASTHMA PATIENTS TO
SERETIDE FOR TOTAL CONTROL”. The boxed caption stated: “Fully Funded With
Special Authority” and included reference to four different doses. The fine print
under the caption referred to various studies and information relating to the product.

The Panel also referred to Part B3-Requirement 4.i.(ii) of the Code and the two step
process it developed to determine this complaint. It noted the use of the words
“Total Control” and meaning gained from the Bateman/Goal study on which the
claim was based.

The Panel noted that 41% of patients, who satisfied the criteria for participating in
the study, achieved “Total Control” of their asthma. It acknowledged that medical
practitioners would understand the significance of this result particularly in light of
the conclusions reached in the Goal Study. In addition there was „fine print‟
reference to the Bateman study, which went on to further justify the use of the words
“Total Control”. However, although the significance of the phrase “Total Control” was
deemed acceptable, in context, the Panel was concerned with the type size, the
colour and the proximity of the explanation for the headline claim. In the Panel‟s
view, any justification of an absolute claim should be immediately obvious to the
reader both in type size, colour and contiguity. This is extremely important for
                                          34
                                                                               07/165




therapeutic advertising, which invokes a very high standard of social responsibility.
The Panel concluded that in this instance, and in all three respects, the
advertisement failed to comply. Accordingly the definition was not deemed
sufficiently clear to the reader.

Having determined that the advertisement failed to comply with Principle 2 and Part
B3 Requirement 4 of the Code for Therapeutic Products, the Panel did not consider
it necessary to consider part two of its two step process.

Accordingly the Panel ruled to uphold the complaint.


Advertisement D

The Panel observed that this advertisement was described as a flyer and designed
to wraparound the New Zealand Doctor magazine in which Advertisement C was
published. Of concern to the Complainant were the statements “Help your patients
aim to live symptom free” and the Advertiser‟s catch phrase “Upgrade your asthma
patients to Seretide for TOTAL CONTROL”.

The Panel referred to Part B3-Requirement 4.i.(ii) of the Code and the two step
process it developed to determine the complaint. In terms of the first statement,
“Help your patients aim to live symptom free”, the Panel was satisfied that it was
sufficiently qualified by the use of the words “help” and “aim” to preclude any
misunderstanding as to its meaning. In other words and in terms of the Code, a
medical practitioner would not be misled by the statement and as such, it was not in
breach of the Code.

The Panel also observed that the reference to the „Goal study‟, which was included
in the advertisement to explain and/or justify the absolute statement “Upgrade your
asthma patients to Seretide for TOTAL CONTROL”, appeared in small print at the
base of a different panel containing part of the statement, “Help your patients aim
…”. The Panel was again conscious of the type size, but more importantly it
observed the contiguity of the justification.

The Panel reiterated its view that any justification for a claim should be immediately
obvious to the reader both in type size and contiguity. It referred again to the
advertisement and concluded that although the type size of the reference to the
GOAL study was sufficient there was lack of contiguity. The statement "Upgrade
your asthma patients to Seretide for TOTAL CONTROL" was located on the right
hand side of the flyer and was immediately followed by an asterisk. The asterisk
referencing to the GOAL study was located on the left hand side of the flyer with the
result it was not readily observed by the casual reader. If the reference had been
immediately under the TOTAL CONTROL statement it would have had sufficient
contiguity. Accordingly, the Panel concluded that the claim was not sufficiently clear
to the reader and as such failed to satisfy the high standards required of therapeutic
advertising.

Having determined that the advertisement failed to comply with Principle 2 and Part
B3 Requirement 4 of the Code for Therapeutic Products, the Panel did not consider
it necessary to consider part two of its two step process.
                                          35
                                                                                07/165




Accordingly, the Panel ruled to uphold the complaint.


Advertisement E

The Panel referred to the advertisement and noted that the heading, in large letters
asked the question, “IS YOUR ASTHMA GOAL TOTAL CONTROL?” and then
provided the response CONSIDER SERETIDE. In clear print in the body of the
advertisement the Advertiser provided its justification for the use of the words “Total
Control” with an explanation of the Goal study. A boxed caption under the body of
the advertisement in small but clear print stated: “Fully Funded With Special
Authority”. It included references to various dosages of the product.

The Panel referred to Part B3-Requirement 4.i.(ii) of the Code and the two step
process it developed to determine the complaint. It also reiterated its view that any
justification for a claim should be immediately obvious to the reader both in type size
and contiguity. The Panel acknowledged at the outset that in this advertisement the
words “Total Control” were not part of a claim. It also concluded that the type size,
colour and contiguity of the explanation of the „Goal study‟ satisfied its previous
rulings. In other words the advertisement was clear and unambiguous to the reader
and it was not, nor was it likely to be, misleading or deceptive. Accordingly, the
Panel was of the view that in this respect the advertisement was not in breach of the
Therapeutic Code.

Having satisfied the first step of the process, the Panel turned to the second step.
Here the Panel was required to determine whether the claim was valid in terms of the
funding information. This referred to the use of the boxed statement, “Seretide is fully
funded with special authority” together with the lists of doses that were fully funded.
What the Panel did note however was that there was no reference at all to those
doses to which a charge applied.

Contrary to the Advertiser‟s submission, it was the Panel‟s view that the funding
statement could not be viewed in isolation of the advertisement as a whole. In
particular the Goal study, which was used by the Advertiser to justify and validate
the use of the words “Total Control”. In the Panel‟s view, each aspect of the
advertisement, the claim, the justification and the funding information, was integral
to the message the Advertiser was disseminating.

The Panel considered the results of the Goal study, particularly that 41% of patients
with uncontrolled asthma achieved “Total Control” on Seretide. It referred to the
Bateman study, which was noted in, but independent of the advertisements and
provided information on the doses required by patients to achieve “Total Control”. It
also considered the funding criteria for the various doses that were required to
achieve the “Total Control” claimed in the advertisement. The Panel concluded that
a number of people in the 41% of patients referred to in the Goal study, required
doses of Seretide that were outside the current funding criteria in New Zealand. In
other words, the funding information was incomplete. In the Panel‟s view, by
omitting to include the high end and low end doses of Seretide, which were not
funded, within the funding information in the advertisement, the claim that 41% of
patients achieved “Total Control” on what appeared to be “fully funded” doses of
Seretide was incorrect and misleading to the reader.
                                         36
                                                                              07/165




The Panel was of the opinion that the Code could have been satisfied if the funding
information included reference to non-funded dosages in such a way that the claim
“41% of patients with uncontrolled asthma achieved „Total Control‟ on Seretide” was
related to the product rather than the particular category of funding.

As a result, the Panel was of the view that the relationship between the words “Total
Control”, the funding information, the Goal study and the content of the Bateman
paper, created an ambiguity that was likely to mislead the reader. Therefore in the
Panel‟s view, this aspect of the advertisement failed to comply with Principle 2 and
Part B3 Requirement 4 of the Code for Therapeutic Products.

Accordingly the Panel ruled to uphold the complaint.

Decisions:

Advertisement A – Settled

Advertisement B – Not Upheld

Advertisement C – Upheld

Advertisement D – Upheld

Advertisement E – Upheld

				
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