Minutes of the code of conduct committee meeting

Reason for the decision pertaining to
complaint 1084 – Lipitor Promotional Materials
June 2012 Code of Conduct Meeting

Subject Company: Pfizer Australia
Complainant: Dr Ken Harvey

Product: Lipitor
Complaint
Dr Harvey alleged that advertisements placed in general media publications directly promoted
Lipitor to the general public and therefore were in breach of Section 12.3 of the Code of
Conduct.
Sections of the Code
The advertisements were alleged to be in breach of the following Sections of Edition 16 of the
Code:
 12.3 Promotion to the general public
Response
Pfizer responded that it had released the Community Service Announcements (CSAs) after
receiving an unprecedented number of calls from consumers regarding the availability of Lipitor.
The decision to publish the announcements was not taken lightly and Pfizer acknowledged that
it was an unusual and inevitably controversial action.
Pfizer noted that its primary responsibility in releasing in the CSAs was to address the
misinformation and to allow patients to make a proper, informed treatment choice.
Code Committee decision
The Committee determined by majority decision that the activity was in breach of Section 12.3
of the Code of Conduct.
Sanction
 Cease using the claim that was found in breach of the Code in any activities directed at the general public  Pay a fine of $50,000
Consideration of the complaint
The Committee considered that the central question concerning this complaint was whether the
published communication to the general public was promoting Pfizer's product Lipitor.
The Committee discussed whether the activity could be considered an advertisement promoting
a particular prescription medicine as alleged by the complainant, or an educational activity as
argued by the subject company. The Committee accepted that the piece did contain some
element of educational information that was relevant to the target audience. The Committee
Minutes of Code of Conduct Committee Meeting – 18 June 2012 referred to the Glossary in the Code of Conduct (Edition 16, page 158) which defines ‘promote' in the context of an advertisement as "all informational and persuasive activities, the purpose, actual or likely effect of which is to induce or discourage the purchase, sale, supply and/or use of therapeutic products". The Committee also reviewed the definition of an ‘advertisement', which adopts the definition from the Therapeutic Goods Act 1989 (Cwth), meaning "any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods". It was noted that this definition should be interpreted from the perspective of how a reader of the information would interpret the communication. The Committee agreed by majority that the intent of the communication subject to complaint was to encourage patients who have been prescribed Lipitor to continue to ask for the Lipitor brand of atorvastatin. This is consistent with the definition of an ‘advertisement'. A minority of Committee members disagreed with this opinion. These members considered that the activity was intended to educate patients in response to misinformation about the availability of Lipitor and therefore it was not an advertisement as described by the Code. Having agreed by majority that the communication issued by Pfizer concerning Lipitor was an advertisement, the Committee then debated at length whether the statement "A message to the more than 1 million patients prescribed Lipitor®" was promotional. The Committee referred to the definition of ‘promotion, promotional and promotional claim' in the Glossary of the Code of Conduct (Edition 16, page 158). It noted that a statement is promotional if it "conveys the positive attributes of a product which extend beyond a simple non-qualitative or quantitative description of the therapeutic category or approved indication for the purpose of encouraging the usage of that product". Some Committee Members considered that the heading statement was intended to create an action by patients who are taking Lipitor to continue to ask for that product. Committee Members considered that in the face of generic competitors entering the market, Pfizer's communication to consumers was intended to encourage patients to ask for the Lipitor brand rather than another brand of atorvastatin. Some members of the Committee also considered that the reference to the "more than 1 million patients prescribed Lipitor" may also be interpreted as suggesting to patients who are not taking Lipitor that it is preferred by a large number of patients and perhaps they should ask for it. The Committee considered that the communication went further than simply telling patients that the suggestion that Lipitor had been discontinued or was not available was incorrect. The Committee agreed by majority decision that the heading statement was promotional and therefore was in breach of the Section 12.3 of the Code of Conduct. The Committee noted that generic atorvastatin products were recently listed on the PBS. Evidence supplied by Pfizer in support of its rationale for the communication noted that there had been a significant increase in the number of calls to the Pfizer Medical Information department questioning the unavailability of Lipitor. Pfizer reported that the number of calls was 3 times greater than previously received on a regular monthly basis relating to Lipitor. Of these calls, 25% of patients had presented a prescription for Lipitor to a pharmacist and were given false information including that the product was no longer available or had been discontinued; Lipitor had changed its name to Atorvastatin-Pfizer; or that there are supply issues from the manufacturer and there is no stock available. Pfizer had also provided photographic evidence of community pharmacies' displays advising customers that Lipitor was no longer available, had changed packaging to an alternative brand or that another product was the "new" Lipitor. In its Minutes of Code of Conduct Committee Meeting – 18 June 2012 response, Pfizer argued that the unprecedented actions of community pharmacies in supplying
false and misleading information to patients ultimately led it to issue the advertisement.
The Committee agreed that the activities of some community pharmacies shown in the
response were egregious; however it did not agree, by majority, that this justified undertaking
the activity subject to this complaint directed to the general public. The Committee noted that
the prohibition on promotion of prescription medicines to the general public reflects the
Therapeutic Goods Legislation, which is absolute and does not allow for any justification for this
conduct, whether in response to an unprecedented situation or not. The Committee, however,
agreed that Pfizer had a right to correct the misinformation being communicated about its
product, but any communication to the general public should not have included a promotional
claim. The Committee was very concerned at the conduct of some community pharmacists in
incorrectly informing patients about the lack of availability of Lipitor and representing other
products as replacing Lipitor, however there were alternative solutions available to Pfizer to
correct this misinformation.
Sanction
The Committee reviewed the definitions of severe, moderate and minor breaches of the Code.
It agreed by majority decision that the activity constituted a minor breach of the Code of
Conduct because the conduct did not have any safety implications for patients and would not
have a major effect on how the medical profession will prescribe the product.
The Committee agreed by majority decision that Pfizer should:
 Cease using the claim "A message to the more than 1 million patients prescribed Lipitor" in any activities directed at the general public  Pay a fine of $50,000 The Committee agreed by unanimous decision that corrective action was not appropriate in this instance as it would have the potential to compound the offence of promoting the product to consumers. When determining the sanction, the Committee considered the extremely widespread distribution of the advertisement, being in a wide variety of print media as well as radio segments across a range of stations. It also considered the inability for corrective action and that the activity was determined to be promotion of a prescription medicine to the general public. However, this view was balanced by the single statement being found in breach and the conduct of community pharmacies that had precipitated the activity. Minutes of Code of Conduct Committee Meeting – 18 June 2012

Source: http://www.medreach.com.au/wp-content/uploads/2012/07/20120702-RFD-CoCC-1084.pdf