Case Summary
AstraZeneca voluntarily admitted that, in response to a request for clarification about discounts, one of its dispensing account managers had sent an unapproved promotional email for Crestor (rosuvastatin) to a dispensing practice. The email contained promotional claims that were inaccurate, unbalanced and misleading.
AstraZeneca noted that the email was promotional but was not approved through review and certification by registered signatories and did not contain prescribing information.
The email contained the claim 'The start dose for ALL patients is 10mg …'. Although this was later qualified by the statement 'You can use 5mg in patients who can't tolerate a statin/the very elderly etc …', the claim was inaccurate, exaggerated and inconsistent with section 4.2 of the Crestor summary of product characteristics (SPC) which emphasised the recommendation of a 5mg start dose in certain patient groups. The email also contained the claims '85% to 90% of all patients should get to target on 10mg as it is so effective …' and 'Crestor is so well tolerated with so many fewer interactions than simva and atorva …' and 'is metabolised via the same pathway as prava making it much cleaner …' which were exaggerated and could not be substantiated. Two PowerPoint slides attached to the email showing Crestor data in the form of graphs although accurate, could be construed as promotion and had not been approved for such use and did not contain prescribing information.
The detailed response from AstraZeneca is given below.
The email from the dispensing account manager to the dispensary manager began by discussing potential discounts. The third paragraph read 'The start dose for ALL patients is 10mg as 10mg is equivalent to simva 80mg and atorva 40mg. 85% to 90% of all patients should get to target on 10mg as it is so effective. You can use 5mg in patients who can't tolerate a statin/the very elderly etc but it is the same price as 10mg and Crestor is so well tolerated with so many fewer interactions than simva and atorva (is metabolised via the same pathway as prava making it much cleaner) most use 10mg straight off'.
The Panel noted that the email discussed the efficacy and tolerability of Crestor. It did not contain prescribing information nor had it been certified. Breaches of the Code were ruled.
Section 4.2 of the Crestor SPC stated that the'recommended start dose is 5mg or 10mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions'. The 5mg dose was the recommended start dose in patients over 70 years, patients with moderate renal impairment and patients with predisposing factors to myopathy. The Panel considered that the claim 'The start dose for ALL patients is 10mg…' was misleading, incapable of substantiation, exaggerated and inconsistent with the SPC. Breaches of the Code were ruled.
The Panel considered that the claim '85% to 90% of all patients get to target on 10mg as it is so effective' was incapable of substantiation and exaggerated as acknowledged by AstraZeneca. Breaches of the Code were ruled.
The email featured a claim which compared the tolerability of Crestor with that of simvastatin and atorvastatin: 'Crestor is so well tolerated with so many fewer interactions than simva and atorva (is metabolised via the same pathway as prava making it much cleaner) …'. The Panel considered that this claim was exaggerated and could not be substantiated as acknowledged by AstraZeneca. Breaches of the Code were ruled.
The Panel considered that the two PowerPoint slides attached to the email were promotional; they each contained graphs which favourably compared Crestor with other statins and one featured the product logo. The Panel noted AstraZeneca's acknowledgement that they had not been approved for promotional use and did not contain prescribing information. Breaches of the Code were ruled. The Panel considered that overall high standards had not been maintained. A breach of the Code was ruled.
The Panel did not consider that the circumstances warranted a breach of Clause 2 which indicated particular censure and was reserved for such use
CASE AUTH/2206/2/09 VOLUNTARY ADMISSION BY ASTRAZENECA
Crestor email
AstraZeneca voluntarily admitted that, in response to a request for clarification about discounts, one of its dispensing account managers had sent an unapproved promotional email for Crestor (rosuvastatin) to a dispensing practice. The email contained promotional claims that were inaccurate, unbalanced and misleading.
AstraZeneca noted that the email was promotional but was not approved through review and certification by registered signatories and did not contain prescribing information.
The email contained the claim ‘The start dose for ALL patients is 10mg …’. Although this was later qualified by the statement ‘You can use 5mg in patients who can’t tolerate a statin/the very elderly etc …’, the claim was inaccurate, exaggerated and inconsistent with section 4.2 of the Crestor summary of product characteristics (SPC) which emphasised the recommendation of a 5mg start dose in certain patient groups. The email also contained the claims ‘85% to 90% of all patients should get to target on 10mg as it is so effective …’ and ‘Crestor is so well tolerated with so many fewer interactions than simva and atorva …’ and ‘is metabolised via the same pathway as prava making it much cleaner …’ which were exaggerated and could not be substantiated. Two PowerPoint slides attached to the email showing Crestor data in the form of graphs although accurate, could be construed as promotion and had not been approved for such use and did not contain prescribing information.
The detailed response from AstraZeneca is given below.
The email from the dispensing account manager to the dispensary manager began by discussing potential discounts. The third paragraph read ‘The start dose for ALL patients is 10mg as 10mg is equivalent to simva 80mg and atorva 40mg. 85% to 90% of all patients should get to target on 10mg as it is so effective. You can use 5mg in patients who can’t tolerate a statin/the very elderly etc but it is the same price as 10mg and Crestor is so well tolerated with so many fewer interactions than simva and atorva (is metabolised via the same pathway as prava making it much cleaner) most use 10mg straight off’.
The Panel noted that the email discussed the efficacy and tolerability of Crestor. It did not contain prescribing information nor had it been certified. Breaches of the Code were ruled.
Section 4.2 of the Crestor SPC stated that the ‘recommended start dose is 5mg or 10mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient’s cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions’. The 5mg dose was the recommended start dose in patients over 70 years, patients with moderate renal impairment and patients with predisposing factors to myopathy. The Panel considered that the claim ‘The start dose for ALL patients is 10mg…’ was misleading, incapable of substantiation, exaggerated and inconsistent with the SPC. Breaches of the Code were ruled.
The Panel considered that the claim ‘85% to 90% of all patients get to target on 10mg as it is so effective’ was incapable of substantiation and exaggerated as acknowledged by AstraZeneca. Breaches of the Code were ruled.
The email featured a claim which compared the tolerability of Crestor with that of simvastatin and atorvastatin: ‘Crestor is so well tolerated with so many fewer interactions than simva and atorva (is metabolised via the same pathway as prava making it much cleaner) …’. The Panel considered that this claim was exaggerated and could not be substantiated as acknowledged by AstraZeneca. Breaches of the Code were ruled.
The Panel considered that the two PowerPoint slides attached to the email were promotional; they each contained graphs which favourably compared Crestor with other statins and one featured the product logo. The Panel noted AstraZeneca’s acknowledgement that they had not been approved for promotional use and did not contain prescribing information. Breaches of the Code were ruled.
The Panel considered that overall high standards had not been maintained. A breach of the Code was ruled. The Panel did not consider that the circumstances warranted a breach of Clause 2 which indicated particular censure and was reserved for such use.
AstraZeneca voluntarily admitted that one of its dispensing account managers had sent an unapproved promotional email for Crestor (rosuvastatin) to a health professional. The email contained promotional claims that were inaccurate, unbalanced and misleading.
COMPLAINT
AstraZeneca explained that the email was sent in response to an enquiry from a dispensary manager of a dispensing practice on 13 November. The dispensary manager wanted clarification on discounts offered on 10mg and 20mg rosuvastatin and also asked, ‘Do you swap simvastatin 40mg to rosuvastatin 20mg?’
Whilst there had been no external complaints in relation to this email, fortunately another employee in the same team brought this matter to the attention of their line manager who referred the correspondence to the compliance department.
Following this notification, corrective correspondence was sent to the practice dispensary manager to clarify all issues with an offer for a faceto-face follow up to address any potential misunderstandings. AstraZeneca submitted that, following a full internal investigation, a comprehensive range of proactive activities had been completed with the individual concerned. The company considered that this was an isolated incident, but nevertheless had taken the opportunity to schedule other activities as part of ongoing compliance training.
AstraZeneca outlined the corrective measures taken.
Internal measures:
- The individual concerned had undergone one-toone retraining on the Code and company policies with specific focus on the requirements around email communication. Appropriate action in accordance with company policy was taken against the individual to reflect this serious mistake. Although this was an isolated incident, all dispensing account managers, sales management and representatives had been reminded about the Code requirements for emails. By the end of February 2009 they would also receive an update to their Field Guide which was a hard copy folder that all representatives carried containing company policies and guidance on compliant conduct. Face-to-face Code and role specific retraining would take place for all dispensing account managers in February 2009.
External Measures:
- AstraZeneca wrote to the practice concerned noting the errors and providing corrected information. A follow-up meeting and/or further information was offered if required. To date no request had been received from the practice. In addition AstraZeneca self reported to the PMCPA.
The email in question:
- Was promotional in nature but was not approved through review and certification by registered signatories.
- Contained the claim ‘The start dose for ALL patients is 10mg …’. Although this was later qualified by the statement ‘You can use 5mg in patients who can’t tolerate a statin/the very elderly etc …’, the claim was inaccurate, exaggerated and inconsistent with section 4.2 of the Crestor summary of product characteristics (SPC) which emphasised the recommendation of a 5mg start dose in certain patient groups.
- Contained the claim ‘85% to 90% of all patients should get to target on 10mg as it is so effective …’. The claim was not capable of substantiation and was exaggerated.
- Contained the claim ‘Crestor is so well tolerated with so many fewer interactions than simva and atorva …’ and ‘is metabolised via the same pathway as prava making it much cleaner …’. These were exaggerated safety claims that could not be substantiated.
- Did not contain prescribing information.
- Contained a PowerPoint attachment consisting of 2 slides showing Crestor data in the form of graphs. Although there were no promotional claims and the data was accurate, the slides could be construed as promotion and had not been approved for such use and they did not contain prescribing information.
AstraZeneca submitted that the following points should be taken into account.
- The dispensing account manager had confirmed that this was an isolated incident and recognised that in her desire to reply quickly (within an hour of the request) and helpfully, she had exceeded her authority. The lapse of judgement was probably compounded by the fact that the dispensary manager and the dispensing account manager had a very close family connection. However, the email was sent in a business context and so the Code applied.
- In April 2008 the dispensing account manager passed an annual test on the updated company policy relating to sales and marketing practices which included the requirements of the Code. The dispensing account manager also passed a test on the AstraZeneca global code of conduct which required all employees to adhere to all relevant company and external codes.
- There had been no external complaint in relation to the email and any possibility for external misunderstanding had been minimised by the appropriate action taken.
This investigation and outcome was tabled at AstraZeneca’s internal governance meeting on 27 January 2009. A range of additional actions were discussed and it was agreed that a further meeting should be convened as a matter of urgency to agree a clear corrective action plan. As a result, further additional requirements stipulated that reassurance must be provided that the whole dispensing account manager team, as well as the wider field force, continued to comply with the Code to ensure that similar incidents should not occur again. AstraZeneca undertook every measure to comply with the Code in both letter and spirit and considered that any breach was an extremely serious matter. The governance committee would retain direct oversight of the actions to ensure they were implemented effectively and diligently.
AstraZeneca submitted that this incident was more than regrettable and all actions were being undertaken to ensure it did not happen again.
Paragraph 5.4 of the 2008 Constitution and Procedure provided that the Director should treat a voluntary admission as a complaint if it related to a potentially serious breach of the Code or if the company failed to take appropriate action to address the matter. Issuing uncertified material and promoting medicines by email were serious matters and the admission was accordingly treated as a complaint.
When writing to AstraZeneca the Authority asked it to respond in relation to the requirements of Clauses 2, 3.2, 4.1, 7.2, 7.4, 7.9, 7.10, 9.1 and 14.1 of the Code.
RESPONSE
In addition to its comments above AstraZeneca submitted that it took the Code extremely seriously and undertook every effort to comply with it in both letter and spirit. To this end, the company had robust and wide-ranging measures to ensure compliance with the Code through training, monitoring, approval and auditing processes. In addition, AstraZeneca strongly encouraged all employees to report any potential breaches of the Code to their manager or to the compliance functions. The company had dedicated independent telephone lines and a website to further facilitate such reporting.
It was this culture of openness and express commitment to the Code which gave an AstraZeneca employee the confidence to raise this matter internally and which the company had duly referred to the PMCPA. As part of this process, AstraZeneca accepted that the email in question was in breach of Clauses 3.2, 4.1, 7.2, 7.4, 7.9, 7.10 and 14.1.
As part of this process of self-reporting, a thorough review of the training processes in place for the individual who sent the email showed that they:
- passed the ABPI examination for representatives in July 1998
- underwent an AstraZeneca ‘Initial Training Course’ and validation (which included training on the Code) in January 2000
- passed an annual test on the company’s updated policy relating to sales and marketing practices which included the Code, in April 2008
- passed a test on the AstraZeneca global code of conduct in August 2008
Despite the training provided by AstraZeneca, the dispensing account manager concerned sent an email that was in breach of the clauses referred to above. This was due to a genuine, though isolated, lapse of judgement probably compounded by the fact that the dispensary manager (to whom the email was sent) and the dispensing account manager had a very close family connection.
AstraZeneca did not believe that this matter warranted a ruling of breach of either Clause 9.1 or Clause 2. In relation to Clause 9.1, the individual concerned had received prior training from AstraZeneca and robust and rapid internal and external corrective actions were taken by AstraZeneca when it knew of the email. In addition, the email was not an unsolicited approach but was sent in response to a request by the dispensing practice manager, nor had the email caused any offence and the type, style and method of the communication was not such as to be considered unsuitable or distasteful.
In relation to a breach of Clause 2, it was important to note that this isolated email was only sent to a single recipient and that there had been no external complaint about it. These facts, together with the external corrective action taken meant that there was no question that the reputation of the industry had been damaged nor that confidence in the industry been reduced.
AstraZeneca provided an anonymised version of the original email request from the dispensary manager.
AstraZeneca stated that it took the Code extremely seriously and the governance committee (composed principally of the directors) would retain direct oversight of the corrective actions to ensure there was no recurrence.
PANEL RULING
The email from the dispensing account manager to the dispensary manager began by discussing potential discounts. The third paragraph read ‘The start dose for ALL patients is 10mg as 10mg is equivalent to simva 80mg and atorva 40mg. 85% to 90% of all patients should get to target on 10mg as it is so effective. You can use 5mg in patients who can’t tolerate a statin/the very elderly etc but it is the same price as 10mg and Crestor is so well tolerated with so many fewer interactions than simva and atorva (is metabolised via the same pathway as prava making it much cleaner) most use 10mg straight off’.
The Panel noted that the email was sent in response to an enquiry about discounts for Crestor. It was not clear whether the enquiry was solicited or not. The Panel considered that in any case the email in question could not take the benefit of the exemption in Clause 1.2 to the definition of promotion whereby replies to unsolicited enquiries were exempt from the definition of promotion if, inter alia, they related solely to the subject matter of the enquiry and were not promotional in nature. The Panel noted that the email discussed the efficacy and tolerability of Crestor. It did not contain prescribing information nor had it been certified as required by Clause 14.1. Breaches of Clauses 4.1 and 14.1 were ruled.
Section 4.2 of the Crestor SPC stated that the ‘recommended start dose is 5mg or 10mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient’s cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions’. The 5mg dose was the recommended start dose in patients over 70 years, patients with moderate renal impairment and patients with predisposing factors to myopathy. The Panel considered that the claim ‘The start dose for ALL patients is 10mg…’ was misleading, incapable of substantiation, exaggerated and inconsistent with the SPC. Breaches of Clauses 3.2, 7.2, 7.4 and 7.10 were ruled.
The Panel considered that the claim ‘85% to 90% of all patients get to target on 10mg as it is so effective’ was incapable of substantiation and exaggerated as acknowledged by AstraZeneca. Breaches of Clauses 7.4 and 7.10 were ruled.
The email featured a claim which compared the tolerability of Crestor with that of simvastatin and atorvastatin: ‘Crestor is so well tolerated with so many fewer interactions than simva and atorva (is metabolised via the same pathway as prava making it much cleaner) …’. The Panel considered that this claim was exaggerated and could not be substantiated as acknowledged by AstraZeneca. Breaches of Clauses 7.4, 7.9 and 7.10 were ruled.
The Panel noted the email attachment comprised two PowerPoint slides for Crestor. The Panel did not accept that the slides did not contain promotional claims as submitted by AstraZeneca; they each contained graphs which favourably compared
Crestor with other statins. One of the slides featured the product logo. The Panel noted AstraZeneca’s acknowledgement that they had not been approved for promotional use and did not contain prescribing information. Breaches of Clauses 14.1 and 4.1 were ruled.
The Panel considered that overall high standards had not been maintained. A breach of Clause 9.1 was ruled. The Panel did not consider that the circumstances warranted a breach of Clause 2 which indicated particular censure and was reserved for such use. No breach of Clause 2 was ruled.
Complaint received 11 February 2009
Case completed 17 March 2009
