Corrective statements issued by companies can be found below.
Case AUTH/2780/7/15 - Anonymous, non-contactable employee v Astellas
Astellas Pharma Europe and Astellas UK have already sent corrective statements with regard to the meeting you attended in Milan on 27/28 February 2014.
Following a complaint under the ABPI Code of Practice for the Pharmaceutical Industry (Case AUTH/2747/1/15) breaches of the Code were ruled and the Code of Practice Panel reported Astellas Pharma Europe to the Code of Practice Appeal Board which required the company to issue a corrective statement. This was sent to you on 1 July 2015.
A subsequent complaint (Case AUTH/2780/7/15) revealed that the information provided in Case AUTH/2747/1/15 about the selection criteria for attendees at the meeting had been false and incomplete. The Panel reported Astellas Pharma Europe and Astellas UK to the Appeal Board which required a further corrective statement to be issued. This was sent to you on 4 January 2016.
Following the provision of further information from Astellas Pharma Europe which showed the extent to which the Panel and the Appeal Board had been misled and the seniority of the personnel involved, the Panel again reported Astellas Pharma Europe and Astellas UK to the Appeal Board. As a result Astellas Pharma Europe and Astellas UK have been required as part of a number of sanctions to issue another corrective statement and to circulate a copy of the updated report for Case AUTH/2780/7/15 which contains full details.
Details of these cases (Case AUTH/2747/1/15 and Case AUTH/2780/7/15) which include details of the subsequent suspension of Astellas UK from membership of the ABPI are also available on the PMCPA website (www.pmcpa.org.uk).'
Astellas Europe and Astellas UK sent copies of the case report and the company's corrective statement to all UK attendees at the meeting. The materials were sent in on 28 June 2016.
Dear Healthcare Professional,
Case AUTH/2793/9/15: Identifying patients suitable for Forxiga treatment
I am writing to you as I understand that your Practice uses the EMIS Web Clinical System.
AstraZeneca produced a leavepiece entitled '9 step guide to identify your uncontrolled and overweight patients with type 2 diabetes (T2D) who may be suitable for treatment with dapagliflozin EMIS Web Instructions' (ref 716.131.011). AstraZeneca markets Forxiga®▼ (dapagliflozin) which is indicated to improve glycaemic control in certain type 2 diabetic patients. You may have been provided with a copy of the leavepiece sometime between 19 May 2015 and 13 November 2015.
Following a complaint under the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry, the Code of Practice Panel ruled that the leavepiece was misleading, it was inconsistent with the Forxiga summary of product characteristics as following the 9 step guide could lead to patients being identified as suitable for Forxiga treatment based solely on their weight and not on HbA1c levels. Forxiga is not indicated for weight loss. The Panel considered that high standards had not been maintained. Subsequently the complainant brought to light that AstraZeneca had provided inaccurate information. As a result of this and other governance issues that subsequently emerged, the Panel reported AstraZeneca to the Code of Practice Appeal Board. The Appeal Board was concerned that use of the leavepiece might lead to the inappropriate prescription of Forxiga, and it considered that it was important that recipients of the leavepiece should be made aware of this. As a result AstraZeneca has been required to issue this corrective statement and to refer to the published report for the case which contains full details.
AstraZeneca takes its responsibilities under the ABPI Code seriously and is disappointed at these failings. As an organisation we will take all steps needed to ensure this is not repeated.
* * * * * *
On 15 June 2016, AstraZeneca sent the company's corrective statement to recipients of the leavepiece at issue.
Date posted 15 June 2016
Case AUTH/2783/7/15 - The Daily Telegraph/Director v Stirling Anglian - Arrangements for a meeting
Case AUTH/2721/7/14 - Shire v Genzyme - Material For An Advisory Group
On 26 February 2014, Genzyme Therapeutics Limited presented information about the use of Fabrazyme (agalsidase beta) in Fabry’s Disease to a meeting of the Lysosomal Storage Disorders Expert Advisory Group (LSDEAG). I am writing to you because you were at that meeting and/or received papers provided by Genzyme for pre-circulation.
Following a complaint by Shire Pharmaceuticals Limited under the ABPI Code of Practice for the Pharmaceutical Industry, the Code of Practice Appeal Board ruled that Genzyme’s material was, inter alia, inaccurate, unbalanced and misleading. Particular concerns were raised about statements relating to the dose and cost of Fabrazyme vs Replagal (agalsidase alfa, marketed by Shire) and the description of the two as being ‘biosimilar’. Some statements were inconsistent with the Fabrazyme summary of product characteristics (SPC). The materials thus fell short of the quality standards expected from a pharmaceutical company.
As a result of the above, Genzyme has been required to circulate a copy of the published report for the case which contains full details and this is enclosed.
Details of this case (Case AUTH/2721/7/14) are available on the PMCPA website (www.pmcpa.org.uk).
Genzyme arranged for copies of the interim case report and the company's corrective statement to be emailed to those who had attended the advisory group meeting or who had received copies of Genzyme’s materials prior to the meeting. The materials were sent on 18 March 2015.
Date posted 7 April 2015