Corrective statements issued by companies can be found below.
‘A trend towards decreasing efficacy with increasing creatinine clearance was observed for edoxaban compared to well-managed warfarin (see section 5.1). Therefore, edoxaban should only be used in patients with NVAF and high creatinine clearance after a careful evaluation of the individual thromboembolic and bleeding risk. Assessment of renal function: CrCL should be monitored at the beginning of the treatment in all patients and afterwards when clinically indicated (see section 4.2).’
On 14 December Daiichi-Sankyo sent the following Corrective Statement to recipients of the material at issue and relevant UK prescribers.
Case AUTH/2971/8/17 - Thame 'Corrective statement
Between March and August 2017 Syri Ltd trading as Thame Laboratories sent a letter headed 'RE: Thamicarb, Sodium bicarbonate 1mmol/ml oral solution [PL 39307/0005]' about the prescription of Sodibic oral solution (sodium bicarbonate) as a food supplement instead of Thamicarb oral solution, marketed by Thame
You are being sent this corrective statement because you received this letter or a similar letter.
Following a complaint under the ABPI Code of Practice for the Pharmaceutical Industry, the Code of Practice Panel considered that the letter in question misleadingly stated that it was specifically required by the MHRA and that the MHRA had formally requested Thame to identify practices prescribing food supplements. The Panel noted the particular weight that would be attached by recipients to any reference to the MHRA.
The Panel considered that the letter implied that all patients on sodium bicarbonate oral solution could be switched to Thamicarb which was not so. The misleading implication that patients could be switched without any consideration of their clinical circumstances might potentially prejudice patient safety.
The letter did not state Thamicarb's licensed indication and that it could not be used with all patients that sodium bicarbonate oral solutions were prescribed for. The implication was misleading and was not capable of substantiation which also meant that the promotion of Thamicarb was inconsistent with the terms of its summary of product characteristics.
Use of the phrase 'vigorously prosecute' and the word 'non compliance' misleadingly implied that the use of a food supplement in preference to the unlicensed use of a licenced medicine was illegal. In addition the content of the letter disparaged the professional opinion of the health professionals who would be very concerned by the misleading implication that his/her prescribing decision was potentially illegal. The tone of the letter could be seen as threatening. Thame had failed to maintain high standards and it had brought discredit upon, and reduced confidence in, the pharmaceutical industry.
The Code of Practice Appeal Board required Thame Laboratories to issue this corrective statement and to circulate a copy of the published report for the case (Case AUTH/2971/8/17) which contains full details. This is enclosed.
Details of this case (Case AUTH/2971/8/17) are also available on the PMCPA website (www.pmcpa.org.uk).'
On 11 June 2018, Thame laboratories sent the following corrective statement to recipients of the letter at issue.
Case AUTH/2979/9/17 - PharmaMar 'Corrective statement
Between March and October 2017, the 'British Sarcoma Group 13th Annual Conference, 1st - 2nd March 2017 – Meeting Highlights' newsletter was available. The newsletter mentioned Yondelis (trabectedin) which was marketed by PharmaMar Ltd.
You are being sent this corrective statement because you received or might have received the newsletter.
Following a complaint under the ABPI Code of Practice for the Pharmaceutical Industry, the Code of Practice Panel considered that the newsletter was the responsibility of PharmaMar and it promoted its medicine for an unlicensed use. The document was also disguised promotion and the disguised nature was compounded by the inclusion of the disclaimer that 'This newsletter had been funded by an unrestricted educational grant provided by PharmaMar S.A. PharmaMar S.A. had not been involved in the production review or distribution of this material' which was not an accurate description of the role of the company
The Code of Practice Panel ruled that PharmaMar had failed to maintain high standards and had brought discredit upon and reduced confidence in the pharmaceutical industry. As a result of the above governance concerns, the Panel reported PharmaMar to the Code of Practice Appeal Board which required PharmaMar to issue this corrective statement and to circulate a copy of the published report for the case which contains full details. This is enclosed.
Details of this case (Case AUTH/2979/9/17) are also available on the PMCPA website (www.pmcpa.org.uk).'
On 9 April 2018, BSG sent the following corrective statement on behalf of PharmaMar to all attendees to the BSG conference and its organisers.
CASE AUTH/2885/11/16 - Gedeon
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