Corrective statements

Corrective statements issued by companies can be found below.

AUTH/3010/1/18 - Daiichi-Sankyo

‘Corrective statement

Between July 2016 and 20 August 2018, a Lixiana (edoxaban) Initiation Information Guide (ref EDX/16/0171) and/or a Lixiana Practical Guide (ref EDX/15/0091(4)) might have been provided to you by Daiichi-Sankyo UK Limited.
Section 4.4 of the Lixiana SPC, Special warnings and precautions for use, states under the sub heading ‘Renal function in [nonvalvular atrial fibrillation] NVAF’:

‘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).’

Daiichi-Sankyo apologises for the fact that the items at issue failed to include this warning other than in the prescribing information. Daiichi-Sankyo takes its responsibilities under the ABPI Code of Practice for the Pharmaceutical Industry and patient safety seriously and is disappointed at these failings. As an organisation we will take all possible steps to ensure that this is not repeated.

Following a complaint under the ABPI Code of Practice for the Pharmaceutical Industry, the Code of Practice Appeal Board ruled that the omission rendered the materials misleading and therefore the materials did not encourage the rational use of the medicine. The Appeal Board also ruled that Daiichi-Sankyo had failed to maintain high standards and had brought discredit upon and reduced confidence in the pharmaceutical industry. As a result of the above Daiichi-Sankyo has been required to issue this corrective statement and to refer to the published report for the case which contains full details. In addition Daiichi-Sankyo has been required to recover the material at issue. If you still have the material at issue please return it in the attached prepaid envelope as soon as possible.

Details of this case (Case AUTH/3010/1/18) are also available on the PMCPA website (www.pmcpa.org.uk).’

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 13^th 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 Richter

‘Corrective statement

Between July and November 2016, a patient support leaflet for Esmya (ulipristal acetate) (ref UK/ESM5/0416/0033) produced by Gedeon Richter (UK) Ltd was circulated. Esmya is indicated for the pre-operative or intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

You are being sent this corrective statement because you may have received the Esmya patient support leaflets to pass on to your patients when you prescribed them Esmya.

Following a complaint under the ABPI Code of Practice for the Pharmaceutical Industry, the Code of Practice Panel ruled that the patient support leaflet was inaccurate and misleading in that it only told the woman that she should not take oral contraceptives whilst on Esmya whereas she should have been told not to use hormonal contraceptives whilst taking Esmya. The Panel ruled that Gedeon Richter had failed to maintain high standards and had brought discredit upon and reduced confidence in the pharmaceutical industry. As a result of the above and concerns about patient safety, the Code of Practice Appeal Board has required Gedeon Richter to issue this corrective statement and to circulate a copy of the published report for the case which contains full details. This is enclosed.

If you have any remaining copies of the above patient support leaflet please dispose of them.

In addition, where relevant, please draw this issue to the attention of any GP to whom you might have referred patients for repeat prescriptions of Esmya.

Details of this case (Case AUTH/2885/11/16) are also available on the PMCPA website (www.pmcpa.org.uk).’

On 30 March, 2017 Gedeon Richter sent copies of the case report and the company's corrective statement to relevant hospital doctors.

AUTH/2825/3/16 and AUTH/2826/3/16 - Janssen-Cilag v Boehringer Ingelheim and Lilly

‘Corrective statement

Between 12 January and 20 April 2016, a letter addressed to ‘Dear UK Healthcare Professional’ (ref UK/EMP/00241) was provided to you by a sales representative on behalf of Boehringer Ingelheim Ltd and Eli Lilly and Company Ltd (the Alliance). The letter was stapled to a copy of Zinman et al (2015), ‘Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes’ (the EMPA-REG study) and a 1 sided A4 sheet which gave the prescribing information for Jardiance (empagliflozin). Following a complaint under the ABPI Code of Practice for the Pharmaceutical Industry, the Code of Practice Appeal Board ruled that the letter was inconsistent with the Jardiance summary of product characteristics and constituted disguised promotion. The Appeal Board also ruled that the Alliance had failed to maintain high standards and had brought discredit upon and reduced confidence in the pharmaceutical industry. As a result of the above the Alliance has been required to issue this corrective statement and to circulate a copy of the published report for the case which contains full details. This is enclosed. In addition the Alliance has been required to recover the material at issue. If you still have the material at issue please return it in the attached prepaid envelope as soon as possible. If you no longer have the material at issue, please confirm this by completing the attached reply slip and return in the attached envelope.

Details of these cases (Cases AUTH/2825/3/16 and AUTH/2826/3/16) are also available on the PMCPA website (www.pmcpa.org.uk).’

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On 29 July 2016, the Alliance sent the company's corrective statement to recipients of the ‘Dear UK Healthcare Professional’ at issue.

Case AUTH/2780/7/15 - Anonymous, non-contactable employee v Astellas

'Corrective Statement

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).'

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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.

AUTH/2793/9/15 - Clinical pharmacist v AstraZeneca

Corrective statement

Dear Healthcare Professional,

Corrective Statement

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.

Best regards,

* * * * * *

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/2780/7/15 - Anonymous, non-contactable employee v Astellas

Corrective statement

Astellas Pharma Europe Ltd was required to provide UK delegates who attended its meeting on 27/28 February 2014 with a corrective statement. The meeting (Case AUTH/2747/1/15) was ruled in breach of the ABPI Code of Practice for the Pharmaceutical Industry and the corrective statement was sent on 1 July 2015.

Following a second complaint (Case AUTH/2780/7/15), the Code of Practice Panel ruled that Astellas Pharma Europe and Astellas UK had provided the Panel and the Appeal Board with false and incomplete information regarding the selection criteria for attendees at the meeting. High standards had not been maintained and this had brought discredit upon, and reduced confidence in, the pharmaceutical industry. As a result Astellas Pharma Europe and Astellas UK have been required to issue this further corrective statement and to circulate a copy of the published report for Case AUTH/2780/7/15 which contains full details and is enclosed.

Details of these cases (Case AUTH/2747/1/15 and Case AUTH/2780/7/15) are also available on the PMCPA website (www.pmcpa.org.uk).

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Astellas Pharma 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 on 4 January 2016.

Date posted 7 January 2016

Case AUTH/2783/7/15 - The Daily Telegraph/Director v Stirling Anglian - Arrangements for a meeting

Corrective statement

On 2/3 July, you attended a meeting organised by Stirling Anglian Pharmaceuticals Ltd, held in Baden-Baden. The meeting was described as an “Advisory Board”.

An article in The Daily Telegraph on 25 July raised concerns about the excessive hospitality provided at the meeting and the matter was taken up by The Prescription Medicines Code of Practice Authority as a complaint under the ABPI Code of Practice for the Pharmaceutical Industry (Case AUTH/2783/7/15). The Code of Practice Panel ruled that the arrangements did not meet the criteria for an advisory board and that UK health professionals had thus been paid to attend a promotional meeting. The Panel also considered that the meeting was an inducement to recommend Stirling Anglian’s medicines and that the hospitality provided was not appropriate, was out of proportion to the occasion and that the costs exceeded the level that recipients would normally adopt if paying for themselves. The Panel considered that Stirling Anglian had failed to uphold high standards and had brought discredit upon, and reduced confidence in, the pharmaceutical industry. The Panel considered that its concerns warranted further consideration and thus reported Stirling Anglian to the Code of Practice Appeal Board. The Appeal Board was extremely concerned that health professionals had attended the meeting on the false understanding that it was a genuine advisory board. The Appeal Board required Stirling Anglian to send you this corrective statement and a copy of the published report for the case which contains full details. This is enclosed.

Details of this case (Case AUTH/2783/7/15) are also available on the PMCPA website (www.pmcpa.org.uk).

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Stirling Anglian sent copies of the case report and the company's corrective statement to all UK delegates at the meeting. The materials were sent on 16 December 2015.

Date posted 16 December 2015

Case AUTH/2747/1/15 – Anonymous health professional v Astellas Pharma Europe - Arrangements for a meeting

Corrective statement

On 27/28 February 2014, Astellas Pharma Europe Ltd held a pan-european meeting which it described as an “Uro-oncology Advisory Board”. I am writing to you because you were a UK delegate at that meeting.

Following a complaint under the ABPI Code of Practice for the Pharmaceutical Industry, the Code of Practice Panel ruled that the arrangements did not meet the criteria for an advisory board and that UK health professionals had received payment to attend the meeting, which promoted Xtandi for an unlicensed indication. The Panel also ruled that Astellas Europe had failed to uphold high standards and brought discredit upon and reduced confidence in the pharmaceutical industry. As a result of the above Astellas Pharma Europe has been required 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/2747/1/15) are also available on the PMCPA website (www.pmcpa.org.uk).

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Astellas Pharma Europe sent copies of the case report and the company's corrective statement to all UK attendees at the meeting. The materials were sent on 1 July 2015.

Date posted 1 July 2015

Case AUTH/2721/7/14 - Shire v Genzyme - Material For An Advisory Group

Corrective statement

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