AUTH/3396/10/20 - Complainant v Daiichi-Sankyo

Out-of-date material

  • Received
    05 October 2020
  • Case number
  • Applicable Code year
  • Completed
    27 May 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    Complainant appeal

Case Summary

An anonymous Sanofi employee complained that material used by Daiichi-Sankyo to promote Nilemdo (bempedoic acid) was out-of-date with regard to the information given about Sanofi’s medicine Praluent (alirocumab). Nilemdo and Praluent were both indicated in certain adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet.

The complainant stated that he/she had complained in a personal capacity, although his/her knowledge of the material at issue was due to his/her job at Sanofi. The complainant stated that he/she was not representing Sanofi in this complaint and Sanofi was not aware of it at all.

It has previously been decided, following consideration by the then Code of Practice Committee and the ABPI Board of Management, that private complaints from pharmaceutical company employees had to be accepted. To avoid this becoming a means of circumventing the normal procedures for inter-company complaints, the employing company would be named in the report. The complainant was advised that if he/she wished to proceed with the complaint in his/her private capacity, Sanofi would be named in the report and Daiichi-Sankyo would be informed of his/her employment status. The complainant was given an opportunity to withdraw the complaint but agreed to go ahead on the above basis.

The complainant stated that Praluent used to have a black triangle, but as of 16 September 2020, the Electronic Medicines Compendium (eMC) website was updated to remove it.

The complainant stated that due to his/her role he/she was in contact with hospital staff who would be regarded as ‘decision makers’ under the Code and in September 2020 had informed one of those decision makers when the black triangle for Praluent was removed. The decision maker contacted the complainant on 1 October 2020 to tell him/her that in a virtual meeting in the last week with Daiichi-Sankyo, a document used at that meeting showed a black triangle next to alirocumab (Praluent). The decision maker took a photograph of the screen and forwarded it to the complainant (copy provided). The decision maker did not state the specific date of the meeting with Daiichi-Sankyo or the name of the representative, but stated it was in the last week and therefore it must have been after 16 September 2020 when the eMC website was publicly updated.

The complainant stated that there could well be a deliberate motivation by Daiichi-Sankyo to sow doubt about the safety profile of Praluent, so it could displace Praluent with its new product which it was offering for free. Daiichi-Sankyo would surely have been aware that the black triangle had been removed from one of its main competitor products, so the complainant could only think this was a deliberate act to keep using materials showing Praluent with a black triangle.

The complainant alleged breaches of the Code because the material used in the meeting was not accurate and disparaged Praluent by giving the impression of a safety concern which was unwarranted. Therefore, this also breached the Code including Clause 2 because high standards had not been maintained and discredit had been brought to the industry.

The detailed response from Daiichi-Sankyo is given below.

The Panel noted that the screenshot provided by the complainant appeared to be the same as the first page from a Free of Charge Scheme Communications Document provided by Daiichi-Sankyo titled NILEMDO▼ (bempedoic acid) Free of charge (FOC) scheme. Under the subtitle Executive Summary, it stated ‘A Free of Charge (FOC) scheme is available for NILEMDO when used in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia who are considered high/very-high risk and who are statin intolerant or for whom a statin is contraindicated and who are not at goal with ezetimibe but are not eligible for alirocumab▼ or evolocumab’. The Panel noted that according to its certificate, the material was certified on 3 September 2020.

The Panel noted that whilst the black triangle had been removed from the Praluent SPC on the eMC website on 16 September 2020, Daiichi-Sankyo stated that it did not become aware of it until 22 September 2020. The Panel noted Daiichi-Sankyo’s submission that it had no evidence that the material at issue had been used at any meetings between 22 September and 5 October 2020 as the material used at meetings with health professionals was not recorded in its system. The Panel noted, however, that the sales force was only instructed to stop using the material at issue on 5 October 2020 when new material without the Praluent black triangle was issued. The Panel considered therefore that, on the balance of probabilities, material which associated Praluent with a black triangle would have likely been in use between 16 September and 5 October 2020 and the material was not up-to-date at that time and this was disparaging. The Panel therefore ruled breaches of the Code.

The Panel noted that the Code required that materials were up-to-date and queried why Daiichi-Sankyo was not aware that the SPC for Praluent had been updated on the eMC website to remove the black triangle until six days after it had occurred, and why it had not withdrawn the out-of-date material in question as soon as it became aware of the change. The Panel considered that high standards had not been maintained in that regard and a breach of the Code was ruled.

The Panel did not consider that the particular circumstances of this case warranted a ruling of a breach of Clause 2 which was used as a sign of particular censure and reserved for such use. No breach of the Code was ruled which was upheld on appeal by the complainant.