This case was in relation to allegations that representatives promoting Nilemdo and Nustendi did not make clear within sales calls using sales aids and leavepieces that these products should not be used in combination with a simvastatin dosage greater than 40mg. The complainant was further concerned that representatives had not been trained properly or given clear briefing in this regard.
The Panel ruled a breach of the following Clauses of the 2021 Code because in its view:
• certain slides within the two sales aids (refs BEM/21/0626 and BEM/21/0828) specifically made reference to the therapeutic use of Nilemdo and Nustendi in combination with a statin but those slides did not make the contraindication in patients taking simvastatin >40mg daily immediately apparent to readers. The inclusion on subsequent slides was not sufficient to negate the misleading impression given that Nilemdo and Nustendi could be used in combination with any dose of any statin, which could not be substantiated.
• the failure to refer to the contraindication with simvastatin > 40mg on the first and fourth pages of two leavepieces (ref BEM/21/0653 and BEM/21/0816) gave the misleading impression that Nilemdo and Nustendi could be used in combination with any dose of simvastatin which was not so and reference to the contraindication on the other pages was not sufficient to negate the misleading impression which could not be substantiated.
• within the two briefing documents (BEM/21/0827 and BEM/21/0829), it was not made sufficiently clear that Nilemdo and Nustendi could not be used in combination with simvastatin > 40mg, whenever there was reference to combination with statins or other lipid-lowering therapies (LLTs), and therefore representatives had not been given clear briefing on the contraindications with simvastatin and the need to mention it when making claims about combining Nilemdo and Nustendi with other cholesterol lowering agents as alleged.
• a number of concerns had been raised across a number of materials and breaches of the Code had been ruled and it considered that the repeated failure to comply with the Code on this matter was particularly serious and might prejudice patient safety and was such as to reduce confidence in, and bring discredit upon, the pharmaceutical industry.
Breach of Clause 6.1
Making a misleading claim
Breach of Clause 6.2
Making an unsubstantiated claim
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 2
Bringing discredit upon, and reducing confidence in,
the pharmaceutical industry
The Panel ruled no breach of the following Clauses of the 2021 Code because:
• it noted that the complainant’s allegation related to general training activities rather than the specific briefing materials considered and ruled in breach of the Code above, and considered, based on the evidence before it, that it had not been established that representatives had not been trained properly on mandatory contraindications around simvastatin as alleged
• on balance, noting that the complainant had not detailed specific sales calls, it considered on this very narrow ground that it had not been established that representatives did not make clear reference to the contraindication with simvastatin >40mg during sales calls as alleged:
No Breach of Clause 6.1
Requirement that claims/information/comparisons must not be misleading
No Breach of Clause 17.1
Requirement that representatives must be given adequate training and have sufficient scientific knowledge to enable them to provide full and accurate information about the medicines which they promote
This summary is not intended to be read in isolation.
For full details, please see the full case report below.