An anonymous contactable complainant who described him/herself as a health professional and later became non contactable, complained about an advertisement by Daiichi-Sankyo UK Ltd for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) published in ‘Guidelines in practice’. The complainant also raised concerns about two digital advertisements for Nilemdo and Nustendi and one for Lixiana (edoxaban).
The complainant stated that the ‘Guidelines in practice’ advertisement included the claim ‘When you and your patients are fighting to take back cholesterol control, add on oral, once-daily NILEMDO or NUSTENDI.*1,2’. The asterisk took the reader to some small text at the bottom of the page which included information about concomitant use with simvastatin >40 mg daily being contraindicated and restrictions on the use of simvastatin 40 mg daily for certain patients; the complainant stated that such important information about maximum dosage and contraindication should not have been presented as small text at the bottom of the advertisement but as part of the main overarching claim at the top. Many patients would be taking a high dosage of simvastatin so adding Nilemdo or Nustendi without dosage adjustment, as the claim at the top read, would cause side effects and harm. The complainant alleged that the claim was not appropriate.
The complainant alleged that two Daiichi-Sankyo digital advertisements for Nilemdo and Nustendi did not mention simvastatin dosing information. The opening frame included ‘add on to take back control’ and the other frames had diluted messaging of ‘add on to bring down’. The complainant alleged that the frames were misleading in isolation as a health professional would think to initiate Nilemdo or Nustendi in any patient taking any dosage of simvastatin without problems. Such mass advertising for black triangle products without important dosage information in prominence was concerning. The fact that footnotes had been used in the hard copy advertisement signalled that this information was to be carefully covered to perhaps exploit market share.
The complainant alleged that a digital advertisement for Lixiana (edoxaban) did not have a visible generic name.
The detailed response from Daiichi-Sankyo is given below.
The Panel considered the immediate and overall impression of the journal advertisement to a busy health professional. The Panel noted that the claim in question, ‘When you and your patients are fighting to take back cholesterol control, add on oral, once-daily NILEMDO or NUSTENDI*’, when read in isolation, was ambiguous with regard to what exactly the medicines were being added to. Whilst the Panel noted that Nilemdo and Nustendi could each be used alone as an adjunct to diet in certain patients, it considered that the advertisement in question overall appeared to be promoting the addition of Nilemdo and Nustendi to existing lipid lowering medicines particularly given that the claim immediately beneath the claim at issue referred to LDL-C reduction depending on, inter alia, ‘concomitant medicine’. The Panel therefore considered that the claim at issue within the context of the advertisement, when read alone without the corresponding footnote, misleadingly implied that there would be no concerns when adding Nilemdo and Nustendi to any existing lipid lowering medicine which was not so; Nilmedo and Nustendi were both contraindicated with concomitant simvastatin >40 mg daily and the important safety information within the footnote to the claim at issue, which was in much smaller font size and was not in the same visual field as the claim, might have been missed by a busy health professional. In the Panel’s view, given that simvastatin was a commonly prescribed lipid lowering treatment, and given Nilemdo and Nustendi’s indications as an add on treatment, the contraindication regarding concomitant use with simvastatin >40mg daily needed to be immediately apparent to health professionals in materials.
The Panel therefore considered that the claim ‘When you and your patients are fighting to take back cholesterol control, add on oral, once-daily NILEMDO or NUSTENDI*’, within the context of the advertisement, was misleading and the small footnote at the bottom of the advertisement did not negate the misleading impression given which could not be substantiated. Breaches of the Code were ruled including that high standards had not been maintained.
The Panel noted its comments and rulings above and considered that the misleading impression given by the claim at issue within the context of the advertisement had the potential to adversely affect safety in patients taking simvastatin >40mg daily, which the Panel considered was a commonly prescribed lipid lowering medicine, and a breach of Clause 2 was ruled.
Whilst the Panel considered that the first digital advertisement was ambiguous with regard to what exactly the medicines were being added to, it considered that, on balance, none of the frames, nor the advertisement overall, implied that the medicines could be added to any existing lipid-lowering regime or specifically statins or simvastatin >40mg. The Panel noted the indications of Nilemdo and Nustendi, in particular, that each could be used alone as an adjunct to diet in certain patients. Further, frame five included the only reference to other lipid lowering medicines and in that regard referred to the recommendation by NICE for bempedoic acid with ezetimibe where statins were contraindicated or not tolerated and where ezetimibe alone did not control LDL-C well enough. The Panel thus did not consider that failure to mention simvastatin dosing information within the body of the banner meant that the advertisement was misleading nor that the claims 'add on to take back control' and ‘add on to bring down’ in the context of the material in question were incapable of substantiation on the very narrow point alleged and, on balance, no breaches of the Code were ruled including Clause 2.
Nor did the Panel consider that, read in isolation, the frames would mislead a health professional to initiate Nilemdo or Nustendi in any patient taking any dosage of simvastatin as alleged and no breach was ruled.
The Panel noted that the second digital advertisement at issue consisted of the same seven frames to the first digital advertisement but in a different layout with the link to indications, prescribing information etc and reference to being intended for UK health professionals being at the bottom of each frame. The Panel noted that its comments and rulings in relation to the digital advertisement above applied here and the Panel similarly ruled, on balance, no breaches of the Code including Clause 2.
Nor did the Panel consider that the complainant had established that inclusion of the footnotes in the hard copy advertisement and not the digital advertisements meant that this information was hidden to exploit market share as alleged and no breach was ruled in that regard.
The Panel noted that the Lixiana advertisement at issue consisted of four frames; each frame had, inter alia, a headline claim regarding Lixiana to the left and the Lixiana logo with the non-proprietary name appearing beneath it in the top right-hand corner. The Panel noted that although the non-proprietary name did not appear immediately adjacent to the brand name at its first appearance within the advertisement in question, it did appear below the brand name within the logo on each frame and, based on the complainant’s very narrow allegation, that the generic name was not visible at all, the Panel ruled no breach of the Code.
The Panel did not consider that in the particular circumstances of this case Daiichi-Sankyo had failed to maintain high standards and no breach was ruled.