An anonymous complainant, who described him/herself as a health professional complained about errors and omissions on the Roche Products Ltd Resources website.
The complainant provided a link to a particular page and alleged that the generic name for Gazyvaro was not legible.
The complainant further referred to text directly above all of the product logos that:
‘Our aim is to develop new and improved therapies that offer benefits over existing treatment options Roche has a portfolio of therapies for the treatment of cancer as well as diseases including haemophilia, central nervous system disorders, lung disorders and inflammatory diseases.’
The complainant alleged that not all the products displayed on this page were new as many had been on the market for more than 12 months.
The complainant stated that the marketing authorisations for these products were very specific and by only referring to cancer, haemophilia etc, this was promoting outside of the licence as one could easily assume all the products were for any form of cancer etc. It was not clear from the product logos underneath the claim which products were licensed for which indications precisely and for a health professional this was misleading and off-label promotion which would have a risk to patient safety. By claiming benefits over existing therapies, this was misleading as the actual benefits had not been qualified or stated anywhere on the page.
The complainant provided a link to a second page which promoted Phesgo and noted the claim ‘PHESGO is a new combined fixed-dose subcutaneous (SC) formulation of pertuzumab and trastuzumab that requires just 20–38 minutes for administration and monitoring1’. The complainant alleged that the 20-38 minutes was misleading as the 20 minutes only related to the maintenance dose of the product, 38 minutes was always the time taken for a loading dose administration. The complainant alleged that it was a patient safety risk to claim lower time of administration without segregation of the different time intervals for the different types of treatments.
The complainant provided a link to a third page which included the claim ‘With the sustained protection of HEMLIBRA, life can be beautifully spontaneous’. The complainant alleged that this was a false and misleading claim as one could interpret this as life would be beautiful after taking hemlibra.
The complainant provided a fourth link to a webpage on which the dosing section for Ocrevus claimed ‘OCREVUS is dosed every 6 months’. The complainant alleged that this was false as the summary of product characteristics (SPC) stated to provide the initial dose of 600mg in 2 infusions (first infusion and the second infusion 2 weeks later). Important safety information that patients should be monitored during the infusion and for at least one hour after the completion of the infusion was missing as part of this claim. This would have a grave patient safety impact. The SPC also said:
‘The following two premedications must be administered prior to each Ocrevus infusion to reduce the frequency and severity of IRRs (see infusion-related reactions in section 4.4 for additional steps to reduce IRRs):
• 100 mg intravenous methylprednisolone (or an equivalent) approximately 30 minutes prior to each Ocrevus infusion;
• antihistamine approximately 30-60 minutes prior to each Ocrevus infusion;.’
The complainant stated that this information had been missed on the dosing claim as it only mentioned dosing at 6 months and no further information was provided.
The website and the different sections mentioned within this complaint had allegedly breached Clause 2 repeatedly by not adhering to patient safety values.
The detailed response from Roche is given below.
1 Medicines Webpage
The Panel noted that for electronic advertisements, the Code required the non-proprietary name of the medicine to appear immediately adjacent to the brand name at its first appearance in a size such that the information was easily readable. From the material provided by Roche, the non-proprietary name for Gazyvaro, obinutuzumab, appeared to be small and blurry, and was thus not easily readable. The Panel therefore ruled a breach of the Code.
The Panel considered that the statement ‘Our aim is to develop new and improved therapies that offer benefits over existing treatment options’ did not appear to refer to any particular product as being new, including any of the fourteen medicines listed on the page that were referred to as products currently supported on the website and were therefore already developed. The Panel therefore ruled no breach of the Code.
The Panel also did not consider that the complainant had established that referring to Roche’s aim to develop ‘improved therapies that offer benefits over existing treatment options’ without qualification of the actual benefits constituted a misleading comparison as alleged and no breach of the Code was ruled.
With regard to the statement ‘Roche has a portfolio of therapies for the treatment of cancer as well as diseases including haemophilia, central nervous system disorders, lung disorders and inflammatory diseases’, the Panel considered that the statement was referring to Roche’s portfolio and the therapy areas in which the products in its portfolio fell and was not referring to the indications of the products listed. The Panel noted Roche’s submission that the website provided further information via a direct link for the products listed. The Panel did not consider that the complainant had established that the statement constituted off license promotion of any of the fourteen medicines listed as alleged. The Panel ruled no breaches of the Code in relation to each medicine.
2 Phesgo Webpage
The Panel noted that the claim ‘PHESGO is a new combined fixed-dose subcutaneous formulation of pertuzumab and trastuzumab that requires just 20–38 minutes for administration and monitoring’ was referenced to the SPC. Table 1 titled ‘Phesgo recommended dosing and administration’ in Section 4.2 of the Phesgo SPC provided timings for the loading dose and maintenance dose with the approximate duration of subcutaneous injection for the loading dose and maintenance dose was 8 minutes and 5 minutes, respectively; the observation time was 30 minutes and 15 minutes, respectively. The Panel noted Roche’s submission that the 20-38 minutes was calculated by combining the ‘Approximate duration of subcutaneous injection’ and ‘Observation time’ columns for the Phesgo loading and maintenance doses. The Panel further noted Roche’s submission that on the same webpage was a box titled ‘Dosing and administration’ where the administration and observation times for the loading and maintenance doses were explained. The Panel considered that whilst a health professional would likely read the dosing and administration section on the webpage in question or refer to the SPC for more detailed dosing information, each webpage must not be misleading when read in isolation. Nonetheless, the Panel did not consider that the complainant had established that the claim in question, by referring to a time range of 20-38 minutes for administration and monitoring without segregation of the different time intervals for loading and maintenance doses was misleading as alleged. The complainant had not established that the claim in question was incapable of substantiation. No breaches of the Code were ruled.
3 Hemlibra Webpage
The Panel noted that Hemlibra was indicated for use in certain patients for routine prophylaxis of bleeding episodes in haemophilia A. Whilst the Panel considered that it was unclear what was meant by ‘life can be beautifully spontaneous’ and noted Roche’s lack of submission in this regard, it considered that the complainant had not established that the claim ‘With the sustained protection of HEMLIBRA, life can be beautifully spontaneous’ implied that life would be beautiful after taking Hemlibra as alleged. Based on the very narrow allegation, the Panel ruled no breaches of the Code.
4 Ocrevus Webpage
The Panel noted that the Ocrevus SPC stated that the initial 600mg dose was to be administered as two separate 300mg intravenous infusions, 2 weeks apart, and that subsequent doses would be administered as a single 600mg infusion every 6 months. The first subsequent dose of 600mg should be administered six months after the first infusion of the initial dose. Whilst the Panel noted Roche’s submission that the claim ‘OCREVUS is dosed every 6 months’ was only in relation to dose cadence, the Panel considered that this would not be immediately apparent to readers. The Panel considered that the statement within the section titled ‘Dosing’ lacked the important information that the initial dose required two separate infusions two weeks apart and that the first subsequent dose of 600mg should be administered six months after the first infusion of the initial dose. The Panel considered that the claim was misleading in that regard and incapable of substantiation and therefore ruled breaches of the Code. The Panel noted that it appeared that there was further information on dosing, albeit that needed to be expanded with an additional click, beneath the claim and thus did not consider that in the particular circumstances of this case Roche had failed to maintain high standards. No breach of the Code was ruled.
The Panel noted that the Ocrevus SPC stated Ocrevus treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions and who have access to appropriate medical support to manage severe reactions such as serious infusion-related reactions. The Panel noted Roche’s submission that Ocrevus was administered intravenously which, without exception, occurred in a controlled and monitored hospital environment. The Panel further noted that within the section on the webpage at issue titled ‘Dosing’ below the claim ‘Ocrevus is dosed every 6 months’ it stated ‘Find out how to: Dose Ocrevus; Store Ocrevus; Prepare Ocrevus; and Administer Ocrevus’ and appeared to provide the option for readers to click on each for further information. Whilst the Panel did not have the information within each subsection before it, it noted Roche’s submission that additional relevant information was provided in the links directly below the posology statement. The Panel considered that readers would likely access the required information in relation to each of the labelled topics. The Panel noted that each webpage must not be misleading when read in isolation. Nonetheless, the Panel did not consider that the complainant had established that referring to the dosing of Ocrevus every six months without referring to the requirements for premedication and monitoring was misleading as alleged; readers were directed to information on how to administer Ocrevus and no breaches of the Code were ruled.
The Panel noted its comments and rulings above and, overall, did not consider that a breach of Clause 2, which was a sign of particular censure, was warranted and no breach was ruled.