AUTH/3451/1/21 - Complainant v Teva

Teva respiratory website

  • Received
    05 January 2021
  • Case number
    AUTH/3451/1/21
  • Applicable Code year
    2019
  • Completed
    02 December 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
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  • Appeal
    No appeal

Case Summary

An anonymous, contactable complainant who described him/herself as a health professional and later became uncontactable, complained about the Teva UK corporate website and the company’s ‘Let’s Talk Respiratory’ website.

The detailed response from Teva is given below.

1 Teva corporate website (www.tevauk.com)

The complainant stated that when the reader first opened up the website, a disclaimer came up and if readers selected that they were a health professional, a dropdown option came up which allowed them to choose from options including, pain nurse, fertility specialist, oncology nurse. No matter which type of health professional was chosen (so any non-respiratory focused health professional), the respiratory promotional page opened up which was not appropriate as promotion should be tailored to the audience to whom it was directed. For example, promotional material for general practitioners might not be appropriate for hospital doctors and, similarly, material for clinicians might not be appropriate for use with other relevant decision makers. The complainant stated that it beggared belief that an oncology nurse or a urology health professional could be promoted respiratory information.

The complainant noted that five products were mentioned on the page, DuoResp Spiromax (budesonide and formoterol), Braltus Zonda (tiotropium), Qvar (beclometasone dipropionate), Cinqaero (reslizumab) and Tymbrineb (tobramycin). There was, however, no prominent prescribing information link or information on how to find the prescribing information for any of those products unless the reader accidentally clicked on the green plus sign next to them and were lucky enough to scroll right the way down. There was no prescribing information provided for Tymbrineb or Qvar. The complainant further noted that there was no adverse event reporting on the page. It did not appear that the page had been certified as there were so many errors.

The complainant noted that another webpage had brand names/images of all Teva products provided along with information/videos etc without prescribing information or the adverse event reporting statement being provided. The information on all of Teva medicines could be accessed by members of the public. In that regard, the complainant provided a link to a page which had information on DuoResp Spiromax alongside a picture of the inhaler showing branding and the ability to ask questions. There was even a ‘How do I use my DuoResp Spiromax (Budesonide/formoterol fumarate dihydrate) Inhaler? Please watch this video for more information on how to use your DuoResp Spiromax (Budesonide/formoterol fumarate dihydrate) Inhaler’. The complainant alleged that that would not be appropriate for members of the public to see as the inhaler branding was present. It was the same for various products including on the page for acitretin.

The Panel noted Teva’s submission that its corporate website, tevauk.com, was open access until readers selected the pages that were intended for health professionals. When doing so, a pop-up box appeared asking readers to confirm that they were a health professional and requesting that they select their area of specialisation which could have been ‘other health professional’ if they preferred not to disclose their specialism. The Panel noted Teva’s submission that the selection of health professional specialty was for Teva’s information so it could gather insights into and understand who was using the website, and to inform the company’s plans about additional content; it was not used to send bespoke information or redirect readers post the selection. Upon confirmation that they were health professionals, readers could access all information for health professionals on the whole website which included all Teva products marketed in the UK.

The Panel noted that the relevant clause of the Code stated that material should only be sent or distributed to those categories of persons whose need for, or interest in, it could reasonably be assumed. The supplementary information stated that material should be tailored to the audience to whom it was directed. In the Panel’s view, the clause applied to material proactively sent or distributed to recipients and not to material which a health professional proactively sought out as in the case of material on a company’s website.

Noting its comments above, the Panel did not consider that the availability of the information on the health professional respiratory section of the tevauk.com website, to all health professionals, was in breach of the Code as alleged and no breach was ruled.

The Panel noted Teva’s submission that when the health professional respiratory in focus webpage was first loaded, only the five medicines brand and generic names were visible and no other product information. The Panel noted from the webpages provided by Teva, which were current at the time of the complaint, that when the green plus sign next to each product was selected, additional information was displayed for each of the five products. The Panel noted Teva’s submission that the prescribing information was presented when promotional information was visible, which was why locating the prescribing information along with an adverse statement within the content area, which was hidden until expanded, was appropriate in this instance.

The Panel noted that a hyperlink to the prescribing information for DuoResp Spiromax was visible towards the end of the second page of expanded information for DuoResp Spiromax. Similarly, a hyperlink to the prescribing information for Braltus and Cinqaero was visible and appeared on the first page of expanded information for each. The Panel, however, noted that the Code required that in the case of promotional material on the internet, there must be a clear, prominent statement as to where the prescribing information could be found. In the Panel’s view, noting that the entire webpage for health professionals was promotional, there should have been a clear and prominent statement as to where prescribing information could be found for each of the products listed at the outset and before clicking on the green plus sign for each. The Panel therefore ruled a breach of the Code in relation to each of the five products.

The Panel further noted Teva’s submission that where a claim was made next to a product name, an additional link to prescribing information was provided with a single click; no claims were made with regard to Tymbrineb and Qvar, and only factual reference information provided linked to the SPC. The Panel, however, noted its comments above with regards to the promotional nature of the health professional webpage. Prescribing information for Tymbrineb and Qvar should have been provided but was not. The Panel therefore ruled a breach of the Code in relation to Tymbrineb and Qvar.

The Panel noted that whilst it appeared from Teva’s submission that the adverse event reporting statement was included within the prescribing information, which was linked from the webpages for Braltus Zonda, DuoResp Spiromax and Cinqaero, the Panel did not have a copy of the prescribing information before it. Regardless of its inclusion in the prescribing information, the Panel noted that there was no reference to an adverse event reporting statement at the outset and before clicking on the green plus sign for each medicine or within the expanded information for each medicine when the green plus sign was clicked, including that for Qvar and Tymbrineb. The Panel considered that this was particularly important for Cinqaero given that it was subject to additional monitoring. The Panel therefore ruled a breach of the Code.

The Panel noted Teva’s submission that all information on the website had been certified and reviewed periodically and recertified as required by the Code and provided the certificates. The Panel did not consider that there was evidence to show that the webpage had not been certified as alleged and it therefore ruled no breach of the Code.

The Panel noted its rulings above and considered that Teva had failed to maintain high standards and a breach of the Code was ruled.

Whilst the Panel noted Teva’s submission that the adverse event reporting statement did appear within the prescribing information for Braltus Zonda, DuoResp Spiromax and Cinqaero, there was no prescribing information for Tymbrineb and Qvar. The Panel noted the lack of adverse event reporting statement within the content of the webpages themselves; and was particularly concerned that there was no such statement anywhere in the materials for Tymbrineb and Qvar and that Cinqaero was subject to additional monitoring and only appeared to have the relevant statement within its prescribing information. The Panel noted that the black triangle was an important safety requirement and on balance the cumulative effect of its comments, and rulings of breaches meant that a breach of Clause 2 was warranted, a breach was ruled accordingly.

The Panel noted that the complainant referred to another webpage which could be accessed by members of the public which he/she alleged was inappropriate as it included the brand names/images of all Teva products together with information/videos etc without prescribing information or adverse event reporting information. In that regard, the complainant specifically provided a link to a page which he/she stated provided information on DuoResp Spiromax alongside an image showing branding and the ability to ask questions. The complainant noted that it also included a video titled ‘How do I use my DuoResp Spiromax (Budesonide/formoterol fumarate dihydrate) Inhaler?’.The complainant alleged that it was the same for various products including acitretin.

The Panel noted that the complainant did not appear to have a complaint about the first cited page link which listed products alphabetically by generic name referring briefly to patient information leaflets, presentation and the medical information service. This page did not include brand names etc referred to by the complainant which appeared on links from that webpage. The Panel considered that all of the allegations on this point related to the budesonide and acitretin webpage.

The Panel noted that should information about a specific medicine directed at patients for whom the prescribing decision had already been made be provided on the public section of a company website, the sections for each target audience should be clearly separated and the intended audience identified at the outset. Text above the video link was insufficient in this regard. The Panel noted that it appeared that the video which was aimed at patients for whom the prescribing decision had already been made was an integral part of the reference information aimed more broadly at the general public. The Panel therefore ruled a breach of the Code. The Panel considered that Teva had failed to maintain high standards and a breach of the Code was ruled.

The Panel noted that in order to obtain further information including the product’s indication, the reader had to download the patient information leaflet or SPC or watch the video which appeared beneath. The Panel noted that the video titled ‘How to use your DuoResp Spiromax (Budesonide/formoterol fumarate dihydrate) inhaler appeared to be given as a response to the first of five FAQs ‘How do I use my DuoResp Spiromax (Budesonide/formoterol fumarate dihydrate) inhaler’ and stated Please watch this video for more information on how to use DuoResp Spiromax. The Panel noted that the first slide of the video stated ‘This video is intended for patients prescribed DuoResp Spiromax’. It was the only FAQ response visible on the page; the other FAQs could be read if the ‘View all questions’ link below the video or the FAQ tab towards the top of the page were selected and were general in nature including how does Teva choose what colours to use on packaging, what to do if the reader suffered a side effect or adverse event and how to get a new copy if the PIL if it was lost.

The Panel noted the narrow nature of the allegation, that the information including reference to brand names and the video which included inhaler branding was not suitable for the general public. The Panel noted that Teva had described the material as reference information as set out in the supplementary information of the Code. The Panel noted Teva’s submission that the page listed the Teva products as reference information and provided training for patients who recognized and differentiated the devices better visually; the current brand image mentioned by the complainant was with reference to differentiating inhalers and training for patients.

The Panel noted its ruling above and considered that this adequately covered the complainant’s concerns in relation to the video. The Panel noted that the complainant bore the burden of proof and did not consider that the complainant had established, on the balance of probabilities, that the inclusion of brand names and imagery on the webpage intended for the public was contrary to the Code or that the requirements in relation to promotion were triggered. The Panel, therefore, based on the complainant’s narrow allegation, ruled no breaches of the Code.

The Panel noted that at the bottom of the DuoResp Spiromax webpage it stated ‘If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the Patient Information Leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. The Panel therefore ruled no breach of the Code.

In relation to acitretin, the Panel noted that the information provided on the acitretin webpage, was similar to that for budesonide, although there was no video. The FAQs on the actitretin webpage were all general in nature including how does Teva choose what colours to use on packaging, what to do if the reader suffered a side effect or adverse event and how to get a new copy if the PIL if it was lost.
The Panel noted its comments above and did not consider that the complainant had established, on the balance of probabilities, that the inclusion of brand names and images was promotional for actitretin as alleged and thus that the requirements of of the Code in relation to promotion were triggered or was not in line with the requirements of the Code based on his/her allegation. The Panel, therefore, based on the complainant’s narrow allegation, ruled no breaches of the Code.

The Panel noted that the acitretin webpage did appear to be directed to both the public and patients that had been prescribed acitretin; certain text on the webpage addressed patients. The Panel noted that the webpage included the statement ‘This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See www.mhra.gov.uk’. Further the bottom of the page included, albeit in small font, information about how to report side effects. The Panel therefore ruled no breach of the Code.

Whilst the Panel had concerns about the adequacy of audience signposting, which it considered was covered by its comments and rulings above, the Panel did not consider that the complainant had established that using the brand name and images of Teva products in relation to budesonide and acitretin was in breach of the requirement that material should only be distributed to those categories of persons whose need for, or interest in, it could reasonably be assumed. In the Panel’s view, this clause applied to material proactively sent or distributed to recipients and not to material which a health professional proactively sought out as in the case of material on a company’s website. The Panel, based on the complainant’s narrow allegation, ruled no breach of the Code.

The Panel noted its comments and rulings in relation to the budesonide and acitretin patient pages and 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.

2 ‘Let’s Talk Respiratory’ website (letstalkrespiratory.com)

The complainant noted that the website included a talk on key insights from clinical guidelines on the diagnosis and management of asthma and chronic obstructive pulmonary disease (COPD). The presentation included mention of inhaled corticosteroids (ICS) and inhaled corticosteroids combined with long acting beta agonists (ICS/LABA) and ICS-formoterol with snippets from the guidelines. The complainant noted that Teva had a product for both of these drug classes ie Qvar (ICS) and DuoResp Spiromax (ICS/formoterol). The complainant noted that there was no prescribing information provided for those products. Although only drug class was mentioned, this was a promotional talk hosted on a website initiated and generated by Teva so it was obvious there was a clear focus on DuoResp and Qvar. Furthermore, the mention of ICS-formoterol with a small asterisk at the bottom stated that it was not licensed in the UK which was off-label promotion for DuoResp Spiromax as the SPC licence for DuoResp Spiromax was not in line with what the Global Initiative for Asthma (GINA) guidelines recommended ICS-formoterol for.

The complainant noted that on the side of the video/webpage it was hosted on, there was the option to share the video via Facebook, Twitter or LinkedIn which demonstrated a lack of knowledge from Teva as members of the public could be promoted to and alleged that it was disguised and open promotion of Teva products by sharing on social media. The complainant noted that the option to share content via Facebook, LinkedIn or Twitter was available also on the knowledge section of the same website which was highly inappropriate.

The complainant alleged that another article (ref UK/RESP/17/0028au) on the website about using budesonide/formoterol ‘as needed’ to prevent asthma was disguised promotion. The complainant stated that there was no prescribing information provided for DuoResp again considering the article was about budesonide/formoterol. It had a promotional intent and all promotional requirements had not been met and yet again it was an article that could be shared on social media. The complainant alleged that same breaches of the Code as with the video above.

The Panel noted Teva’s submission that ‘Let’s Talk Respiratory’ was a non-promotional website dedicated to education and included supportive materials, resources and some of the latest news in respiratory for both health professionals and patients. The Panel further noted Teva’s submission that the presentation in question reflected key insights from the various clinical guidelines for asthma and COPD and no products were mentioned in the non-promotional educational video including aspects of those various guidelines.

The Panel considered that, regardless of whether such presentations were categorised by the company as promotional or non-promotional, all such presentations should have good quality clear educational content; that a presentation had good quality educational content did not in itself determine whether the presentation was promotional or non-promotional. The very broad definition of promotion in the 2019 Code was particularly relevant. In that regard, the Panel noted that it was an accepted principle under the Code that it was possible, given the broad definition of promotion, for material to be promotional without mentioning the product by name.

The Panel noted Teva’s submission regarding how health professionals and members of the public were directed to the relevant sections of the site, including the use of the field force in relation to health professionals and its advertising on the health professional section of Teva’s corporate website which, in the Panel’s view, was promotional. The Panel noted Teva’s submission that the field force was briefed that LTR was non-promotional and shouldn’t be used alongside any promotional calls. The Panel further noted Teva’s submission that all topics on the website were generated by the health professional led editorial board to ensure topics and subsequent contents were completely independent to Teva; Teva did, however, review and certify it to ensure consistency with the Code. The Panel noted that the website appeared to have been funded by Teva; that there was an editorial board did not necessarily mean that the website was non promotional given the broad definition of promotion as noted above.

The Panel noted Teva’s submission that the presentation in question was an educational, non-promotional resource which focused on published guidelines. The Panel noted that the beginning of the presentation explained the differences in the guidelines with regards to diagnosing asthma and COPD particularly within the context of the Covid pandemic. One slide out of nineteen titled ‘How different are we?’ included a diagram which briefly mentioned the initial steps in treating asthma by class noting the differences between the National Institute for health and Care Excellence (NICE), British Thoracic Society (BTS) and GINA guidelines. According to the slide, NICE Asthma 2020 stated that LTRA were the next step after ICS monotherapy, BTS Asthma 2019 stated that ICS/LABA was the next step after ICS monotherapy, and GINA Asthma 2020 stated that ICS/formoterol was the first step* in preference to ICS monotherapy. The Panel noted that the asterisk took the reader to a small footnote at the bottom of the slide which read ‘Currently off-license use in the UK’.

The Panel noted Teva’s submission that the presenter detailed that the GINA recommendation was not licensed as was appropriate. The Panel noted that from the transcript of the presentation at issue provided by Teva, the speaker stated ‘Where we have a bit of an outlier is with GINA. So, GINA, their first step, the preferred step is to use ICS/formoterol, and even though this is unlicensed in the UK, it's something that has been demonstrated in studies to be an effective way of reducing the amount of steroid that's used, but without having an effect on the number of exacerbations. So, ICS/formoterol is probably something that will be used increasingly in an as required manner. But for now, NICE and BTS largely talk about ICS monotherapy and then moving on in subsequent steps to ICS/LABA on a regular basis’.

The Panel noted that whilst the presentation did not specifically mention DuoResp Spiromax or Qvar, it referred to ICS/formoterol and ICS/LABA. The Panel noted that a number of ICS/formoterol combination inhalers were available on the market and DuoResp Spiromax was one of three budesonide/formoterol inhalers on the market. Nonetheless, in the Panel’s view, the website promoted ICS/formoterol and ICS within the combination of an ICS/LABA and Teva marketed both of these products, namely Qvar (ICS) and DuoResp Spiromax (ICS/formoterol).

In the Panel’s view, given the very broad definition of promotion and noting its comments above, including that it was a company website albeit with an editorial board, that health professionals were directed to it including from the health professional section of Teva’s corporate website which in the Panel’s view was promotional and Teva’s involvement in its review, the website could not be considered anything other than promotional for Teva’s medicines.

The presentation was an integral part of the website. The Panel considered that the presentation at issue should have included Qvar and DuoResp Spiromax prescribing information and a clear prominent statement of where it could be found and did not include either. The Panel therefore ruled breaches of the Code.

The Panel noted Teva’s submission that there was the ability to report adverse events via the website at the bottom of all the relevant pages. The Panel therefore ruled no breach of the Code.

Noting its view that the website and video in question were promotional, the Panel considered that the recommendation to use ICS-formoterol as a reliever when required as often as needed was inconsistent with its licensed indication. According to its SPC, DuoResp Spiromax was indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) was appropriate in patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β2 adrenoceptor agonists or in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

The Panel did not consider that the small footnote at the bottom of the page, which stated that it was not licensed in the UK, was sufficient to negate promotion that was inconsistent with the particulars listed in its SPC. A breach of the Code was ruled. The Panel considered that Teva had failed to maintain high standards in this regard and a breach of the Code was ruled.

The Panel noted that a ruling of a breach of Clause 2 was a sign of particular censure and reserved for such. The Panel noted its rulings and comments above but considered that the matter was not such as to bring discredit upon, or reduce confidence in, the industry. No breach of the Code was ruled.

The Panel did not consider that the presentation was intended for patients taking a specific prescription only medicine and therefore ruled no breach of the Code in relation to the requirement for a side effect reporting statement to be included on the material .

The Panel, noting its comments above, considered that the sharing of the promotional presentation via social media would constitute the promotion of a Teva prescription only medicine to the public. The Panel noted that the complainant bore the burden of proof and had not established that it had been shared and thus the Panel ruled no breaches of the Code in this regard.

The complainant alleged that an article on the website about using budesonide/formoterol ‘as needed’ to prevent asthma was disguised promotion. The complainant stated that there was no prescribing information provided for DuoResp again considering the article was about budesonide/formoterol. It had a promotional intent and all promotional requirements had not been met and yet again it was an article that could be shared on social media. The complainant alleged that same breaches of the Code as with the video presentation above.

The Panel noted that the article at issue, also on the letstalkrespiratory.com website, was entitled ‘Research roundup: Budesonide-formoterol used as needed to prevent asthma exacerbations: a trial reflecting real-world practice’. The Panel noted Teva’s submission that the article referred to a scientific publication in the New England Journal of Medicine and as per other content of the website was non-promotional and was intended as non-promotional education as per the original paper and reflected the author’s conclusions of the study and did not promote any product.

The Panel noted that the article stated ‘The authors suggest that budesonide-formoterol taken as needed was superior to both as-needed SABA and maintenance budesonide plus as-needed SABA at reducing the risk of severe exacerbations. As such therapy with budesonide-formoterol taken when the patient perceived their symptoms to be worsening can avoid symptoms becoming severe enough to warrant further urgent care. The study extends previous finding regarding the use of reliever therapy to avoid asthma exacerbations, providing evidence from a study that reflects real-world clinical practice’.

The Panel noted Teva’s submission regarding how health professionals and members of the public were directed to the relevant sections of the site including the use of the field force in relation to health professionals and its advertising on the health professional section of Teva’s corporate website which in the Panel’s view was promotional. The Panel further noted Teva’s submission that all topics on the website were generated by the health professional led editorial board to ensure topics and subsequent contents were completely independent to Teva; Teva did, however, review and certify it to ensure consistency with the Code.

The Panel noted that whilst the presentation did not specifically mention DuoResp Spiromax, it referred to budesonide/formoterol and included, in the Panel’s view, promotional claims for it. The Panel noted that a number of budesonide/formoterol combination inhalers were available on the market and DuoResp Spiromax was one of three budesonide/formoterol inhalers on the market. Nonetheless, the Panel considered that the website promoted budesonide/formoterol and Teva marketed this product, namely DuoResp Spiromax. In the Panel’s view, noting its comments above regarding how health professionals were directed to it, and Teva’s involvement in its review, the article could not be considered anything other than promotional for Teva’s medicine. The Panel considered that the article in question should have included DuoResp Spiromax prescribing information and a clear prominent statement of where it could be found and did not include either. The Panel therefore ruled breaches of the Code.

The Panel noted Teva’s submission that there was the ability to report adverse events via the website at the bottom of all the relevant pages. The Panel, therefore, ruled no breach of the Code.

The Panel did not consider that the article was intended for patients taking a specific prescription only medicine and therefore ruled no breach of the Code in relation to the requirement for a side effect reporting statement to be included on the material.

The Panel noted the complainant’s allegation that there was the option to share the article via Facebook, Twitter or LinkedIn. The Panel, noting its comments above, considered that the sharing of the promotional article via social media would constitute the promotion of a Teva prescription only medicine to the public. The Panel noted that the complainant bore the burden of proof and had not established that it had been shared and thus the Panel ruled no breaches of the Code.