Case Summary
A health professional complained about the promotion of the buprenorphine implant, Sixmo following his/her participation in a market research campaign by Accord UK Ltd.
Sixmo 74.2mg implant was indicated for substitution treatment for opioid dependence in clinically stable adult patients who required no more than 8mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
The complainant alleged that this ill-conceived campaign was derogatory as it treated patients with addiction as puppets. Talking to colleagues, the complainant knew that this view was a consensus. The complainant was therefore shocked that, despite the feedback, Accord had progressed with this demeaning campaign. The complainant alleged that by treating patients this way and not listening to advice it sought that Accord had not maintained high standards and the material caused offence to the complainant as a prescriber on behalf of his/her patients who had been depicted condescendingly. The complainant also alleged that by not acting on market research feedback, Accord had also breached Clause 2 and had brought the industry into disrepute.
The detailed response from Accord is given below.
The Panel acknowledged that extreme dissatisfaction was usually necessary on the part of an individual before he or she was moved to submit a complaint.
The Panel noted that the complainant had not provided any of the materials about which he/she was concerned. In reviewing the material provided by Accord, the Panel noted that the health professional leave piece (Ref UK-03077 Date of preparation: September 2021) was headed ‘Help to cut the ties that addiction brings’ followed by an image of a puppet of a male painter and decorator in dungarees with some strings attached to a winding mechanism (which appeared would make the puppet move) and other strings cut. A later page within the leavepiece included the same heading as the first page followed by a list of features of the medicine with an image this time of the same puppet dressed smarter in a shirt and no longer connected to a winding mechanism. A similar theme was used in other material (ref UK-03319, Health & Justice Exhibition Stand) which also included the heading ‘Help to cut the ties that addiction brings’ and images of two different puppets, a female and a male, and referred to six reasons to use Sixmo.
The Panel accepted that some health professionals would be critical of the campaign and noted that whilst some negative comments were reported from the market research, there were also positive comments. Around 67% of the UK participants in the market research either liked it, mostly liked it or very much liked it. The intended audience, those treating addiction, would, like any audience, have different views about sensitive subjects. It was not clear whether the complainant was referring to the comments from colleagues involved in the market research or colleagues who had seen the campaign generally as the consensus view that the campaign was ill-conceived. In any event, the campaign did not appear to be inconsistent with the market research. The Panel noted Accord’s submission that it had made changes to the campaign as a result of the market research.
The Panel noted the submission from Accord about patients being controlled by their addiction. The material included the explanation about cutting the ties of addiction and in the Panel’s view, on the evidence provided, it did not appear to be an unreasonable approach to treating addiction. The Panel considered that although some readers might not like the campaign and would be offended, the Panel did not consider that the campaign did not recognise the special nature of medicines nor did it fail to respect the professional standing or otherwise of the audience. In the Panel’s view, the campaign was not likely to cause offence to most of the audience and the Panel did not consider that Accord had failed to maintain high standards. No breaches of the Code were ruled including no breach of Clause 2.
CASE AUTH/3606/1/22 NO BREACH OF THE CODE
HEALTH PROFESSIONAL v ACCORD
Promotion of Sixmo and use of market research outcomes
A health professional complained about the promotion of the buprenorphine implant, Sixmo following his/her participation in a market research campaign by Accord UK Ltd.
Sixmo 74.2mg implant was indicated for substitution treatment for opioid dependence in clinically stable adult patients who required no more than 8mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
The complainant alleged that this ill-conceived campaign was derogatory as it treated patients with addiction as puppets. Talking to colleagues, the complainant knew that this view was a consensus. The complainant was therefore shocked that, despite the feedback, Accord had progressed with this demeaning campaign. The complainant alleged that by treating patients this way and not listening to advice it sought that Accord had not maintained high standards and the material caused offence to the complainant as a prescriber on behalf of his/her patients who had been depicted condescendingly. The complainant also alleged that by not acting on market research feedback, Accord had also breached Clause 2 and had brought the industry into disrepute.
The detailed response from Accord is given below.
The Panel acknowledged that extreme dissatisfaction was usually necessary on the part of an individual before he or she was moved to submit a complaint.
The Panel noted that the complainant had not provided any of the materials about which he/she was concerned. In reviewing the material provided by Accord, the Panel noted that the health professional leave piece (Ref UK-03077 Date of preparation: September 2021) was headed ‘Help to cut the ties that addiction brings’ followed by an image of a puppet of a male painter and decorator in dungarees with some strings attached to a winding mechanism (which appeared would make the puppet move) and other strings cut. A later page within the leavepiece included the same heading as the first page followed by a list of features of the medicine with an image this time of the same puppet dressed smarter in a shirt and no longer connected to a winding mechanism. A similar theme was used in other material (ref UK-03319, Health & Justice Exhibition Stand) which also included the heading ‘Help to cut the ties that addiction brings’ and images of two different puppets, a female and a male, and referred to six reasons to use Sixmo.
The Panel accepted that some health professionals would be critical of the campaign and noted that whilst some negative comments were reported from the market research, there were also positive comments. Around 67% of the UK participants in the market research either liked it, mostly liked it or very much liked it. The intended audience, those treating addiction, would, like any audience, have different views about sensitive subjects. It was not clear whether the complainant was referring to the comments from colleagues involved in the market research or colleagues who had seen the campaign generally as the consensus view that the campaign was ill-conceived. In any event, the campaign did not appear to be inconsistent with the market research. The Panel noted Accord’s submission that it had made changes to the campaign as a result of the market research.
The Panel noted the submission from Accord about patients being controlled by their addiction. The material included the explanation about cutting the ties of addiction and in the Panel’s view, on the evidence provided, it did not appear to be an unreasonable approach to treating addiction. The Panel considered that although some readers might not like the campaign and would be offended, the Panel did not consider that the campaign did not recognise the special nature of medicines nor did it fail to respect the professional standing or otherwise of the audience. In the Panel’s view, the campaign was not likely to cause offence to most of the audience and the Panel did not consider that Accord had failed to maintain high standards. No breaches of the Code were ruled including no breach of Clause 2.
A health professional complained about the promotion of the buprenorphine implant, Sixmo following his/her participation in a market research campaign by Accord UK Ltd.
Sixmo 74.2mg implant was indicated for substitution treatment for opioid dependence in clinically stable adult patients who required no more than 8mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
COMPLAINT
The complainant stated that he/she participated in market research for this campaign which was one of the most ill-conceived campaigns he/she had seen. The complainant alleged that it was derogatory treating patients with addiction as puppets and advised that his/her patients were not puppets. Talking to colleagues, the complainant knew that this view was a consensus. The complainant was therefore shocked that, despite the feedback, Accord had progressed with this demeaning campaign. The complainant alleged that by treating patients this way and not listening to advice it sought that Accord had breached Clauses 9.1 and 9.2 for not maintaining high standards and the material caused offence to the complainant as a prescriber on behalf of his/her patients who had been depicted condescendingly. The complainant also alleged that by not acting on market research feedback, Accord had also breached Clause 2 and had brought the industry into disrepute.
The complainant did not provide any material to support his/her complaint. It appeared that the complainant was referring to Clauses 9.1 and 9.2 of the 2019 Code and Accord was so informed and asked to consider the equivalent requirements of the 2021 Code.
When writing to Accord, the Authority asked it to consider the requirements of Clauses 9.2, 9.1 and 2 of the 2021 Code. This was an error, the equivalent clauses in the 2021 Code were Clauses 5.1 and 5.2.
RESPONSE
Accord referred to the indication for Sixmo in terms of the background to the allegation. The medicine was indicated for substitution treatment for opioid dependence in clinically stable adult patients who required no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment. The promotional campaign in question (copies were provided of the items Accord assumed that the complainant was referring to) was specifically targeted towards health professionals specialising in the field of opioid use disorder.
Market research was conducted to gather insight on four potential images for the proposed marketing campaign in March 2021 with participants from several European countries. Accord provided the results from the UK participants and the market research questions.
Accord was disappointed to receive the complaint and denied all breaches of the Code. Accord’s response to the allegations was summarised below.
Market Research
Accord stated that market research involved gathering data to obtain further insights. Whilst feedback was gathered from a sample of participants, it was not feasible in many instances to incorporate each and every piece of feedback in subsequent outputs, as long as the majority opinion was reflected.
Accord did not undertake market research for every campaign, however, due to the sensitive nature of this therapeutic area, Accord submitted that gathering further insights would be valuable prior to finalising campaign materials. The market research was conducted to ensure its UK campaign reflected the needs and opinions of the majority of its target audience of UK health professionals.
Accord submitted that the UK market research involved 10 participants (general practitioners and psychiatrists specialising in addiction) who responded to questions on each of the four images, resulting in a total of 40 responses. Therefore, Accord was confident that the sample of participants’ views would largely reflect that of the campaign’s target audience. The participants were asked about the proposed campaign and specifically about the suitability of the imagery. Feedback from participants on this particular question was provided and Accord had given an example of a positive and negative comment received. Further comments were provided in the full UK market research findings.
Of the 40 responses, only 6 (15%) related to ‘not liking the puppet imagery’. As the majority of responses clearly liked the imagery, Accord proceeded to use the images but acted on the feedback received to finalise the marketing materials. Examples of the amends made, as a result of the market research, were:
1 Some of the puppets shown at the market research had tattoos. These were removed to try and prevent any potentially perceived stereotyping.
2 An image of scissors was removed as it could be deemed inappropriate in a therapeutic area that has a high self-harm incidence rate.
3 One of the attached strings was kept so that the images did not refer to cutting “all” ties.
4 The background colour was brightened, and the image was softened’.
Imagery Used
Accord submitted that the imagery used within the campaign was intended to help convey the ‘lack of control’ that some patients with opioid addiction might experience. It was not a literal representation of patients with addiction but rather a visual depiction of how some of them might feel. In fact, this feeling of a ‘loss of control’ had been referenced within a number of journals and respected societies with respect to opioid addiction:
o The European Opiate Addiction Treatment Association stated ‘The key criteria indicating that an individual is addicted is when they no longer have control over their drug use’.
o An article in the BMJ stated that ‘Opioid use disorder is characterized by loss of control over the use of opioids resulting in physical, psychological, and social harms’.
o The NHS defined addiction as ‘not having control over doing, taking or using something to the point where it could be harmful to you’.
Furthermore, Accord submitted that the use of imagery to convey patient feelings was wholly relevant to this complex therapeutic area and it was important to convey to health professionals through impactful visuals how metaphorically their patients with addiction and a lack of control might actually feel. This was evidenced with patient testimony, which reinforced why the proposed Sixmo campaign used such metaphorical imagery before being tested in market research:
o A UK patient testimonial on Drug Addicts Anonymous stated ‘I am simply a puppet being controlled by my addiction’. Clearly, they did not believe they were actual puppets but could relate metaphorically.
o A US patient testimony stated ‘Something more powerful than you is pulling your strings like a puppet’. Again, they did not believe they were actual puppets but could relate metaphorically.
The campaign was focused on portraying how patients might feel as well as the role that health professionals had in helping cut the ties that addiction might bring. For example, a patient implanted with Sixmo was not tied to frequent pharmacy visits as they were for short-acting substitution treatment. The imagery helped to emphasise this message.
Accord therefore remained of the view that the use of this imagery was highly relevant in this therapy area and wholly appropriate for this challenging and emotive area. Accord did not believe that the imagery was derogatory in expressing to health professionals how some of their patients with opioid addiction might feel. Accord, therefore, denied any breaches of the Code.
Causing Offence
Accord submitted that ‘offence’ was a subjective matter and in other previous cases the Panel had considered ‘offence’ under several parameters, which Accord believed were relevant:
o Relevance to the therapeutic area, Case AUTH/2304/3/10.
o The majority of readers, Case AUTH/3315/3/20.
o The use of partial nudity, Case AUTH/2503/3/12.
o The use of gimmicks, Case AUTH/2196/1/09.
Summary
Accord submitted that the use of puppets in this therapy area was extremely relevant to the target audience of health professionals. Accord was sorry that the complainant was offended by the imagery and/or offended that his/her opinion did not prevent the campaign using such imagery. The complainant’s view was clearly not established during market research to be a consensus and the outputs of market research did not have to reflect all opinions gathered. Rightly so, Accord submitted that its marketing campaign was based on the majority opinion of the useful insights gathered in well-conducted market research.
Given that the Panel stated in Case AUTH/3315/3/20, ‘it would always be the case that different people would think differently about sensitive subjects’, Accord denied all breaches of the Code and would ask the Panel to consider that, on the balance of probabilities, the majority of the audience for the marketing campaign would not have been offended.
PANEL RULING
The Panel considered that the relevant clauses in the 2021 Code were 5.1 and 5.2. The response from Accord was clearly related to the content of Clauses 5.1 and 5.2, although the letter to the company referred incorrectly to Clauses 9.1 and 9.2 of the 2021 Code and thus the Panel decided to rule on Clauses 5.1 and 5.2 of the 2021 Code.
The Panel acknowledged that extreme dissatisfaction was usually necessary on the part of an
individual before he or she was moved to submit a complaint.
The Panel noted that the complainant had not provided any of the materials about which he/she was concerned. In reviewing the material provided by Accord, the Panel noted that the health professional leave piece (Ref UK-03077 Date of preparation: September 2021) was headed ‘Help to cut the ties that addiction brings’ followed by an image of a puppet of a male painter and decorator in dungarees with some strings attached to a winding mechanism (which appeared would make the puppet move) and other strings cut. A later page within the leave piece included the same heading as the first page followed by a list of features of the medicine with an image this time of the same puppet dressed smarter in a shirt and no longer connected to a winding mechanism. A similar theme was used in other material (ref UK-03319, Health & Justice Exhibition Stand) which also included the heading ‘Help to cut the ties that addiction brings’ and images of two different puppets, a female and a male, and referred to six reasons to use Sixmo.
The Panel accepted that some health professionals would be critical of the campaign and noted that whilst some negative comments were reported from the market research, there were also positive comments. Around 67% of the UK participants in the market research either liked it, mostly liked it or very much liked it. The intended audience, those treating addiction, would, like any audience, have different views about sensitive subjects. It was not clear whether the complainant was referring to the comments from colleagues involved in the market research or colleagues who had seen the campaign generally as the consensus view that the campaign was ill-conceived. In any event, the campaign did not appear to be inconsistent with the market research. The Panel noted Accord’s submission that it had made changes to the campaign as a result of the market research.
The Panel noted the submission from Accord about patients being controlled by their addiction. The material included the explanation about cutting the ties of addiction and in the Panel’s view, on the evidence provided, it did not appear to be an unreasonable approach to treating addiction. The Panel considered that although some readers might not like the campaign and would be offended, the Panel did not consider that the campaign did not recognise the special nature of medicines nor did it fail to respect the professional standing or otherwise of the audience. In the Panel’s view, the campaign was not likely to cause offence to most of the audience. The Panel therefore ruled no breach of Clause 5.2 of the 2021 Code. The Panel did not consider that Accord had failed to maintain high standards and therefore ruled no breach of Clause 5.1 of the Code.
The Panel considered that given its rulings of no breaches of the Code, there was no breach of Clause 2 which was used as a sign of particular censure and ruled accordingly.
Complaint received 24 January 2022
Case completed 17 October 2022
