A national press ad for Viagra Connect, seen on 19 April 2018, included text which stated “4.3 million men in the UK experience erectile problems* … *Figures based on men reporting occasional and frequent difficulty getting or maintaining an erection, ref Kantar TNS Omnibus Survey Dec 2010 in a survey of 1,033 men. Stats are UK unless stated otherwise”.
The complainant challenged whether the claim “4.3 million men in the UK experience erectile problems” was misleading and could be substantiated.
Pfizer Consumer Healthcare Ltd said that erectile dysfunction (ED) was the inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse and that it was an easily recognisable condition which men were able to self-diagnose. The definition was in line with the indication for Viagra Connect which was “the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance”. Viagra Connect had been reclassified from a prescription only medicine to a pharmacy medicine by the MHRA in November 2017. One of the aims of the reclassification was to provide a public health benefit to the UK population to help encourage engagement with health care professionals and get men into the healthcare system. They said ED was one of the symptoms of underlying cardiovascular issues and by encouraging men into the health care system it was hoped that it could help prevent future cardiovascular events. They explained that it was important to normalise the condition and therefore the introduction of prevalence information was key to helping men suffering from ED understand that they were not alone.
Pfizer explained that in the past 20 years, there had been numerous reports on the prevalence of ED. The prevalence rates, however, varied depending on the population surveyed. They said there was also a lack of recent UK specific data, so in 2010 they commissioned consumer research survey on men 25–75 years of age. The study was a Kantar TNS Omnibus Survey and the research was undertaken on a representative sample of the UK population. In the study 1,033 men in the UK were surveyed and asked a number of questions relating to erectile problems and medications they may have used to treat the problems. The research was performed via a 5-minute Online Omnibus Survey, which recruited a sample representative of the UK population. Pfizer provided us with a copy of the questions and a breakdown of the age of the survey respondents.
The ASA considered that the ad made clear the number of people surveyed and that consumers would therefore understand the claim “4.3 million men in the UK experience erectile problems” was based on a survey of 1,033 men conducted in 2010. We noted that the ad referred to men who suffered from ‘erectile problems’ and not ED. We considered that consumers would therefore understand that the claim related to anyone who experienced erectile difficulties and not only those who had a formal diagnosis of ED. We further considered that consumers would understand the claim to be a prevalence claim about the conditions that the product might be relevant to, namely erectile problems, and that it was not a safety, health or efficacy claim about the product.
As the ad referred to those with erectile problems, we considered that a survey where the respondents self-reported the instances in which they had suffered erectile problems and was sufficiently robust would be adequate to substantiate the claim as it would be understood by consumers.
The research was undertaken by a third-party company and consisted of a short online survey. The survey was given to a representative panel of 1,033 men aged between 25 and 75 and consisted of questions which specifically addressed any erectile problems they had had in the previous 12 months only. It included questions about difficulty getting an erection hard enough for sexual penetration and difficulty keeping an erection long enough to complete sex. The survey used a scale to assess frequency of symptoms and allowed men to choose from the options ‘rarely’, ‘occasionally’ or ‘frequently’ as their response to the questions. The total number of respondents who reported they had had erectile problems in the last 12 months was based only on those who answered that the problems occurred occasionally or frequently. The report stated that 221 of the 1,033 men surveyed suffered from occasional or frequent erectile problems, which equated to 21.4% of the total number. The report then explained that, based on the most recent population statistics (available for mid-2016), 21.4% of the total population of men aged 25 to 75 in the UK was 4.3 million. The confidence level for the statistic was 95%, which was industry standard.
We understood that the MHRA, who had also seen the evidence, were satisfied that 4.3 million was a reasonable estimate of prevalence. They further said they had no reason to believe that the number would have significantly changed since the study was conducted in 2010.
We considered that the age ranges in the population sample and the total number of people surveyed was sufficiently representative of the male population. We noted that the test had been conducted in 2010 and then extrapolated to 2016 population statistics. We considered that best practice would have been for the claim to be based on a study conducted more recently. However, as the ad made clear the survey to which it related, we were, overall, satisfied that if the study was to be re-run the number was likely to be very similar to 4.3 million and the survey used was robust enough to substantiate the prevalence claim. We therefore concluded that the ad was not misleading.
We investigated the ad under CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising) and 3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation. (Substantiation), but did not find it in breach.
No further action required.