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ASA Adjudication on BabyJabs Ltd

BabyJabs Ltd

14 Wimpole Street
London
W1G 9SX

Date:

8 August 2012

Media:

Internet (on own site)

Sector:

Health and beauty

Number of complaints:

1

Complaint Ref:

A11-176003

Background

Summary of Council decision:

Three issues were investigated, all of which were Upheld.

Ad

Claims on www.babyjabs.co.uk/mmr, about a children's immunisation service, stated "What is the MMR vaccine? MMR is a 3-in-1 vaccine that protects against measles, mumps and rubella (German measles). The NHS and most medical authorities believe that it offers your child the safest and most effective protection against the three diseases. However, some doctors, including BabyJabs' Dr Richard Halvorsen, are concerned that the vaccine may cause major problems in some children ... How safe is the MMR vaccine? Can the vaccine cause autism? Fears were aroused that the vaccine might be causing autism and bowel disease in some children following the publication of research in 1998 ... At around the time of the introduction of the MMR, the number of cases of autism being diagnosed started to increase dramatically, and some feared that the MMR might have triggered this rise. Experts debated whether the rise was even real, or whether it was due to increased recognition and diagnosis of autism. Most experts now agree that the large rise has been caused partly by increased diagnosis, but also by a real increase in the number of children with autism. Research, including large population studies, has since shown that the MMR is not causing the large majority of autism, but has been unable to exclude the possibility that it is causing autism in a small number of susceptible children". That text was linked to references cited at the bottom of the website. Further text continued "This means that the vaccine could be causing autism in up to 10% of autistic children in the UK - between 300 and 400 children a year. The vaccine strain measles virus has been found in the guts - and brains - of some autistic children; this research supports many parents' beliefs that the MMR vaccine has caused autism in their children". That text was linked to references cited at the bottom of the website.

Issue

The complainant challenged whether:

1. the claim "Most experts now agree that the large rise [in autism] has been caused partly by increased diagnosis, but also by a real increase in the number of children with autism" was misleading and could be substantiated.

2. the claim "the [MMR] vaccine could be causing autism in up to 10% of autistic children in the UK - between 300 and 400 children a year" was misleading and could be substantiated; and,

3. the claim "The vaccine strain measles virus has been found in the guts - and brains - of some autistic children; this supports many parents' belief that the MMR vaccine has caused autism in their children" was misleading and could be substantiated.

CAP Code (Edition 12)

Response

1. BabyJabs Ltd provided documentation and citations which they maintained supported the claim and said one citation referred specifically to the association between MMR vaccine and autism.

2. They said the claim was based on the accuracy or 'statistical power' of the epidemiological studies which had found no association between the MMR vaccine and autism. They said the studies traditionally presented their findings with 95% confidence limits, which represented the range that was likely to contain the true result within 95% probability. They stated that a paper published in 2002 was considered one of the strongest pieces of evidence that the MMR vaccine did not cause autism and provided a copy. They said it found a relative risk of autism in children vaccinated with MMR compared to children not vaccinated with MMR of 0.92 (95% confidence interval: 0.68–1.24), and therefore the authors were 95% sure that the actual relative risk lay between 0.68 and 1.24, and that meant that there was a reasonable possibility of a positive relationship between the vaccine and autism, with the 95% confidence limits going well over the 1.10 or 10% level. They said the lead author of the study had stated "We cannot rule out the existence of a susceptible subgroup with an increased risk of autism if vaccinated". They said that nearly all the other epidemiological studies purporting to show no association between the vaccine and autism also had confidence limits at or above the 1.10 or 10% mark.

They said The Truth about Vaccines (Gibson Square 2009), a book published by Babyjab's medical director, Dr Richard Halvorsen, stated "Every year the number of children estimated to develop autistic spectrum disorder (ASD), the broader classification of autism, is about twelve thousand (based on the latest research findings that around 1 in 60 children have ASD). If one in eight hundred MMR vaccinations triggered an autistic disorder, this would result in around twelve hundred children a year in the UK being made autistic by the bundling of the vaccines. This is probably the worst case scenario. In medical terms this would still be described as an 'uncommon' side-effect of the MMR, but it would actually account for 10% of all autistic children in Britain in a year". They maintained that an epidemiologist at the Health Protection Agency had conceded that there were no epidemiological studies that disproved that the MMR could be causing up to 10% of autism cases. They said that was because such a small proportion could not be picked up by epidemiological studies.

They added that the claim should also be read in the context in which it appeared, which stated "Research, including large population studies, has since shown that the MMR is not causing the large majority of autism, but has been unable to exclude the possibility that it is causing autism in a small number of susceptible children. This means that the vaccine could be causing autism in up to 10% of autistic children in the UK - between 300 and 400 children a year". On that basis, they considered that the website included an acknowledgement that studies had demonstrated that the MMR vaccine was not causing autism on a large population level but that it could still be causing relatively small numbers of cases. They said the figure of 300 to 400 cases a year was calculated as 10% of the newly diagnosed autistic children every year in the UK, assuming an incidence of between 1 in 150 and 1 in 200. They said that was a conservative estimate as the latest figures suggested a prevalence of 157 per 10,000 children, representing an incidence of 1 in 64 as calculated in a paper published in 2009. They provided that paper.

3. They provided documentation which they maintained supported the claim; a study and two abstracts which related to the measles virus found in the gut, and another study which related to the brain.

Assessment

1. Upheld

The ASA understood that the complainant maintained that the claim was contradicted by other research which stated "Most data indicate increased recognition and reporting as primary factors, but the epidemiologic data are insufficient to determine if there has been a true increase in the incidence of ASD", but that Babyjabs maintained that that study pre-dated the documentation they had provided.

We noted that the claim appeared on a website promoting a children's immunisation service, but which did not offer the MMR vaccine, and was featured in a section headed "How safe is the MMR vaccine? Can the vaccine cause autism?", which put forward some background information regarding the introduction of the MMR vaccine. It stated "At around the time of the introduction of the MMR, the number of cases of autism being diagnosed started to increase dramatically, and some feared that the MMR might have triggered this rise. Experts debated whether the rise was even real, or whether it was due to increased recognition and diagnosis of autism" and "Fears were aroused that the vaccine might be causing autism and bowel disease in some children following the publication of research in 1985. At the same time Dr Andrew Wakefield, one of the paper's authors, recommended giving the three single vaccines separately, instead of the triple MMR". Although we noted that that section also stated "This suggestion has been strongly rejected by the government and medical establishment", we considered, in the context of text headed "How safe is the MMR vaccine? Can the vaccine cause autism?" and which referred to links between the MMR vaccine and autism, that consumers were likely to infer from the claim, that the "real increase in the number of children with autism" was not just down to increased diagnosis, but the vaccine might have played a role in bringing about that increase.

We understood that the position held by the World Health Organisation (WHO) and the Department of Health (DH) was that no evidence existed of a causal association between the MMR vaccine and autism or autistic disorders, and that the Cochrane review, looking at the general evidence available, could find no significant association between MMR immunisation and autism.

We noted that the evidence provided by the advertiser included studies and an article which looked at the increased prevalence of autism, but did not include evidence that any increase was due to the MMR vaccine.

We noted that, on balance, the evidence provided by the advertisers suggested that there was an increased prevalence in children with autism. However, we considered that, in the context in which it appeared, the claim "Most experts now agree that the large rise [in autism] has been caused partly by increased diagnosis, but also by a real increase in the number of children with autism" could be understood to mean that the increase might be in part related to the MMR vaccine, but because we had not seen supporting evidence that that was the case, and understood that that position was also contradicted by general medical opinion, we concluded that the claim was misleading.

On that point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.11, 3.13 (Exaggeration), 4.2 (Harm and offence), 12.1 and 12.14 (Medicines, medical devices, health-related products and beauty products).

2. Upheld

We acknowledged that the claim appeared in a context which stated "Research, including large population studies, has since shown that the MMR is not causing the large majority of autism, but has been unable to exclude the possibility that it is causing autism in a small number of susceptible children", but did not detail the basis on which the claim was calculated in any further detail. We therefore considered that consumers would understand from the claim that the MMR vaccine was likely to have caused autism in up to 10% of autistic children in the UK, namely between 300 and 400 children a year. We noted, however, that the claim relied on a number of assumptions, based on the statistical analysis and extrapolation from the results in studies which did not support a link between the MMR vaccine and autism. We noted we had not seen any evidence, such as a clinical trial or study, which actively showed that the MMR vaccine was likely to cause autism in between 300 and 400 children a year.

Because we did not consider that we had seen sufficient evidence to support the claim "the [MMR] vaccine could be causing autism in up to 10% of autistic children in the UK - between 300 and 400 children a year", we concluded that the claim was misleading.

On that point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.11, 3.13 (Exaggeration), 4.2 (Harm and offence), 12.1 and 12.14 (Medicines, medical devices, health-related products and beauty products).

3. Upheld

The ASA noted that the complainant understood that subsequent research had failed to replicate the original findings of the study on which he understood that the claim had been based. We noted that the advertisers maintained that the research to which the complainant had referred either pre-dated the documentation they had provided, or did not relate to the presence of the vaccine strain measles virus in the guts or brains.

We noted the context in which the ad appeared and, as set out under point 1, considered that, in light of that context, consumers would be likely to infer from the claim "The vaccine strain measles virus has been found in the guts - and brains - of some autistic children; this supports many parents' belief that the MMR vaccine has caused autism in their children" that the presence of the vaccine strain measles virus in the guts and brains of some autistic children could be the cause of their autism and that there was consequently a link between the MMR vaccine and autism.

We noted that the body of evidence provided included two abstracts, rather than full studies and a study which had looked at three subjects only. We considered that the overall evidence did not draw conclusions on a link between the MMR vaccine and autism. Because of that, and because we also understood that that position was contradicted by general medical opinion, we concluded that the claim was misleading.

On that point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.11, 3.13 (Exaggeration), 4.2 (Harm and offence), 12.1 and 12.14 (Medicines, medical devices, health-related products and beauty products).

Action

The claims must not appear again in their current form.

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