Background
Summary of Council decision:
Seven issues were investigated, all of which were Upheld.
Ad description
A website for a children's immunisation service offering separate measles, mumps and rubella vaccines, www.childrensimmunisation.com, stated "All our thousands of patients are healthy, with no autism, no hospitalizations or fits (anaphylaxis [sic] shock) no febrile convulsions. We have a 100% Safety Record and have given over 70,000 vaccinations (over 18,000 patients)". The left-hand side of the web page listed links to additional web pages.
The link "Autism" led to a web page where text stated "Some parents cite vaccination as a cause of their child's autism. As they noticed their child's behaviour changed after a vaccination against the 3 diseases of MMR. These parents have had payouts for vaccine damage and a recent high court case in Italy proved that their child's autism could be traced to a vaccine containing all 3 viruses in one injection given against the 3 diseases of MMR as the direct cause".
An additional link, "Single MMR", led to a web page which stated "In October 2008 Hannah Poling an autistic child won a huge payout from a triple vaccine manufacturer, who said that she had a DNA genetic predisposition to become autistic given the MMR vaccine" and "In 2009 a Dr Walker in the USA has studied 275 autistic children and found in a large percentage of the cases that these children had the live Measles virus living in their gut after vaccination with the triple MMR".
A further link, "Vaccines", led to a web page which stated "Also the virus that is in our preferred vaccine is not the same as that found in autistic chilsdrens [sic] guts nor the same as used in the triple MMR that the manufacturer lost the class action with, involved in the Poling case".
Issue
The ASA received six complaints.
1. The ASA challenged whether the website advertised prescription-only medicines (POMs) to the general public in breach of the Code.
2. Three complainants, including a GP, challenged whether the claim "[w]e have a 100% Safety Record" was misleading and could be substantiated.
3. Two complainants challenged whether the ad was irresponsible and could cause fear and distress, because it appeared during a measles outbreak in Wales.
4. Five complainants challenged whether the ad misleadingly implied that there was a link between the single MMR vaccine and autism.
5. One complainant challenged whether the claim in relation to the Italian court case was misleading and could be substantiated, because they did not believe the case had established a causal link between the single MMR vaccine and autism.
6. One complainant challenged whether the claim in relation to Hannah Poling was misleading and could be substantiated, because they believed the payout was from a US Government body and the reason cited for the payout was incorrect.
7. Two complainants challenged whether the implied claim, in relation to Dr Walker's study, that he had found a link between the single MMR vaccine and autism, was misleading and could be substantiated, because they believed Dr Walker had refuted that interpretation of his work.
Response
Children's Immunisation Centre Ltd (Children's Immunisation Centre) said their website did not constitute advertising and should be deemed as an information web portal that dealt with many childhood diseases. They did however provide a response to our enquiries. They said their website kept many children safe, especially those with impaired immune systems, and offered a safe alternative for parents who needed to have their children protected from childhood diseases, but did not wish to undergo government or NHS programmes.
1. Children's Immunisation Centre said MMR stood for Mumps, Measles and Rubella and the acronym was not brand advertising for a POM.
2. Children's Immunisation Centre supplied a sample of their complaints log which they said indicated there were no safety issues for any of their 20,000 patients. They said each patient had a record card and not one child had been hospitalised or had regression, autism or other health issues post vaccination. They said because parents were paying for a vaccination, Children's Immunisation Centre would have been informed if an issue arose.
3. Children's Immunisation Centre said their website was not irresponsible as parents who had seen vaccine damage, had heard about regression or other problems after vaccination, now had a viable alternative.
4. Children's Immunisation Centre said the Italian court case had established a link between MMR and autism and there was currently a case at the UK High Court where the parents had video proof that showed a child pre and post vaccination.
5. Children's Immunisation Centre said there was no other listed cause for the autism in the case of the Italian child and the parents own evidence indicated the MMR vaccine caused the autism. They submitted a newspaper report to support their assertion.
Children's Immunisation Centre also submitted data in the form of a graph which they said questioned the coincidence of the increase and decrease of ASD (Autism Spectrum Disorder) and MMR uptake.
6. Children's Immunisation Centre said the Hannah Poling case was factual and broadly evidenced on the internet. They said they would amend the statement which ensured it was clear the payout was from a government body.
7. Children's Immunisation Centre said Dr Walker had found measles virus in the gut of autistic children but no one could say either way, based on that evidence, whether the virus caused the autism or the autism would have arisen anyway. They said there was evidence from regular parent's statements that MMR caused regression and autism. Because of that, Children's Immunisation Centre did not feel the information was alarmist or misleading. They submitted a weblink which they said was a preliminary study that found acetaminophen (paracetamol) use after measles, mumps and rubella vaccination was associated with autistic disorder.
Assessment
The ASA noted Children's Immunisation Centre's assertion that their website did not constitute advertising. However, because we considered the website was directly connected with the sale and transfer of goods and services, in this instance, the sale of individual MMR and other vaccinations, we concluded it was subject to the CAP Code.
1. Upheld
The ASA acknowledged marketers of health services could advertise their services. We noted Children's Immunisation Centre had not used brand names for their vaccines. However, we considered the vaccines offered were POMs and the CAP Code prohibited the advertising of POMs to the public.
Because the website advertised prescription-only medicines, we concluded it breached the Code.
On this point the ad breached CAP Code (Edition 12) rule 12.12 12.12 Prescription-only medicines or prescription-only medical treatments may not be advertised to the public. (Medicines, medical devices, health related products and beauty products).
2. Upheld
We noted the sample of Children's Immunisation Centre's complaint log which confirmed that some children had developed minor and major complications as a result of receiving a vaccination. Complications ranged from rash and high temperature to emergency hospital admission.
Because Children's Immunisation Centre did not have a 100% safety record, we concluded the claim was misleading.
On this point the ad breached CAP Code (Edition 12) rule 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).
3. Upheld
We considered the website had probably been live for some time before the outbreak of measles in Wales, during April and May 2013. However, we noted two links referenced the Welsh measles outbreak. One link stated "protect your self [sic] and your family against the deadly measles". An additional link stated "Warning to parents after outbreaks of measles, rubella and whooping cough … MEASLES CAN KILL, DO NOT IGNORE IT".
We acknowledged it was responsible for consumers to be advised to take up government-recommended vaccination especially during a disease outbreak. However, because Children's Immunisation Centre promoted non-government recommended vaccination and because the overall context of the website focused on their claim that a single MMR vaccination was linked with autism, we considered the language used could have caused fear and distress without justifiable reason and we concluded the website was irresponsible.
On this point the website breached under CAP Code (Edition 12) rules 1.3 1.3 Marketing communications must be prepared with a sense of responsibility to consumers and to society. (Social responsibility and 4.2 4.2 Marketing communications must not cause fear or distress without justifiable reason; if it can be justified, the fear or distress should not be excessive. Marketers must not use a shocking claim or image merely to attract attention. (Harm and offence).
4 & 5. Upheld
We did not receive any scientific evidence that supported a link between the MMR vaccine and autism. We noted the court in Italy had awarded compensation to the parents of a child who had been given a single MMR vaccination. However, we did not consider a ruling in one specific case could be seen as the basis to support a claim relating to MMR and autism for the wider population. In addition, because the UK High Court had not reached a decision regarding the case cited by Children's Immunisation Centre, it was not possible to establish the basis for the legal proceedings or the specific matters of that case.
Because we had not seen robust evidence that linked a single MMR vaccine with autism we concluded the website was misleading.
On this point the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
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) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health related products and beauty products).
6. Upheld
We understood compensation was paid out to Hannah Poling's family by a US Government Health Body and not the vaccine manufacturer. We also noted the Government body had not gone so far as to establish a link between the vaccinations Hannah Poling had received and autism. We acknowledged that Children's Immunisation Centre had assured us the reference to Hannah Poling would be amended. However, because the ad at the time it was seen contained inaccurate information about the circumstances of that case and implied a link between the single MMR vaccine and autism, we concluded it was misleading.
On this point the ad breached CAP (Code) 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).
7. Upheld
We noted Children's Immunisation Centre's comment regarding measles virus in the gut and the reference to a study of paracetamol use. We considered the reference to Dr Walker's study could be interpreted as linking the MMR vaccine with autism. We noted a statement from the hospital where Dr Walker had worked clearly stated he had not demonstrated a link between the presence of measles virus in the gut and autism. We acknowledged the reference to a study of paracetamol use, however because the study was not supplied in full we were not able to assess it thoroughly. Furthermore, because the study referenced post-vaccination paracetamol use and autism we considered it was insufficient evidence to support a direct link between a single MMR vaccination and autism. We also noted Children's Immunisation Centre's response that parent's had stated MMR had caused autism. However, we did not consider parental reporting of issues, in the absence of robust evidence, was sufficient substantiation to support the claim.
Because the ad implied autism was linked to the MMR vaccine and we had not seen robust evidence to support that claim, and because the reference to Dr Walker's study was inaccurate, we concluded the ad was misleading.
On this point the ad breached CAP Code (Edition 12)
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
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) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health related products and beauty products).
Action
The ad must not appear again in its current form. We told Children's Immunisation Centre not to promote POMs and to remove claims not supported by objective scientific evidence.
CAP Code (Edition 12)
1.3 12.1 12.12 3.1 3.3 3.7 4.2
