Background
Summary of Council decision:
Two issues were investigated, one was Upheld and one Not upheld.
Ad description
A website, www.breastlight.com, was headed "Breastlight: for Earlier Detection". Further text stated "... over 80% women [sic] have reported to feel more confident with the use of Breastlight because it enlightens breast awareness. Breast cancer is a global epidemic so it is the need of time [sic] to be breast aware for women."
Issue
A GP challenged whether:
1. the claim "Breastlight: for Earlier Detection" was misleading and could be substantiated in relation to the reference to breast cancer; and
2. the claim "enlightens breast awareness" was misleading, irresponsible and could be substantiated.
Response
1. PWB Health Ltd (PWB Health) supplied links on their website to abstracts of clinical trials, which included the dataset and statistical analysis from one of these trials which they said showed the device compared well to [X-ray] imaging and histology. They said that it would be irresponsible for them to market the product as a check for breast cancer as it was less effective at detecting it than X-ray mammography and they marketed the device as an aid to breast awareness in order to ensure women did not rely on the product over medical check-ups or clinical tests. PWB Health said the product packaging, promotional materials and manual made clear that the device was to be used as part of normal breast awareness and any changes detected should be reported to their doctor. The advertiser also submitted a market research study which indicated that women would use the device as part of their normal breast awareness routines and it increased the frequency of their breast awareness routines. Links to online videos, in the form of endorsements and testimonials, were also supplied which included various healthcare professionals and women who discussed the product as an aid to checking their breasts. In some instances, the video highlighted instances where it was claimed small, previously undetected breast lumps had been found.
PWB Health said that if a change occurred then it will be detected earlier as woman would carry out more regular checks, therefore the act of checking more regularly would lead to earlier detection of changes. Because of this they believed they were justified in making the claim "for earlier detection".
2. PWB Health supplied an independent market research survey conducted among 1087 women. The study assessed how women used the device and its effect on their attitude to breast awareness and screening. The advertiser said the results showed the product would be used in addition to a woman's current breast awareness and screening routine rather than a substitute and indicated that the product encouraged more frequent breast awareness.
They said they were aware of the ongoing debate among the medical community about the pros and cons of breast awareness and breast self-examination (BSE). Because of this they said they promoted the device as an aid to breast awareness as that was a responsible way to address both viewpoints and the phrase "enlightened breast awareness" did not promote BSE over breast awareness.
Assessment
1. Upheld
The ASA noted the clinical trials were done within hospitals. One was conducted in a symptomatic breast clinic where the women had been referred by their GPs. The device was used by healthcare professionals who we considered would have greater expertise examining breasts compared to most consumers. We also noted the ad was directed at consumers rather than health professionals. We acknowledged the advertiser's argument that use of the device could encourage more frequent breast awareness and therefore a problem could be identified earlier in its progression. The results of the market research indicated that women may use the device as part of, and to increase the frequency of, their normal breast health routine. However, as the clinical and market research did not follow the women over time, or address whether breast problems had been detected earlier, we did not consider the survey or clinical research sufficient evidence to support the claim.
We also considered whether the videos supported the advertised claim. However, because they were not supported by objective evidence we did not consider them robust substantiation for the claim that using the product could result in earlier detection of changes in the breast.
Because we had not seen robust substantiation that Breastlight could detect problems earlier we concluded the ad was likely to mislead.
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),
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.
and
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule
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.
).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
(Medicines, medical devices, health related products and beauty products).
2. Not upheld
We understood that breast awareness and BSE was an ongoing debate among the medical community and acknowledged that it was the choice of consumers on the advice of their medical practitioner as to how they monitored their breast health. We noted the word "enlightened" was a play on the name and mechanism of the device and that it used the word "awareness" which consumers would be likely to understand to be a general reference to breast health; also, the results of the market research showed the device was used as part of breast awareness routines, not a substitute. Because the claim was stated in general terms and did not recommend one specific type of examination we concluded the ad was not irresponsible.
On this point ad we investigated the ad 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) but did not find it in breach.
Action
The ad must not appear in its current form. We told PWB Health to hold robust evidence before making claims for early detection.
