Background
Summary of Council decision:
Three issues were investigated, all of which were Upheld.
Ad description
The website www.medscans.co.uk promoted thermography. On the home page, text under the heading "What is Thermography?" stated "Thermography is a medically recognised, non invasive, accurate screening method used for detecting disease at early stage & to visualise pain in the body". On the page entitled "Thermography" text stated "What is breast thermography? Digital Infrared Thermal Imaging (Thermography) has been comprehensively researched for more than 30 years, and was approved by the FDA [Food and Drug Administration] for breast cancer screening in 1982. While it should not replace Mammography, it has many valuable functions, namely: 1. early detection of neovascular patterns (blood supply) - giving a physiological picture of the body. 2. It provides improved detection for women with dense breasts. 3. It can serve as an adjunct to inconclusive mammograms ... Applications of thermography Breast Screening Body Screening Pain Visualisation Early Stage Disease Detection".
Issue
1. The complainants challenged whether the claims "approved by the FDA for breast cancer screening in 1982" and "Thermography is a medically recognised ... accurate screening method" were misleading and could be substantiated;
2. One of the complainants challenged whether the claims that thermography could be successfully used for "Breast Screening", "Body Screening", "Pain Visualisation" and "Early Stage Disease Detection" were misleading and could be substantiated.
3. One of the complainants challenged whether the ad could discourage consumers from seeking essential treatment for a condition for which medical supervision should be sought.
Response
Medical Thermal Imaging Ltd t/a medscans.co.uk said they took great care to ensure the information on their site was accurate and that they held robust medical evidence in support of their claims.
1. Medical Thermal Imaging referred to the National Centre for Biotechnology Information’s website which they said stated “In 1982, the FDA approved the first breast thermography device as an adjunctive breast cancer screening procedure”. They also provided an extract from an article published in the Daily Mail, in 2006, entitled “Could heat scans replace mammograms?” which included a doctor from a respected hospital discussing the potential for thermography to be used in the assessment of breast cancer. They also provided an extract from a pilot study to prove the accuracy of the procedure.
2. Medical Thermal Imaging provided extracts from three studies which referred to breast cancer and thermography, in relation to the claim that it could be used for “breast screening”. They named five studies which referred to the relationship between cancerous cells and temperature, as well as an extract from a biomedical handbook, to show that thermography could be used for the early detection of precancerous and malignant cells. They also explained how thermography could assist with pain visualisation; that it had been approved for that purpose by a number of American organisations; and that studies indicated it provided very reliable results.
3. Medical Thermal Imaging stated that their aim was to provide women with information about both anatomical and physiological screening tests, to enable them to make an ethical and informed decision.
Assessment
1. Upheld
The ASA considered that consumers reading the claims would believe that thermography was recognised as a proven, safe and effective tool for screening by the medical community and that the FDA had approved thermography for breast cancer screening in 1982. We also considered that consumers could be encouraged to enquire further about the service or book an appointment, as a result.
We understood that while the FDA had approved thermography as an adjunctive to mammography in 1982, they had never approved it as a primary screening method. We also considered that a news article referring to the alleged potential of thermography for breast cancer screening and extracts from one pilot study were not sufficient to demonstrate that it was a medically recognised or accurate screening tool. Further, we noted that there was no mention of thermography as an appropriate screening method on the NHS Choices website, and that both the Royal College of Radiologists (RCR) and Cancer Research UK provided guidance in relation to thermography which stated that currently there was not sufficient evidence to support the use of thermography in breast cancer screening, nor was there sufficient evidence to show that thermography provided benefit to patients as an adjunctive tool to mammography. We understood that neither endorsed or recommended it as a screening technique. In light of that guidance, and in the absence of adequate evidence to substantiate the claims, we concluded that they were misleading.
On that 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.
(Medicines, medical devices, health-related products and beauty products).
2. Upheld
We noted the ad stated that thermography should not be used as a “replacement” for mammography, but was instead an “adjunct to mammography and physical examination”. The ad also emphasised the fact that thermography could be used to detect “early signs of abnormality … before an invasive tumour growth occurs” so that, in combination with other tools, a woman had “… a much better chance of detecting cancer at its earliest stage”. Therefore, we considered that, in the context in which it appeared, consumers would understand the references to “Breast Screening” to mean that thermography was a tool that could aid the diagnosis of breast cancer. In relation to the references to “Body Screening", "Pain Visualisation" and "Early Stage Disease Detection”, we noted there was no additional text on the page to explain how thermography could be used in those circumstances and therefore we considered that consumers would understand that thermography could be used to successfully locate and detect disease and the causes of pain. We reviewed the documents provided, but noted that Medical Thermal Imaging had not supplied any full studies, and so we were unable to review the methodology utilised and the conclusions reached in their entirety. We considered that the extracts provided were not sufficient to demonstrate the efficacy of the technique. Further, as stated in point one, we noted that, in relation to breast cancer screening, both the RCR and Cancer Research UK had concluded that there was insufficient evidence to suggest that thermography provided benefit to patients as a adjunctive tool to mammography. Because of that, and in the absence of any evidence to show that thermography could detect abnormalities indicating the early development of breast cancer and therefore aid diagnosis, locate the causes of pain, or the early stages of disease more generally, we concluded that the claims were misleading.
On that 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.
(Medicines, medical devices, health-related products and beauty products).
3. Upheld
As discussed in point 2 above, we considered that consumers would understand that thermography was a tool that could aid the diagnosis of breast cancer. We also noted the requirement of the Code that specific advice on, diagnosis of, or treatment for conditions for which medical supervision should be sought should not be offered unless that advice, diagnosis or treatment was conducted under the supervision of a suitably qualified health professional. We noted breast cancer was a condition for which medical supervision should be sought, however, we had not seen evidence that the breast thermography offered by Medical Thermal Imaging was carried out under the supervision of a suitably qualified health professional. Therefore, we concluded that the ad was in breach of the Code.
On that point, the ad breached CAP Code (Edition 12) rule
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).
Action
The ad must not appear again in its current form. We told Medical Thermal Imaging Ltd to ensure they held adequate evidence to substantiate their marketing claims in future, including claims that thermography had been approved by the FDA for breast cancer screening, was medically recognised and could successfully be used for body screening, pain visualisation and early stage disease detection, including as a tool for the diagnosis of breast cancer. We also told them to ensure they did not discourage essential treatment for conditions for which medical supervision should be sought.
